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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Drug Safety Enhancement Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2012 · first_quarter · Q1
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013: FDA related provisions (no bill number) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013: HHS related provisions (no bill number) FY 2013 Budget Resolution: Health related provisions
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
Source: Senate LDA
Generating Antibiotic Incentives Now Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
Medicare Drug Savings Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: All provisions including Medicare Part B and 340B Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking: Provisions related to the AMP calculation, definition of line extension, and extension of the rebate to the territories Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking: Provisions related to implementation of the Sunshine reporting provisions of the Affordable Care Act Dual eligibles coordination policy issues
Medical Gas Safety Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
Preserving Access to Life-Saving Medications Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
340B Program Improvement Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
Guidance Accountability and Transparency Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
Food and Drug Administration Mission Reform Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
Stop Online Piracy Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
Counterfeit Drug Penalty Enhancement Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
MODDERN Cures Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
Drug Shortage Prevention Act of 2012
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
Protecting Consumer Access to Generic Drugs Act of 2012
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
Online Pharmacy Safety Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
FAST Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
EXPERRT Act of 2012
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
SAFE DOSES Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
Medicare Decisions Accountability Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: All provisions including Medicare Part B and 340B Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking: Provisions related to the AMP calculation, definition of line extension, and extension of the rebate to the territories Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking: Provisions related to implementation of the Sunshine reporting provisions of the Affordable Care Act Dual eligibles coordination policy issues
To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
Medicare Prescription Drug Savings and Choice Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: All provisions including Medicare Part B and 340B Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking: Provisions related to the AMP calculation, definition of line extension, and extension of the rebate to the territories Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking: Provisions related to implementation of the Sunshine reporting provisions of the Affordable Care Act Dual eligibles coordination policy issues
Safe Doses Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
For the relief of Rona Ramon, Asaf Ramon, Tal Ramon, Yiftach Ramon, and Noah Ramon.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
Patent Continuing Disclosure Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 243, Patent Lawsuit Reform Act of 2011: false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generics H.R. 1056, Patent Continuing Disclosure Act: false patent marking H.R. 1249, America Invents Act: reforms of the patent laws S. 23, America Invents Act: reforms of the patent laws and other provisions S. 27, Preserve Access to Affordable Generics Act: patent settlements S. 373, Fair Prescription Drug Competition Act: authorized generics International intellectual property issues Biopharmaceutical innovation policy issues
Patent Continuing Disclosure Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 243, Patent Lawsuit Reform Act of 2011: Provisions related to false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 1056, Patent Continuing Disclosure Act: Provisions related to false patent marking H.R. 1249, America Invents Act: Provisions related to patent reform H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 23, America Invents Act: Provisions related to patent reform S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics International intellectual property issues Biopharmaceutical innovation policy issues
Pill Mill Crackdown Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1065, Pill Mill Crackdown Act of 2011: prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: prescription drug abuse S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: FDA and product liability issues S. 296, Preserving Access to Life-Saving Medications Act: prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: prescription drug abuse Health care reform implementation issues including health reform fee and essential benefits General FDA advocacy Biopharmaceutical innovation policy issues
Pill Mill Crackdown Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse Health care reform implementation issues, including health reform fee and essential benefits General FDA advocacy User fee reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
Pill Mill Crackdown Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Health care reform implementation issues, including health reform fee and essential benefits General FDA related advocacy Prescription Drug User Fee Reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
Fraudulent Prescription Prevention Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1065, Pill Mill Crackdown Act of 2011: prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: prescription drug abuse S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: FDA and product liability issues S. 296, Preserving Access to Life-Saving Medications Act: prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: prescription drug abuse Health care reform implementation issues including health reform fee and essential benefits General FDA advocacy Biopharmaceutical innovation policy issues
Fraudulent Prescription Prevention Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse Health care reform implementation issues, including health reform fee and essential benefits General FDA advocacy User fee reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
Fraudulent Prescription Prevention Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Health care reform implementation issues, including health reform fee and essential benefits General FDA related advocacy Prescription Drug User Fee Reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
Drug Safety Enhancement Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Best Pharmaceuticals for Children Act (BPCA) reauthorization Pediatric Research Equity Act (PREA) reauthorization Health care reform implementation issues General HHS and FDA related advocacy Prescription Drug User Fee Act (PDUFA) reauthorization Anti-counterfeiting and supply chain issues Biopharmaceutical innovation policy issues
Ryan Creedon Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse Health care reform implementation issues, including health reform fee and essential benefits General FDA advocacy User fee reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
Ryan Creedon Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Health care reform implementation issues, including health reform fee and essential benefits General FDA related advocacy Prescription Drug User Fee Reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
Generating Antibiotic Incentives Now Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
Generating Antibiotic Incentives Now Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 243, Patent Lawsuit Reform Act of 2011: Provisions related to false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 1056, Patent Continuing Disclosure Act: Provisions related to false patent marking H.R. 1249, America Invents Act: Provisions related to patent reform H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 23, America Invents Act: Provisions related to patent reform S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics International intellectual property issues Biopharmaceutical innovation policy issues
Generating Antibiotic Incentives Now Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse Health care reform implementation issues, including health reform fee and essential benefits General FDA advocacy User fee reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
Generating Antibiotic Incentives Now Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Health care reform implementation issues, including health reform fee and essential benefits General FDA related advocacy Prescription Drug User Fee Reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
Medicare Drug Savings Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues
Medicare Drug Savings Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues
Medicare Drug Savings Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues H.R. 3765, Temporary Payroll Tax Cut Continuation Act of 2011: Provisions related to Medicare S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B and drug rebates Advocacy on Medicare/Medicaid issues being considered by the Joint Select Committee on Deficit Reduction
Preserving Access to Life-Saving Medications Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse Health care reform implementation issues, including health reform fee and essential benefits General FDA advocacy User fee reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
Preserving Access to Life-Saving Medications Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Best Pharmaceuticals for Children Act (BPCA) reauthorization Pediatric Research Equity Act (PREA) reauthorization Health care reform implementation issues General HHS and FDA related advocacy Prescription Drug User Fee Act (PDUFA) reauthorization Anti-counterfeiting and supply chain issues Biopharmaceutical innovation policy issues
Preserving Access to Life-Saving Medications Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Health care reform implementation issues, including health reform fee and essential benefits General FDA related advocacy Prescription Drug User Fee Reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
Medicare Prescription Drug Price Negotiation Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues
Medicare Prescription Drug Price Negotiation Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues H.R. 3765, Temporary Payroll Tax Cut Continuation Act of 2011: Provisions related to Medicare S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B and drug rebates Advocacy on Medicare/Medicaid issues being considered by the Joint Select Committee on Deficit Reduction
Medicare Prescription Drug Price Negotiation Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues
Patent Lawsuit Reform Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 243, Patent Lawsuit Reform Act of 2011: Provisions related to false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 1056, Patent Continuing Disclosure Act: Provisions related to false patent marking H.R. 1249, America Invents Act: Provisions related to patent reform H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 23, America Invents Act: Provisions related to patent reform S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics International intellectual property issues Biopharmaceutical innovation policy issues
Patent Lawsuit Reform Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 243, Patent Lawsuit Reform Act of 2011: false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generics H.R. 1056, Patent Continuing Disclosure Act: false patent marking H.R. 1249, America Invents Act: reforms of the patent laws S. 23, America Invents Act: reforms of the patent laws and other provisions S. 27, Preserve Access to Affordable Generics Act: patent settlements S. 373, Fair Prescription Drug Competition Act: authorized generics International intellectual property issues Biopharmaceutical innovation policy issues
Continuing Appropriations Act, 2012
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 2017, Department of Homeland Security Appropriations Act, 2012: Provisions relating to Customs and Border Protection H.R. 2112, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012: FDA related provisions H.R. 2608, Continuing Appropriations Act, 2012: FDA funding and related provisions S. 1599, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2012: HHS related provisions
Continuing Appropriations Act, 2012
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 2017, Department of Homeland Security Appropriations Act, 2012: Provisions relating to Customs and Border Protection H.R. 2112, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012: FDA related provisions H.R. 2055, Consolidated Appropriations Act, 2012: Provisions relating to health and trade H.R. 2608, Continuing Appropriations Act, 2012: FDA funding and related provisions H.R. 3671, Consolidated Appropriations Act, 2012: Provisions relating to health and trade S. 1599, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2012: HHS related provisions H.J. RES. 79, Continuing Appropriations Resolutions, 2012
Stop Online Piracy Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
Counterfeit Drug Penalty Enhancement Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
MODDERN Cures Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
Consolidated Appropriations Act, 2012
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 2017, Department of Homeland Security Appropriations Act, 2012: Provisions relating to Customs and Border Protection H.R. 2112, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012: FDA related provisions H.R. 2055, Consolidated Appropriations Act, 2012: Provisions relating to health and trade H.R. 2608, Continuing Appropriations Act, 2012: FDA funding and related provisions H.R. 3671, Consolidated Appropriations Act, 2012: Provisions relating to health and trade S. 1599, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2012: HHS related provisions H.J. RES. 79, Continuing Appropriations Resolutions, 2012
Temporary Payroll Tax Cut Continuation Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues H.R. 3765, Temporary Payroll Tax Cut Continuation Act of 2011: Provisions related to Medicare S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B and drug rebates Advocacy on Medicare/Medicaid issues being considered by the Joint Select Committee on Deficit Reduction
Medicare Decisions Accountability Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues
Medicare Decisions Accountability Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues H.R. 3765, Temporary Payroll Tax Cut Continuation Act of 2011: Provisions related to Medicare S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B and drug rebates Advocacy on Medicare/Medicaid issues being considered by the Joint Select Committee on Deficit Reduction
Medicare Decisions Accountability Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2011: exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Part D issues S. 31, Prescription Drug and Health Improvement Act of 2011: Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Part D issues S. 668, Health Care Bureaucrats Elimination Act: Independent Payment Advisory Board (IPAB) Medicaid rebate issues
Medicare Decisions Accountability Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues
Strengthening Medicare Anti-Fraud Measures Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2011: exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Part D issues S. 31, Prescription Drug and Health Improvement Act of 2011: Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Part D issues S. 668, Health Care Bureaucrats Elimination Act: Independent Payment Advisory Board (IPAB) Medicaid rebate issues
To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 243, Patent Lawsuit Reform Act of 2011: false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generics H.R. 1056, Patent Continuing Disclosure Act: false patent marking H.R. 1249, America Invents Act: reforms of the patent laws S. 23, America Invents Act: reforms of the patent laws and other provisions S. 27, Preserve Access to Affordable Generics Act: patent settlements S. 373, Fair Prescription Drug Competition Act: authorized generics International intellectual property issues Biopharmaceutical innovation policy issues
To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 243, Patent Lawsuit Reform Act of 2011: Provisions related to false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 1056, Patent Continuing Disclosure Act: Provisions related to false patent marking H.R. 1249, America Invents Act: Provisions related to patent reform H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 23, America Invents Act: Provisions related to patent reform S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics International intellectual property issues Biopharmaceutical innovation policy issues
Medicare Prescription Drug Savings and Choice Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues
Medicare Prescription Drug Savings and Choice Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues H.R. 3765, Temporary Payroll Tax Cut Continuation Act of 2011: Provisions related to Medicare S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B and drug rebates Advocacy on Medicare/Medicaid issues being considered by the Joint Select Committee on Deficit Reduction
Medicare Prescription Drug Savings and Choice Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2011: exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Part D issues S. 31, Prescription Drug and Health Improvement Act of 2011: Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Part D issues S. 668, Health Care Bureaucrats Elimination Act: Independent Payment Advisory Board (IPAB) Medicaid rebate issues
Medicare Prescription Drug Savings and Choice Act of 2011
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues
To amend title 10, United States Code, to provide police officers, criminal investigators, and game law enforcement officers of the Department of Defense with authority to execute warrants, make arrests, and carry firearms.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues
To amend title 10, United States Code, to provide police officers, criminal investigators, and game law enforcement officers of the Department of Defense with authority to execute warrants, make arrests, and carry firearms.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues
To amend title 10, United States Code, to provide police officers, criminal investigators, and game law enforcement officers of the Department of Defense with authority to execute warrants, make arrests, and carry firearms.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues H.R. 3765, Temporary Payroll Tax Cut Continuation Act of 2011: Provisions related to Medicare S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B and drug rebates Advocacy on Medicare/Medicaid issues being considered by the Joint Select Committee on Deficit Reduction
HEART for Women Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, drug labeling, access to clinical trials, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program and average manufacturer price (AMP) issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program and health reform fee issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy
HEART for Women Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2751, FDA Food Safety Modernization Act: importation H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: health reform fee issues H.R. 4994, Medicare and Medicaid Extenders Act of 2010: 340B program and other health care issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 510, FDA Food Safety Modernization Act: importation S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy Biopharmaceutical innovation policy issues
Patent Reform Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 628, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: patent pilot program H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 4954, To amend title 35, United States Code, to provide recourse under the patent law for persons who suffer competitive injury as a result of false markings: false patent marking H.R. 5980, Bring Jobs Back to America: Strategic Manufacturing & Job Repatriation Act: publication of patent applications and the economy H.R. 6352, Patent Lawsuit Reform Act of 2010: false patent marking H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 299, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: patent pilot program S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 1315, Drug Price Competition Act of 2009: 180-day exclusivity issues S. 3677, Financial Services and General Government Appropriations Act, 2011: patent settlements International intellectual property policy issues Biopharmaceutical innovation policy issues
Patent Reform Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 3677, Financial Services and General Government Appropriations Act, 2011: patent settlements International intellectual property issues
Patent Reform Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws International intellectual property issues
Patent Reform Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 3590, Patient Protection and Affordable Care Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, patent settlements, and authorized generics H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, and patent settlements S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 444, 340B Program Improvement and Integrity Act: 340B drug pricing program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B drug pricing program issues, drug labeling, access to clinical trials, and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B drug pricing program and average manufacturer price (AMP) issues H.R. 4489, Federal Employees Health Benefits Plan (FEHBP) Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B drug pricing program issues H.R. 4899, Supplemental Appropriations Act, 2010: average manufacturer price (AMP) issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues User fee issues
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, and health reform issues generally H.R. 4489, To amend chapter 89 of title 5, United States Code, to ensure program integrity, transparency, and cost savings in the pricing and contracting of prescription drug benefits under the Federal Employees Health Benefits Program: PBM transparency H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program issues, health reform fee and other heath care reform issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow-on biologics, 340B program issues, importation Health and environment issues User fee issues
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2751, FDA Food Safety Modernization Act: importation H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: health reform fee issues H.R. 4994, Medicare and Medicaid Extenders Act of 2010: 340B program and other health care issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 510, FDA Food Safety Modernization Act: importation S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy Biopharmaceutical innovation policy issues
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, drug labeling, access to clinical trials, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program and average manufacturer price (AMP) issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program and health reform fee issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy
Promoting Innovation and Access to Life-Saving Medicine Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 3590, Patient Protection and Affordable Care Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, patent settlements, and authorized generics H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, and patent settlements S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues
Promoting Innovation and Access to Life-Saving Medicine Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, and health reform issues generally H.R. 4489, To amend chapter 89 of title 5, United States Code, to ensure program integrity, transparency, and cost savings in the pricing and contracting of prescription drug benefits under the Federal Employees Health Benefits Program: PBM transparency H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program issues, health reform fee and other heath care reform issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow-on biologics, 340B program issues, importation Health and environment issues User fee issues
Pathway for Biosimilars Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, and health reform issues generally H.R. 4489, To amend chapter 89 of title 5, United States Code, to ensure program integrity, transparency, and cost savings in the pricing and contracting of prescription drug benefits under the Federal Employees Health Benefits Program: PBM transparency H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program issues, health reform fee and other heath care reform issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow-on biologics, 340B program issues, importation Health and environment issues User fee issues
Pathway for Biosimilars Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 3590, Patient Protection and Affordable Care Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, patent settlements, and authorized generics H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, and patent settlements S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues
Protecting Consumer Access to Generic Drugs Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws International intellectual property issues
Protecting Consumer Access to Generic Drugs Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 628, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: patent pilot program H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 4954, To amend title 35, United States Code, to provide recourse under the patent law for persons who suffer competitive injury as a result of false markings: false patent marking H.R. 5980, Bring Jobs Back to America: Strategic Manufacturing & Job Repatriation Act: publication of patent applications and the economy H.R. 6352, Patent Lawsuit Reform Act of 2010: false patent marking H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 299, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: patent pilot program S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 1315, Drug Price Competition Act of 2009: 180-day exclusivity issues S. 3677, Financial Services and General Government Appropriations Act, 2011: patent settlements International intellectual property policy issues Biopharmaceutical innovation policy issues
Protecting Consumer Access to Generic Drugs Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 3677, Financial Services and General Government Appropriations Act, 2011: patent settlements International intellectual property issues
Protecting Consumer Access to Generic Drugs Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 3590, Patient Protection and Affordable Care Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, patent settlements, and authorized generics H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, and patent settlements S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues
Comparative Effectiveness Research Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, and health reform issues generally H.R. 4489, To amend chapter 89 of title 5, United States Code, to ensure program integrity, transparency, and cost savings in the pricing and contracting of prescription drug benefits under the Federal Employees Health Benefits Program: PBM transparency H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program issues, health reform fee and other heath care reform issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow-on biologics, 340B program issues, importation Health and environment issues User fee issues
Comparative Effectiveness Research Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2751, FDA Food Safety Modernization Act: importation H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: health reform fee issues H.R. 4994, Medicare and Medicaid Extenders Act of 2010: 340B program and other health care issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 510, FDA Food Safety Modernization Act: importation S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy Biopharmaceutical innovation policy issues
Comparative Effectiveness Research Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 444, 340B Program Improvement and Integrity Act: 340B drug pricing program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B drug pricing program issues, drug labeling, access to clinical trials, and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B drug pricing program and average manufacturer price (AMP) issues H.R. 4489, Federal Employees Health Benefits Plan (FEHBP) Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B drug pricing program issues H.R. 4899, Supplemental Appropriations Act, 2010: average manufacturer price (AMP) issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues User fee issues
Comparative Effectiveness Research Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, drug labeling, access to clinical trials, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program and average manufacturer price (AMP) issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program and health reform fee issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy
FDA Food Safety Modernization Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2751, FDA Food Safety Modernization Act: importation H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: health reform fee issues H.R. 4994, Medicare and Medicaid Extenders Act of 2010: 340B program and other health care issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 510, FDA Food Safety Modernization Act: importation S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy Biopharmaceutical innovation policy issues
Doctor-Patient Relationship and Research Protection Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 444, 340B Program Improvement and Integrity Act: 340B drug pricing program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B drug pricing program issues, drug labeling, access to clinical trials, and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B drug pricing program and average manufacturer price (AMP) issues H.R. 4489, Federal Employees Health Benefits Plan (FEHBP) Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B drug pricing program issues H.R. 4899, Supplemental Appropriations Act, 2010: average manufacturer price (AMP) issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues User fee issues
Doctor-Patient Relationship and Research Protection Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, and health reform issues generally H.R. 4489, To amend chapter 89 of title 5, United States Code, to ensure program integrity, transparency, and cost savings in the pricing and contracting of prescription drug benefits under the Federal Employees Health Benefits Program: PBM transparency H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program issues, health reform fee and other heath care reform issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow-on biologics, 340B program issues, importation Health and environment issues User fee issues
Doctor-Patient Relationship and Research Protection Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2751, FDA Food Safety Modernization Act: importation H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: health reform fee issues H.R. 4994, Medicare and Medicaid Extenders Act of 2010: 340B program and other health care issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 510, FDA Food Safety Modernization Act: importation S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy Biopharmaceutical innovation policy issues
Doctor-Patient Relationship and Research Protection Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, drug labeling, access to clinical trials, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program and average manufacturer price (AMP) issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program and health reform fee issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy
To amend the Internal Revenue Code of 1986 to extend the research credit through 2010 and to increase and make permanent the alternative simplified research credit.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2751, FDA Food Safety Modernization Act: importation H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: health reform fee issues H.R. 4994, Medicare and Medicaid Extenders Act of 2010: 340B program and other health care issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 510, FDA Food Safety Modernization Act: importation S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy Biopharmaceutical innovation policy issues
To amend the Internal Revenue Code of 1986 to extend the research credit through 2010 and to increase and make permanent the alternative simplified research credit.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, drug labeling, access to clinical trials, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program and average manufacturer price (AMP) issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program and health reform fee issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy
340B Program Improvement and Integrity Act of 2009
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, drug labeling, access to clinical trials, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program and average manufacturer price (AMP) issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program and health reform fee issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: All provisions including Medicare Part B and 340B Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking: Provisions related to the AMP calculation, definition of line extension, and extension of the rebate to the territories Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking: Provisions related to implementation of the Sunshine reporting provisions of the Affordable Care Act Dual eligibles coordination policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
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2011 · fourth_quarter · Q4
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues H.R. 3765, Temporary Payroll Tax Cut Continuation Act of 2011: Provisions related to Medicare S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B and drug rebates Advocacy on Medicare/Medicaid issues being considered by the Joint Select Committee on Deficit Reduction
H.R. 2017, Department of Homeland Security Appropriations Act, 2012: Provisions relating to Customs and Border Protection H.R. 2112, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012: FDA related provisions H.R. 2055, Consolidated Appropriations Act, 2012: Provisions relating to health and trade H.R. 2608, Continuing Appropriations Act, 2012: FDA funding and related provisions H.R. 3671, Consolidated Appropriations Act, 2012: Provisions relating to health and trade S. 1599, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2012: HHS related provisions H.J. RES. 79, Continuing Appropriations Resolutions, 2012
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Best Pharmaceuticals for Children Act (BPCA) reauthorization Pediatric Research Equity Act (PREA) reauthorization Health care reform implementation issues General HHS and FDA related advocacy Prescription Drug User Fee Act (PDUFA) reauthorization Anti-counterfeiting and supply chain issues Biopharmaceutical innovation policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
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2011 · third_quarter · Q3
H.R. 2017, Department of Homeland Security Appropriations Act, 2012: Provisions relating to Customs and Border Protection H.R. 2112, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012: FDA related provisions H.R. 2608, Continuing Appropriations Act, 2012: FDA funding and related provisions S. 1599, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2012: HHS related provisions
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Health care reform implementation issues, including health reform fee and essential benefits General FDA related advocacy Prescription Drug User Fee Reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
Korea Free Trade Agreement: Provisions related to intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): Provisions related to intellectual property and innovation issues Issues related to Special 301 and National Trade Estimate (NTE) submissions Preference Programs International market access and intellectual property issues Biopharmaceutical innovation policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
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2011 · second_quarter · Q2
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse Health care reform implementation issues, including health reform fee and essential benefits General FDA advocacy User fee reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
H.R. 1, Full-Year Continuing Appropriations Act, 2011: Provisions relating to FDA, BARDA, Patents, USTR and NIH H.R. 1473, Department of Defense and Full-Year Continuing Appropriations Act, 2011: Provisions relating to FDA, BARDA, Patents, USTR and NIH H.R. 2017, Department of Homeland Security Appropriations Act, 2012: Provisions relating to Customs and Border Protection H.R. 2112, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012: FDA related provisions H.R. 2219, Department of Defense Appropriations Act, 2012: Provisions relating to various health accounts FY 2012 Budget Resolution: Budget for Federal agencies and programs and related authorizations and tax proposals
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues
H.R. 243, Patent Lawsuit Reform Act of 2011: Provisions related to false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 1056, Patent Continuing Disclosure Act: Provisions related to false patent marking H.R. 1249, America Invents Act: Provisions related to patent reform H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 23, America Invents Act: Provisions related to patent reform S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics International intellectual property issues Biopharmaceutical innovation policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
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2011 · first_quarter · Q1
H.R. 1, Full-Year Continuing Appropriations Act, 2011: FDA funding and related matters FY 2012 Budget Resolution: Budget for Federal agencies and programs and related authorizations and tax proposals
H.R. 1065, Pill Mill Crackdown Act of 2011: prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: prescription drug abuse S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: FDA and product liability issues S. 296, Preserving Access to Life-Saving Medications Act: prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: prescription drug abuse Health care reform implementation issues including health reform fee and essential benefits General FDA advocacy Biopharmaceutical innovation policy issues
H.R. 452, Medicare Decisions Accountability Act of 2011: Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2011: exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Part D issues S. 31, Prescription Drug and Health Improvement Act of 2011: Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Part D issues S. 668, Health Care Bureaucrats Elimination Act: Independent Payment Advisory Board (IPAB) Medicaid rebate issues
H.R. 243, Patent Lawsuit Reform Act of 2011: false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generics H.R. 1056, Patent Continuing Disclosure Act: false patent marking H.R. 1249, America Invents Act: reforms of the patent laws S. 23, America Invents Act: reforms of the patent laws and other provisions S. 27, Preserve Access to Affordable Generics Act: patent settlements S. 373, Fair Prescription Drug Competition Act: authorized generics International intellectual property issues Biopharmaceutical innovation policy issues
Filing targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
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2010 · fourth_quarter · Q4
H.R. 3082, Continuing Appropriations Amendments, 2011: FDA funding, comparative effectiveness funding, importation policy rider, Biomedical Advanced Research and Development Authority (BARDA), trade and intellectual property restrictions, patent settlements
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 628, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: patent pilot program H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 4954, To amend title 35, United States Code, to provide recourse under the patent law for persons who suffer competitive injury as a result of false markings: false patent marking H.R. 5980, Bring Jobs Back to America: Strategic Manufacturing & Job Repatriation Act: publication of patent applications and the economy H.R. 6352, Patent Lawsuit Reform Act of 2010: false patent marking H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 299, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: patent pilot program S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 1315, Drug Price Competition Act of 2009: 180-day exclusivity issues S. 3677, Financial Services and General Government Appropriations Act, 2011: patent settlements International intellectual property policy issues Biopharmaceutical innovation policy issues
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2010 · third_quarter · Q3
H.RES. 1493, Providing for budget enforcement for fiscal year 2011: budget provisions S. 3606, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2011: FDA funding
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 3677, Financial Services and General Government Appropriations Act, 2011: patent settlements International intellectual property issues
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2010 · second_quarter · Q2
H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, Part D coverage gap discounts, Part D issues generally, Medicare payment issues including the Independent Payment Advisory Board (IPAB), and Medicaid issues H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: Medicaid rebate issues H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee, and other health reform implementation issues generally H.R. 4899, Supplemental Appropriations Act, 2010: Medicaid rebate issues
H.R. 5320, The Assistance, Quality, and Affordability Act of 2010: provisions relating to a study on the presence of pharmaceuticals and personal care products in the water supply
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2010 · first_quarter · Q1
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 3590, Patient Protection and Affordable Care Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, patent settlements, and authorized generics H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, and patent settlements S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues
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2009 · fourth_quarter · Q4
H.R. 2892, Department of Homeland Security Appropriations Act, 2010: importation H.R. 2997, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding S. 1298, Department of Homeland Security Appropriations Act, 2010: importation S. 1406, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding H.R. 3288, Consolidated Appropriations Act: comparative effectiveness, NIH funding, pandemic funding
H.R. 3590, Patient Protection and Affordable Care Act: Part D coverage gap discounts, Part D rebates, Part D issues generally, Medicare payment issues, Medicaid rebate issues, transparency issues, comparative effectiveness, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: Part D coverage gap, Part D rebates, Part D issues generally, Medicaid rebate issues, transparency issues, comparative effectiveness, health reform issues generally S. 1796, Americas Healthy Future Act of 2009: Part D coverage gap discounts, Part D issues generally, Medicare payment issues, Medicaid rebate issues, comparative effectiveness, health reform fee, health reform issues generally
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2009 · third_quarter · Q3
H.R. 2847, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010: trade infringement H.R. 2892, Department of Homeland Security Appropriations Act, 2010: importation H.R. 2997, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding H.R. 3293, Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2010, and for other purposes: comparative effectiveness, NIH funding, pandemic funding S. 1298, Department of Homeland Security Appropriations Act, 2010: importation S. 1406, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding
H.R. 1145, National Water Research and Development Initiative Act of 2009: water quality issues H.R. 1191, Safe Drug Disposal Act of 2009: drug take back H.R. 1359, Secure and Responsible Drug Disposal Act of 2009: drug take back H.R. 3202, Water Protection and Reinvestment Act of 2009: water quality issues S. 1005, Water Infrastructure Financing Act: water quality issues
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2009 · second_quarter · Q2
H.R. 1, American Recovery and Reinvestment Act of 2009: comparative effectiveness H.R. 444, 340B Program Improvement and Integrity Act: issues related to 340B program (drug pricing program for covered entities) H.R. 759, Food and Drug Administration Globalization Act of 2009: import safety H.R. 1256, Family Smoking Prevention and Tobacco Control Act: importation H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 1859, Independent Drug Education and Outreach Act of 2009: academic detailing H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness House Tri-Committee Health Reform Discussion Draft S. 1, American Recovery and Reinvestment Act of 2009: comparative effectiveness S. 350, American Recovery and Reinvestment Act of 2009: comparative effectiveness S. 422, The Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: new drug application requirements S. 488, Access to Cancer Clinical Trials Act of 2009, access to clinical trials S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 717, 21st Century Cancer ALERT (Access to Life-Saving Early detection, Research and Treatment) Act: reimbursement and clinical trial issues S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 767, Independent Drug Education and Outreach Act of 2009: academic detailing S. 882, Drug and Device Accountability Act of 2009: import safety S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. __, Affordable Health Choices Act: health reform, regulatory approval pathway for follow on biologics, 340B program issues Confirmation of Kathleen Sebelius for Department of Health and Human Services Secretary Confirmation of Margaret Hamburg for Commissioner of Food and Drugs
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2009 · first_quarter · Q1
H.R. 1, American Recovery and Reinvestment Act of 2009: health care provisions including comparative effectiveness research, health information technology, and privacy issues H.R. 1105, Omnibus Appropriations Act, 2009: budget for FDA and HHS S. 1, American Recovery and Reinvestment Act of 2009: health care provisions including comparative effectiveness, health information technology, and privacy issues S. 336, American Recovery and Reinvestment Act of 2009: health care provisions including comparative effectiveness, health information technology, and privacy issues S.Con.Res.13, 2010 Budget Resolution: health care related provisions H.Con.Res. 85, 2010 Budget Resolution: health care related provisions
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 759, Food and Drug Administration Globalization Act of 2009: import safety H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act, House: regulatory approval pathway for follow-on biologics S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 717, 21st Century Cancer ALERT (Access to Life-Saving Early detection, Research and Treatment) Act: reimbursement and clinical trial issues S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 3409, Drug and Device Accountability Act of 2008: import safety Health care reform issues Confirmation of Department of Health and Human Services Secretary
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2008 · fourth_quarter · Q4
H.R. 7322, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2009: Restrictions relating to enforcement of trade agreements by the Office of the United States Trade Representative (USTR) S. 3182, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2009: Restrictions relating to enforcement of trade agreements by the Office of the United States Trade Representative (USTR) S. 3230, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2009: HHS budget, importation, comparative effectiveness, and Part D benefit issues S. 3289, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2009: FDA budget and importation issues
H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1038, Access to Life-Saving Medicine Act: follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007: follow-on biologics H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6151, Responsibility in Drug and Device Advertising Act of 2008: Direct-to-consumer drug advertising H.R. 6381, Medical Device Safety Act of 2008: preemption issues H.R. 6820, Water Assessment and Treatment Evaluation Research Study Act of 2008: pharmaceuticals in drinking water and human health S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues S. 3398, Medical Device Safety Act of 2008: preemption issues S. 3409, Drug and Device Accountability Act of 2008: import safety S. 3560, QI Program Supplemental Funding Act of 2008: antibiotic exclusivity provisions S. 3633, Transparency in Drug Labeling Act: country of origin labeling for drugs
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2008 · third_quarter · Q3
H.2638, Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009: prescription drug importation H.6947, Department of Homeland Security Appropriations Act, 2009 - Making appropriations for the Department of Homeland Security for the fiscal year ending September 30, 2009, and for other purposes: prescription drug importation S.3181, Department of Homeland Security Appropriations Act, 2009: prescription drug importation S.3182, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2009: Office of the United States Trade Representative (USTR) and related issues S.3230, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2009: HHS budget, importation, comparative effectiveness, and Part D benefit issues S.3289, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2009: FDA budget and importation issues
H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1014, Heart Disease Education, Analysis Research, and Treatment for Women Act: reporting and analysis of patient data H.R. 1038, Access to Life-Saving Medicine Act: follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007: follow-on biologics H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5501, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5683, The Government Accountability Office Act: disclosure of data H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6151, Responsibility in Drug and Device Advertising Act of 2008: direct-to-consumer drug advertising H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008: on-line pharmacy issues H.R. 6378, Strengthening of FDA Integrity Act of 2008: debarment H.R. 6381, Medical Device Safety Act of 2008: preemption issues H.R. 6388 The Government Accountability Office Improvement Act of 2008: disclosure of data H.R. 6432, Animal Drug User Fee Amendments of 2008: technical corrections to FDAAA H.R. 6820, Water Assessment and Treatment Evaluation Research Study Act of 2008: pharmaceuticals in drinking water and human health S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 2731, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues S. 3398, Medical Device Safety Act of 2008: preemption issues S. 3409, Drug and Device Accountability Act of 2008: import safety S. 3560, QI Program Supplemental Funding Act of 2008: antibiotic exclusivity provisions S. 3633, Transparency in Drug Labeling Act: country of origin labeling for drugs
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2008 · second_quarter · Q2
H.Con.Res. 312, Budget Resolution FY 2009: FDA, HHS and CMS budget issues, importation, non-interference S.Con.Res. 70, Budget Resolution FY 2009: FDA, HHS and CMS budget issues, importation, non-interference S. 3181, Making appropriations for the Department of Homeland Security for the fiscal year ending September 30, 2009, and for other purposes: importation FY'09 Agriculture Appropriations which could include FDA budget and importation issues (no bill introduced during reporting period) FY'09 Labor HHS Appropriations which could include HHS budget, importation, comparative effectiveness, and Part D benefit issues (no bill introduced during reporting period)
H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1038, Access to Life-Saving Medicine Act: follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007: follow-on biologics H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5501, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6378, Strengthening of FDA Integrity Act of 2008: debarment S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 2731, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues Food and Drug Administration Amendments Act (FDAAA) technical amendments (no bill introduced during reporting period) Pharmaceuticals in the environment issues Direct to Consumer (DTC) advertising issues Federal preemption issues
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2008 · first_quarter · Q1
H.Con.Res. 312, Budget Resolution FY 2009: FDA, HHS and CMS budget issues, importation, non-interference S.Con.Res. 70, Budget Resolution FY 2009: FDA, HHS and CMS budget issues, importation, non-interference Preparation for FY 2009 Agriculture Appropriations including FDA budget and importation issues (no bill introduced yet) Preparation for FY 2009 Labor HHS Appropriations including HHS budget, importation, comparative effectiveness, and Medicare Part D issues (no bill introduced yet) Preparation for FY 2009 Department of Homeland Security Appropriations including importation issues (no bill introduced yet)
H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1038, Access to Life-Saving Medicine Act: follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007: follow-on biologics H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5501, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health H.R. 5629, Pathway for Biosimilars Act: follow-on biologics S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health care and technology S. 2663, CPSC Reform Act: importation S. 2731, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: access and public health Measures to mitigate BSE risks related to non-ambulatory cattle Pharmaceuticals in the environment issues Anti-counterfeiting issues
African Growth and Opportunity Act Developed Country Market Access Issues Columbia Free Trade Agreement Korea Free Trade Agreement
HR 4, Medicare Prescription Drug Price Negotiation Act of 2007, Part D Benefit S. 3, Medicare Prescription Drug Price Negotiation Act of 2007, Part D Benefit
S. Con Res 21, Senate Budget Resolution, FDA & Medicare Issues H. Con Res 99, House Budget Resolution, FDA & Medicare Issues
Peru Free Trade Agreement Korea Free Trade Agreement Latin America Free Trade Agreement African Growth and Opportunity Act Developed Country Market Access Issues Latin America Free Trade Agreement Panama Free Trade Agreement
S. 1145, Patent Reform Act of 2007, patent issues HR 1908, Patent Reform Act of 2007, patent issues S. 316, Preserve Access to Affordable Generics Act, patent settlements International Intellectual Property Issues
S. 1082, Food and Drug Administration Revitalizaton Act of 2007 (Importation, Follow-on Biologics, Patent settlements, Drug Safety and PDUFA) HR. 2900, Food and Drug Administration Amendments Act of 2007 (Drug Safety and PDUFA) S. 1693, Wired for Health Care Quality Act of 2007
HR Con Res 376, House Budget Act, FDA appropriations S Con Res 83, Senate Budge Act, FDA appropriations HR 429, Budget Reconciliation Act, FDA approriations
S 3582, Preserve Access to Affordable Generics Act, patent issues HR 2795, Patent Reform Act of 2005, patent issues HR 5416, pilot program on patent cases S 2300, Lower Priced Drugs Act, patent issues S 3818, Patent Reform Act of 2006, patent issues
World Trade Orgranization issues Russia WTO Accession Korean Free Trade Agreement, intellectual property issues Peru Free Trade Agreement, intellectual property issues Columbia Free Trade Agreement, intellectual property issues
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2751, FDA Food Safety Modernization Act: importation H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: health reform fee issues H.R. 4994, Medicare and Medicaid Extenders Act of 2010: 340B program and other health care issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 510, FDA Food Safety Modernization Act: importation S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy Biopharmaceutical innovation policy issues
H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, Part D coverage gap discounts, Part D issues generally, Medicare payment issues including the Independent Payment Advisory Board (IPAB), and Medicaid issues H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee, and other health reform implementation issues generally H.R. 4994: Medicare and Medicaid Extenders Act of 2010: exclusion issues H.R. 6130 Strengthening Medicare Anti-Fraud Measures Act of 2010: exclusion issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, drug labeling, access to clinical trials, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program and average manufacturer price (AMP) issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program and health reform fee issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy
H.R. 1586, FAA Air Transportation Modernization and Safety Improvements: AMP issues H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, Part D coverage gap discounts, Part D issues generally, Medicare payment issues including the Independent Payment Advisory Board (IPAB), and Medicaid issues H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: average manufacturer price (AMP) issues H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee, and other health reform implementation issues generally H.R. 4899, Supplemental Appropriations Act, 2010: AMP issues
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 4899, Supplemental Appropriations Act, 2010: Provisions relating to the Strategic National Stockpile and disclosure of certain information by DOD contractors FY 2011 Agriculture, FDA, and Rural Development Appropriations Bill: FDA funding
H.R. 444, 340B Program Improvement and Integrity Act: 340B drug pricing program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B drug pricing program issues, drug labeling, access to clinical trials, and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B drug pricing program and average manufacturer price (AMP) issues H.R. 4489, Federal Employees Health Benefits Plan (FEHBP) Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B drug pricing program issues H.R. 4899, Supplemental Appropriations Act, 2010: average manufacturer price (AMP) issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues User fee issues
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws International intellectual property issues
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, and health reform issues generally H.R. 4489, To amend chapter 89 of title 5, United States Code, to ensure program integrity, transparency, and cost savings in the pricing and contracting of prescription drug benefits under the Federal Employees Health Benefits Program: PBM transparency H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program issues, health reform fee and other heath care reform issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow-on biologics, 340B program issues, importation Health and environment issues User fee issues
H.R. 3590, Patient Protection and Affordable Care Act: Part D coverage gap discounts, Part D rebates, Part D issues generally, Medicare payment issues, Medicaid rebate issues, transparency issues, comparative effectiveness, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: Part D coverage gap, Part D rebates, Part D issues generally, Medicaid rebate issues, transparency issues, comparative effectiveness, and health reform issues generally H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee and health reform issues generally
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 3590, Patient Protection and Affordable Care Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, patent settlements, and authorized generics H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, and patent settlements S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 1859, Independent Drug Education and Outreach Act of 2009: academic detailing H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation [S.A. 2793], health reform issues generally H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, health reform issues generally S. 422, The Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: new drug application requirements S. 488, Access to Cancer Clinical Trials Act of 2009, access to clinical trials S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 767, Independent Drug Education and Outreach Act of 2009: academic detailing S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow-on biologics, 340B program issues, importation S. 1796, Americas Healthy Future Act of 2009: comparative effectiveness, importation, health reform issues generally
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues (drug pricing program for covered entities) H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 1859, Independent Drug Education and Outreach Act of 2009: academic detailing H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3200, Americas Affordable Health Choices Act: regulatory approval pathway for follow-on biologics, 340B program issues, comparative effectiveness S. 422, The Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: new drug application requirements S. 488, Access to Cancer Clinical Trials Act of 2009, access to clinical trials S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 767, Independent Drug Education and Outreach Act of 2009: academic detailing S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow on biologics, 340B program issues Americas Healthy Future Act of 2009 Chairmans Mark Senate Finance Committee: comparative effectiveness
H.R. 684, Medicare Prescription Drug Savings and Choice Act: Part D issues H.R. 3200, Americas Affordable Health Choices Act: Medicaid rebate issues, Part D issues, health reform issues S. 301, Physician Payments Sunshine Act of 2009: transparency issues S. 330, Medicare Prescription Drug Savings and Choice Act: Part D issues S. 1110, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009: Medicare payment issues S. 1380, Medicare Payment Advisory Commission Reform Act of 2009: Medicare payment issues Americas Healthy Future Act of 2009 Chairmans Mark Senate Finance Committee: Medicaid rebate issues, Part D issues, health reform issues Senate Finance Committee options papers
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 1145, National Water Research and Development Initiative Act of 2009: water issues H.R. 1191, Safe Drug Disposal Act of 2009: drug take back H.R. 1359, Secure and Responsible Drug Disposal Act of 2009: drug take back S. 1005, Water Infrastructure Financing Act: water issues
H.R. 2346, Supplemental Appropriations Act, 2009: pandemic flu funding H.R. 2847, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010: trade infringement H.R. 2892, Department of Homeland Security Appropriations Act, 2010: importation H.R. 2997, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding S. 1298, Department of Homeland Security Appropriations Act, 2010: importation H.Con.Res. 85, 2010 Budget Resolution: health care reform funding provisions S.Con.Res.13, 2010 Budget Resolution: health care reform funding provisions Labor - Health and Human Services - Education Appropriations for Fiscal Year 2010: comparative effectiveness, NIH funding, pandemic flu funding
H.R. 1260, Patent Reform Act of 2009: patent reform issues including obtaining a patent, post-grant review, and patent litigation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements S. 299, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: establishing a pilot program for district court judges concerning patent litigation S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 515, Patent Reform Act of 2009: patent reform issues including obtaining a patent, post-grant review, and patent litigation S. 610, Patent Reform Act of 2009: patent reform issues including obtaining a patent, post-grant review, and patent litigation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues
H.R. 2, Childrens Health Insurance Program Reauthorization Act of 2009: SCHIP reauthorization, Medicaid rebate, 340B H.R. 684, Medicare Prescription Drug Savings and Choice Act: Part D issues H.R. 904, Medicaid Prescription Drug Rebate Equalization Act of 2009: managed care organization (MCO) rebate H.R. 1788, False Claims Act Correction Act of 2009: liability issues S. 275, Childrens Health Insurance Reauthorization Act of 2009: SCHIP reauthorization, Medicaid rebate S. 301, Physician Payments Sunshine Act of 2009: transparency issues S. 330, Medicare Prescription Drug Savings and Choice Act: Part D issues S. 458, False Claims Act Clarification Act of 2009: liability issues S. 1110, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009: Medicare payment issues Health care reform issues Senate Finance Committee options papers
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
S. 1145, Patent Reform Act of 2007, patent issues HR 1908, Patent Reform Act of 2007, patent issues S. 316, Preserve Access to Affordable Generics Act, patent settlements International Intellectual Property Issues
HR. 2900, Food and Drug Administration Amendments Act of 2007 (Drug Safety and PDUFA) S. 1693, Wired for Health Care Quality Act of 2007 H.R. 3610, Food and Drug Import Safety Act of 2007 (Importation) H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
S. Con Res 21, Senate Budget Resolution, FDA & Medicare Issues H. Con Res 99, House Budget Resolution, FDA & Medicare Issues
HR 4 Medicare Prescription Drug Price Negotiation Act of 2007, Part D Benefit S. 3 Medicare Prescription Drug Price Negotiation Act of 2007, Part D Benefit
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
S 3678, Pandemic and All Hazards Preparedness Act HR 5533, Biodefense and Pandemic Vaccine and Drug Development Act of 2006
HR 5970, Estate Tax and Extention of Tax Relief Act of 2006
S 1955, Health Care Modernization and Affordability Act, small business health plans HR 4157, Health Technology Promotion Act of 2006, health information technology HR 4939, Emergency Supplemental Appropriations Act, pandemic flu issues S 2766 Department of Defense Reauthorization Act, Tricare HR 5122, Department of Defense Reauthorization Act, Tricare HR 5441, Homeland Security Appropriations, Importation HR 5384, Agriculture Appropriations, Importation
Executive Branch Medicare reimbursement issues
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)