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Preserving Access to Orphan Drugs Act of 2011
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
29pct
5d open
vs 6,662 other HR bills in the 112th — cohort avg 39d
No CRS summary is available for this bill yet. The source title, actions, sponsors, and text versions below come from Congress.gov.
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Filing registrants (15)
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2013 · first_quarter · Taxation/Internal Revenue Code
H.R. 2672/S. 1423, the Preserving Access to Orphan Drugs Act of 2011: Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.Device Tax LegislationHR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act.
Client expense: $660,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Taxation/Internal Revenue Code
H.R. 2672/S. 1423, the Preserving Access to Orphan Drugs Act of 2011: Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.Device Tax LegislationHR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act.
Client expense: $820,000 · Firm income: Not reported
2012 · fourth_quarter · Pharmacy
H.R. 1409: All provisions of the Quality Health Care Coalition Act of 2011; H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733:All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare H.R. 979 - All provisions of the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 605 / S. 312 -All provisions of the Patients Freedom to Choose Act S. 27 - All provisions of the Preserve Access to Affordable Generics Act S. 31 - All provisions of the Prescription Drug and Health Improvement Act of 2011 S. 44 -All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011 H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 H.R. 1839 - All provisions of the Community Pharmacy Fairness Act of 2011; H.R. 1946 - All provisions of the Preserving or Hometown Independent Pharmacies Act of 2011; H.R. 1971 / S. 1058 - All provisions of the Pharmacy Competition and Consumer Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program H.R. 2672 the Preserving Access to Orphan Drugs Act H.R. 2182 the Generating Antibiotic Incentives Now Act H.R. 3026 the Safeguarding Americas Pharmaceuticals Act H.R. 2746 the Cancer Drug Coverage Parity Act H.R.4215 - All provisions of the Medicare Pharmacy Transparency and Fair Auditing Act
2012 · fourth_quarter · Taxation/Internal Revenue Code
H.R. 2672/S. 1423, the Preserving Access to Orphan Drugs Act of 2011: Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.Device Tax Legislation HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act.
Client expense: $820,000 · Firm income: Not reported
2012 · fourth_quarter · Health Issues
- H.R. 1249/ S. 23, "Leahy-Smith America Invents Act", issues regarding patent reform. - H.R.2672, S.1423, "Preserving Access to Orphan Drugs Act of 2011", regarding all provisions - Issues regarding PPACA implementation. - Issues regarding FDASIA implementation.
Client expense: $290,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
| Democratic |
| IN |
| Barbara Lee | Democratic | CA |
| Barney Frank | Democratic | MA |
| Brett Guthrie | Republican | KY |
| Charles B. Rangel | Democratic | NY |
| Charles W. Dent | Republican | PA |
| David B. McKinley | Republican | WV |
| Devin Nunes | Republican | CA |
| Eliot L. Engel | Democratic | NY |
| Erik Paulsen | Republican | MN |
| Gary C. Peters | Democratic | MI |
| Glenn Thompson | Republican | PA |
| James A. Himes | Democratic | CT |
| Jason Altmire | Democratic | PA |
| Kenny Marchant | Republican | TX |
| Kevin Brady | Republican | TX |
| Kurt Schrader | Democratic | OR |
| Larry Kissell | Democratic | NC |
| Loretta Sanchez | Democratic | CA |
| Lynn Jenkins | Republican | KS |
| Martin Heinrich | Democratic | NM |
| Michael C. Burgess | Republican | TX |
| Mike Kelly | Republican | PA |
| Patrick Meehan | Republican | PA |
| Paul C. Broun | Republican | GA |
| Richard E. Neal | Democratic | MA |
| Robert E. Latta | Republican | OH |
| Ron Kind | Democratic | WI |
| Ron Paul | Republican | TX |
| Russ Carnahan | Democratic | MO |
| Tim Holden | Democratic | PA |
| Tom Latham | Republican | IA |
| William L. Owens | Democratic | NY |
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $559,998 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Health Issues
Legislation to clarify the orphan drug exclusion in the annual pharmaceutical fee (S. 1423/H.R. 2672); any and all deficit reduction proposals/policies affecting plasma protein therapies; implementation of the Affordable Care Act; H.R. 1845, the IVIG Access Act
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (PREA) Drug Distribution Security (Track & Trace) HR 2672 Preserving Access to Orphan Drugs Act of 2011 S 1423 Preserving Access to Orphan Drugs Act of 2011 S. 3187 Food and Drug Administration Safety and Innovation Act Certified Importer Program S.1855, HR 2405 Pandemic and All-Hazards Preparedness Act Reauthorization of 2011
Client expense: $1,212,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
2012 · fourth_quarter · Pharmacy
Health care reform implementation, generally; Food and Drug Administration Safety and Innovation Act (PL 112-144) implementation; sequestration; drug shortages; DEA quotas for controlled substances; ADHD medication; exclusivity periods; fast track and accelerated approvals; priority vouchers; end stage renal disease Prospective Payment System (ESRD PPS); drug importation; orphan drugs; drug compounding; drug innovation and patient access; H.R. 2672, Preserving Access to Orphan Drugs Act of 2011, annual fees on orphan drugs; S. 1423, Preserving Access to Orphan Drugs Act of 2011, annual fees on orphan drugs; H.R. 8, American Taxpayer Relief Act of 2012, orphan drug tax credit; S. 481, the Federal Response to Eliminate Eating Disorders Act
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Health Issues
S. 1423/H.R. 2672, the Preserving Access to Orphan Drugs Act; Orphan Drug Designation issues; NIH grant opportunities.
Client expense: Not reported · Firm income: $70,000
Government targets: SENATE
2012 · fourth_quarter · Taxation/Internal Revenue Code
Orphan drug exclusion within the pharmaceutical tax in the Patient Protection and Affordable Care Act H.R. 2672 (Preserving Access to Orphan Drugs Act of 2011), all provisions
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · third_quarter · Health Issues
Health issues related to chronic diseases. H.R. 2672, Preserving Access to Orphan Drugs Act.
Client expense: Not reported · Firm income: Not reported
2012 · third_quarter · Medicare/Medicaid
Health issues related to chronic diseases. H.R. 2672, Preserving Access to Orphan Drugs Act.
Client expense: Not reported · Firm income: Not reported
2012 · third_quarter · Pharmacy
H.R. 1409: All provisions of the Quality Health Care Coalition Act of 2011; H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733:All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare; H.R. 979 - All provisions of the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 605 / S. 312 -All provisions of the Patients Freedom to Choose Act S. 27 - All provisions of the Preserve Access to Affordable Generics Act S. 31 - All provisions of the Prescription Drug and Health Improvement Act of 2011 S. 44 -All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011 H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 H.R. 1839 - All provisions of the Community Pharmacy Fairness Act of 2011; H.R. 1946 - All provisions of the Preserving or Hometown Independent Pharmacies Act of 2011; H.R. 1971 / S. 1058 - All provisions of the Pharmacy Competition and Consumer Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program H.R. 2672 the Preserving Access to Orphan Drugs Act H.R. 2182 the Generating Antibiotic Incentives Now Act H.R. 3026 the Safeguarding Americas Pharmaceuticals Act H.R. 2746 the Cancer Drug Coverage Parity Act H.R.4215 - All provisions of the Medicare Pharmacy Transparency and Fair Auditing Act
Client expense: $518,430 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE
2012 · third_quarter · Medicare/Medicaid
ESRD "Bundling Issues" and ESRD Drug Reimbursement Issues HCPCS Coding Decisions Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act Least Costly Alternative Policy Deficit Reduction Proposals to Joint Committee Changes re: Medicare Part B and Average Sales Price H.R. 2672/S. 1423, Preserving Access to Orphan Drugs Act Medicare Secondary Payor for ESRD Services Extension of Rebates on Medicare Part D Drugs Performance Measures for Bone and Mineral Metabolism for ESRD Program
Client expense: $400,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · third_quarter · Health Issues
Health issues related to Alzheimer's. H.R. 2672, Preserving Access to Orphan Drugs Act.
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · third_quarter · Medicare/Medicaid
Health issues related to Alzheimer's. H.R. 2672, Preserving Access to Orphan Drugs Act.
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · third_quarter · Taxation/Internal Revenue Code
H.R. 2672/S. 1423, the Preserving Access to Orphan Drugs Act of 2011: Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.Device Tax Legislation HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform.
Client expense: $460,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · third_quarter · Health Issues
- H.R. 1249/ S. 23, "Leahy-Smith America Invents Act", issues regarding patent reform. - PDUFA reauthorization - H.R.2672, S.1423, "Preserving Access to Orphan Drugs Act of 2011", regarding all provisions - Issues regarding PPACA implementation.
Client expense: $370,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), SENATE, State, Dept of (DOS)
2012 · third_quarter · Health Issues
HR 1845/ S 960 Medicare IVIG Access Act; HR 2672/ S 1423 Preserving Access to Orphan Drugs Act; HR 1919 Bleeding Disorders Screening, Awareness and Further Education Act; HR 4209 Patients' Access to Treatments Act of 2012; pharmaceutical distribution and supply chain security issues; introductory visits to member offices who represent districts where Grifols has a facility
Client expense: $350,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · third_quarter · Health Issues
Legislation to clarify the orphan drug exclusion in the annual pharmaceutical fee (S. 1423/H.R. 2672); any and all deficit reduction proposals/policies affecting plasma protein therapies; implementation of the Affordable Care Act; prescription drug user fee reauthorization
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · third_quarter · Health Issues
S. 1423/H.R. 2672, the Preserving Access to Orphan Drugs Act Prescription Drug User Fee Act Reauthorization issues Orphan Drug Designation issues NIH grant opportunities
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (PREA) Drug Distribution Security (Track & Trace) HR 2672 Preserving Access to Orphan Drugs Act of 2011 S 1423 Preserving Access to Orphan Drugs Act of 2011 S. 3187 Food and Drug Administration Safety and Innovation Act Certified Importer Program S.1855, HR 2405 Pandemic and All-Hazards Preparedness Act Reauthorization of 2011
Client expense: $1,750,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
2012 · third_quarter · Health Issues
H.R. 1845 & S. 960: Medicare IVIG Access Act H.R. 1919: Bleeding Disorder Screening, Awareness & Further Education Act H.R. 2672 / S 1423: Preserving Access to Orphan Drugs Act Introductory/Educational meetings with Congressional offices H.R. 4209: Patients Access to Treatment Act
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · third_quarter · Taxation/Internal Revenue Code
Orphan drug exclusion within the pharmaceutical tax in the Patient Protection and Affordable Care Act H.R. 2672 (Preserving Access to Orphan Drugs Act of 2011), all provisions
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · third_quarter · Health Issues
Health issues related to chronic diseases. H.R. 2672, Preserving Access to Orphan Drugs Act.
Client expense: Not reported · Firm income: Not reported
2012 · third_quarter · Medicare/Medicaid
Health issues related to chronic diseases. H.R. 2672, Preserving Access to Orphan Drugs Act.
Client expense: Not reported · Firm income: Not reported
2012 · second_quarter · Taxation/Internal Revenue Code
H.R. 2672/S. 1423, the Preserving Access to Orphan Drugs Act of 2011: Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.Device Tax Legislation HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform.
Client expense: $670,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · second_quarter · Health Issues
- H.R. 1249/ S. 23, "Leahy-Smith America Invents Act", issues regarding patent reform. - PDUFA reauthorization - H.R.2672, S.1423, "Preserving Access to Orphan Drugs Act of 2011", regarding all provisions - Issues regarding PPACA implementation.
Client expense: $320,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE, State, Dept of (DOS)
2012 · second_quarter · Health Issues
Legislation to clarify the orphan drug exclusion in the annual pharmaceutical fee (S. 1423/H.R. 2672); any and all deficit reduction proposals/policies affecting plasma protein therapies; implementation of the Affordable Care Act; prescription drug user fee reauthorization
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (RREA) Drug Distribution Security (Track & Trace) HR 2672 Preserving Access to Orphan Drugs Act of 2011 S 1423 Preserving Access to Orphan Drugs Act of 2011 S. 3187 Food and Drug Administration Safety and Innovation Act Certified Importer Program
Client expense: $1,440,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS)
2012 · second_quarter · Medicare/Medicaid
ESRD "Bundling Issues" and ESRD Drug Reimbursement Issues HCPCS Coding Decisions Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act Least Costly Alternative Policy Deficit Reduction Proposals to Joint Committee Changes re: Medicare Part B and Average Sales Price H.R. 2672/S. 1423, Preserving Access to Orphan Drugs Act Medicare Secondary Payor for ESRD Services Extension of Rebates on Medicare Part D Drugs Performance Measures for Bone and Mineral Metabolism for ESRD Program
Client expense: $360,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · second_quarter · Health Issues
HR 1845 / S 960 Medicare IVIG Access Act HR 2672 / S 1423 Preserving Access to Orphan Drugs Act HR 1919 Bleeding Disorders Screening Awareness and Further Education Act Introductory visits to member offices who represent districts where Grifols has a facility S.3187 Food and Drug Administration Safety and Innovation Act; Drug Shortages Reporting Provisions H.R.4209 Patients' Access to Treatments Act of 2012
Client expense: $350,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · second_quarter · Pharmacy
H.R. 1409: All provisions of the Quality Health Care Coalition Act of 2011; H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733:All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare; H.R. 979 - All provisions of the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 605 / S. 312 -All provisions of the Patients Freedom to Choose Act S. 27 - All provisions of the Preserve Access to Affordable Generics Act S. 31 - All provisions of the Prescription Drug and Health Improvement Act of 2011 S. 44 -All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011 H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 H.R. 1839 - All provisions of the Community Pharmacy Fairness Act of 2011; H.R. 1946 - All provisions of the Preserving or Hometown Independent Pharmacies Act of 2011; H.R. 1971 / S. 1058 - All provisions of the Pharmacy Competition and Consumer Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program H.R. 2672 the Preserving Access to Orphan Drugs Act H.R. 2182 the Generating Antibiotic Incentives Now Act H.R. 3026 the Safeguarding Americas Pharmaceuticals Act H.R. 2746 the Cancer Drug Coverage Parity Act H.R.4215 - All provisions of the Medicare Pharmacy Transparency and Fair Auditing Act
Client expense: $520,389 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE
2012 · second_quarter · Health Issues
H.R. 1845 & S. 960: Medicare IVIG Access Act H.R. 1919: Bleeding Disorder Screening, Awareness & Further Education Act H.R. 2672: Preserving Access to Orphan Drug Act Introductory/Educational meetings with Congressional offices
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · second_quarter · Health Issues
S. 1423/H.R. 2672, the Preserving Access to Orphan Drugs Act Prescription Drug User Fee Act Reauthorization issues Orphan Drug Designation issues
Client expense: Not reported · Firm income: $60,000
Government targets: SENATE
2012 · second_quarter · Taxation/Internal Revenue Code
Orphan drug exclusion within the pharmaceutical tax in the Patient Protection and Affordable Care Act H.R. 2672 (Preserving Access to Orphan Drugs Act of 2011), all provisions
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · first_quarter · Health Issues
HR 1845 / S 960 Mediare IVIG Access Act HR 2672 / S 1423 Preserving Access to Orphan Drugs Act Proposed Prescription Drug Shortage Legislation Public Health Service Pricing Program under Section 340B of the Public Health Service Act Medicaid Outpatient Prescription Drug - Average Manufacturer Price Proposed Regulations HR 1919 Bleeding Disorders Screening Awareness and Further Education Act General Legislative visits to member offices where who represent districts where Grifols has a facility
Client expense: $350,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), SENATE
2012 · first_quarter · Health Issues
HR 1845 / S 960 Mediare IVIG Access Act HR 2672 / S 1423 Preserving Access to Orphan Drugs Act Proposed Prescription Drug Shortage Legislation Public Health Service Pricing Program under Section 340B of the Public Health Service Act Medicaid Outpatient Prescription Drug - Average Manufacturer Price Proposed Regulations HR 1919 Bleeding Disorders Screening Awareness and Further Education Act General Legislative visits to member offices where who represent districts where Grifols has a facility
Client expense: Not reported · Firm income: $350,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), SENATE
2012 · first_quarter · Taxation/Internal Revenue Code
H.R. 2672/S. 1423, the Preserving Access to Orphan Drugs Act of 2011: Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.Device Tax Legislation HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation Issues related to taxation of U.S. multinational firms, corporate tax reform, and the R&D tax credit.
Client expense: $640,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)
2012 · first_quarter · Health Issues
HR 1845 / S 960 Medicare IVIG Access Act; HR 2672 / S1423 Preserving Access to Orphan Drugs Act Proposed Prescription Drug Shortage Legislation Public Health Service Pricing Program under Section 340B Medicaid Outpatient Prescription Drug/Average Manufacturer Price Proposed Rule HR 1919 Bleeding Disorder Screening Awareness and Further Education Act General Legislative visits to member offices who represent districts where Grifols has a facility
Client expense: $350,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), SENATE
2012 · first_quarter · Medicare/Medicaid
ESRD "Bundling Issues" and ESRD Drug Reimbursement Issues HCPCS Coding Decisions Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act Least Costly Alternative Policy Deficit Reduction Proposals to Joint Committee Changes re: Medicare Part B and Average Sales Price H.R. 2672/S. 1423, Preserving Access to Orphan Drugs Act Medicare Secondary Payor for ESRD Services Extension of Rebates on Medicare Part D Drugs Performance Measures for Bone and Mineral Metabolism for ESRD Program
Client expense: $375,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · first_quarter · Health Issues
HR 1845 / S 960 Medicare IVIG Access Act; HR 2672 / S 1423 Preserving Access to Orphan Drugs Act Proposed Prescription Drug Shortage Legislation Public Health Service Pricing Program under Section 340b Medicaid Outpatient Prescription Drug / Average Manufacturer Price Proposed Rule HR 1919 Bleeding Disorders Screening Awareness and Further Education Act General Legislative visits to member offices who represent districts where Grifols has a facility
Client expense: $350,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), SENATE
2012 · first_quarter · Health Issues
HR 1845 / S 960 Medicare IVIG Access Act; HR 2672 / S 1423 Preserving Access to Orphan Drugs Act Proposed Prescription Drug Shortage Legislation Public Health Service Pricing Program under Section 340B Medicaid Outpatient Prescription Drug/Average Manufacturer Price Proposed Rule HR 1919 Bleeding Disorder Screening Awareness and Further Education Act General Legislative visits to member offices who represent districts where Grifols has a facility
Client expense: $350,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), SENATE
2012 · first_quarter · Health Issues
- H.R. 1249/ S. 23, "Leahy-Smith America Invents Act", issues regarding patent reform. - PDUFA reauthorization - H.R.2672, S.1423, "Preserving Access to Orphan Drugs Act of 2011", regarding all provisions - Issues regarding PPACA implementation.
Client expense: $250,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, Treasury, Dept of
2012 · first_quarter · Pharmacy
H.R. 1409: All provisions of the Quality Health Care Coalition Act of 2011; H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733:All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare; H.R. 979 - All provisions of the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 605 / S. 312 -All provisions of the Patients Freedom to Choose Act S. 27 - All provisions of the Preserve Access to Affordable Generics Act S. 31 - All provisions of the Prescription Drug and Health Improvement Act of 2011 S. 44 -All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011 H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 H.R. 1839 - All provisions of the Community Pharmacy Fairness Act of 2011; H.R. 1946 - All provisions of the Preserving or Hometown Independent Pharmacies Act of 2011; H.R. 1971 / S. 1058 - All provisions of the Pharmacy Competition and Consumer Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program H.R. 2672 the Preserving Access to Orphan Drugs Act H.R. 2182 the Generating Antibiotic Incentives Now Act H.R. 3026 the Safeguarding Americas Pharmaceuticals Act H.R. 2746 the Cancer Drug Coverage Parity Act H.R.4215 - All provisions of the Medicare Pharmacy Transparency and Fair Auditing Act
Client expense: $519,436 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE
2012 · first_quarter · Health Issues
Legislation to clarify the orphan drug exclusion in the annual pharmaceutical fee (S. 1423/H.R. 2672); any and all deficit reduction proposals/policies affecting plasma protein therapies; implementation of the Affordable Care Act; prescription drug user fee reauthorization
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · first_quarter · Health Issues
H.R. 1845 & S. 960: Medicare IVIG Access Act H.R. 1919: Bleeding Disorder Screening, Awareness, & Further Education Act H.R. 2672: Preserving Access to Orphan Drug Act Introductory/Educational meetings with Congressional offices
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · first_quarter · Health Issues
Drug reimportation issues (S. 319); Reauthorization of Prescription Drug User Fee Act; Life sciences research tax credit legislation (Life Sciences Jobs and Investment Act--H.R.2632, S. 1410); Healthcare reform bill repeal (H.R. 2); Preserving Access to Orphan Drus Act of 2011 (H.R. 2672, S. 1423); Medicare rebates and reimbursement rates; 340B drug discount program (340B Program Improvement Act--H.R. 2674); Generic Drug and Biosimilar User Fee Act of 2012 (H.R. 3998).
Client expense: $700,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, SENATE
2012 · first_quarter · Taxation/Internal Revenue Code
Orphan drug exclusion within the pharmaceutical tax in the Patient Protection and Affordable Care Act H.R. 2672 (Preserving Access to Orphan Drugs Act of 2011), all provisions
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES
2011 · fourth_quarter · Taxation/Internal Revenue Code
H.R. 2672/S. 1423, the Preserving Access to Orphan Drugs Act of 2011: Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million
Client expense: $800,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)