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Food and Drug Administration Safety Over Sequestration Act of 2015
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Food and Drug Administration Safety Over Sequestration Act of 2015 This bill amends the Balanced Budget and Emergency Deficit Control Act of 1985 to exempt certain Food and Drug Administration user fees from sequestration. Sequestration is a process of automatic, usually across-the-board spending reductions under which budgetary resources are permanently cancelled to enforce specific budget policy goals.
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Filing registrants (19)
Referred to the House Committee on the Budget.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2016 · fourth_quarter · Budget/Appropriations
Funding for FDA and NIH Issues and policies related to FY 2017 Appropriations and all applicable amendments H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R.3762, To provide for reconciliation pursuant to section 2002 of the concurrent resolution on the budget for FY 2016 Issues and policies related to H.Con.Res. 125, House FY 2017 budget resolution and all applicable amendments
Client expense: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workforces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act S. 1878, Advancing Hope Act of 2016
2016 · fourth_quarter · Health Issues
- H 2, "Medicare Access and CHIP Reauthorization Act of 2015", regarding all provisions. - HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - S 1622, "FDA Device Accountability Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - S 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues relating to cosmetic regulatory reform. - Issues related to 340B payments to hospitals. - Issues related to pseudoephedrine. - Issues related to dextromethorphan. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - S.2977, "The Medical Electronic Data Technology Enhancement for Consumers' Health" (MEDTECH Act), regarding all provisions. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 2994, "DXM Abuse Prevention Act of 2016", regarding all provisions. - S. 1767, "The Combination Products Regulatory Fairness Act of 2015", regarding all provisions. - HR 2646, "Helping Families in Mental Health Crisis Act of 2015", regarding all provisions. - HR 1854, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - S. 1014, "Personal Care Products Safety Act", regarding all provisions. - S. 2777, "Contact lens Consumer Health Protection Act of 2016", regarding all provisions. - Issues related to Medicare Part B Demo - Issues related to Expanded Access in Senate Innovation Package - Issues related to Self monitoring of blood glucose meters. - HR 4075, "Cosmetic Modernization Amendments of 2015", regarding all provisions. - HR 1192, "National Clinical Care Commission Act", regarding all provisions.
2016 · fourth_quarter · Health Issues
H.R. 34, the 21st Century Cures Act, specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 160, the Protect Medical Innovation Act. S. 149, the Medical Device Access and Innovation Protection Act. S. 1077, the Advancing Breakthrough Devices for Patients Act. S. 1622, the FDA Device Accountability Act. S. 2737, the Improving Medical Device Innovation Act. Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the Patient Protection and Affordable Care Act, specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Policy and implementation issues relating to Public Law No. 111-148, the Patient Protection and Affordable Care Act. Policy and implementation issues relating to Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to the Prescription Drug User Fee program. Current policy issues relating to Public Law No. 110-85, the Food and Drug Administration Amendments Act, specifically FDA's Risk Evaluation and Mitigation Strategy authority. Policy issues relating to orphan drugs, dormant therapies and medicines for rare diseases; patient cost-sharing for specialty medicines; and step therapy. H.R. 34, the 21st Century Cures Act. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 2841, the Fair Access for Safe and Timely Generics Act. H.R. 1600, the Patients Access to Treatments Act. H.R. 2739, the Cancer Drug Coverage Parity Act. S. 1566, the Cancer Drug Coverage Parity Act. H.R. 3982, the Family Cord Blood Banking Act.
Client expense: Not reported · Firm income: $40,000
| Republican |
| NY |
| David G. Valadao | Republican | CA |
| Donald M. Payne, Jr. | Democratic | NJ |
| Doris O. Matsui | Democratic | CA |
| Doug LaMalfa | Republican | CA |
| Gene Green | Democratic | TX |
| Gus M. Bilirakis | Republican | FL |
| Jackie Speier | Democratic | CA |
| Jared Huffman | Democratic | CA |
| Jerry McNerney | Democratic | CA |
| John P. Sarbanes | Democratic | MD |
| Julia Brownley | Democratic | CA |
| Mark E. Amodei | Republican | NV |
| Mark Takano | Democratic | CA |
| Marsha Blackburn | Republican | TN |
| Michael C. Burgess | Republican | TX |
| Mimi Walters | Republican | CA |
| Peter Welch | Democratic | VT |
| Sam Farr | Democratic | CA |
| Scott H. Peters | Democratic | CA |
| Susan A. Davis | Democratic | CA |
| Susan W. Brooks | Republican | IN |
| Ted Lieu | Democratic | CA |
| Tony Cárdenas | Democratic | CA |
Client expense: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Client expense: $1,460,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
- H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015, regarding all provisions. - H.R. 6 - 21st Century Cures Act (P.L. 114-255), regarding all provisions. - Issues relating to cosmetic regulatory reform. - Issues related to pseudoephedrine. - Issues related Fairness to Contact Lens Consumers Act (P.L. 108-164) and related FTC Contact Lens Rule. - H.R. 3250 - DXM Abuse Prevention Act of 2015, regarding all provisions. - S. 2994 - DXM Abuse Prevention Act of 2016, regarding all provisions. - S. 1014 - Personal Care Products Safety Act of 2015, regarding all provisions. - S. 277 - Contact lens Consumer Health Protection Act of 2016, regarding all provisions. - S 697 - Frank R. Lautenberg Chemical Safety for the 21st Century Act, regarding all provisions. - H.R. 2858 - Humane Cosmetics Act, regarding all provisions.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
- H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015, regarding all provisions. - H.R. 6 - 21st Century Cures Act (P.L. 114-255), regarding all provisions. - Issues relating to cosmetic regulatory reform. - Issues related to pseudoephedrine. - Issues related Fairness to Contact Lens Consumers Act (P.L. 108-164) and related FTC Contact Lens Rule. - H.R. 3250 - DXM Abuse Prevention Act of 2015, regarding all provisions. - S. 2994 - DXM Abuse Prevention Act of 2016, regarding all provisions. - S. 1014 - Personal Care Products Safety Act of 2015, regarding all provisions. - S. 277 - Contact lens Consumer Health Protection Act of 2016, regarding all provisions. - S 697 - Frank R. Lautenberg Chemical Safety for the 21st Century Act, regarding all provisions. - H.R. 2858 - Humane Cosmetics Act, regarding all provisions.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
- H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015, regarding all provisions. - H.R. 6 - 21st Century Cures Act (P.L. 114-255), regarding all provisions. - Issues relating to cosmetic regulatory reform. - Issues related to pseudoephedrine. - Issues related Fairness to Contact Lens Consumers Act (P.L. 108-164) and related FTC Contact Lens Rule. - H.R. 3250 - DXM Abuse Prevention Act of 2015, regarding all provisions. - S. 2994 - DXM Abuse Prevention Act of 2016, regarding all provisions. - S. 1014 - Personal Care Products Safety Act of 2015, regarding all provisions. - S. 277 - Contact lens Consumer Health Protection Act of 2016, regarding all provisions. - S 697 - Frank R. Lautenberg Chemical Safety for the 21st Century Act, regarding all provisions. - H.R. 2858 - Humane Cosmetics Act, regarding all provisions.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Budget/Appropriations
H.R. 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 HR 2029 the Consolidated Appropriations Act of 2016 House and Senate agriculture and FDA appropriations acts
Client expense: $650,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Labor, Health and Human Services, Education, and Related Agencies Appropriations Bill, regarding all biopharmaceutical related provisions. Agriculture Appropriations, regarding all biopharmaceutical related provisions. H.R. 1078, FDA Safety Over Sequestration Act, regarding all biopharmaceutical related provisions. No bill, raised awareness about atrial fibrillation and stroke prevention. H/R. 1101, Viral Hepatitis Testing Act, regarding all biopharmaceutical related provisions. H.R.6 and H.R. 34, 21st Century Cures Initiative and Senate Innovation for a Healthier America proposal, regarding all biopharmaceutical related provisions. No Bill, lobbied Congress on biosimilar issues including naming, labeling and interchangeability. No Bill, lobbied Congress on importation of prescription drugs. S. 2912, Trickett Wendler Right to Try Act of 2016, S. 2912, regarding all biopharmaceutical related provisions. S. 3056, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, regarding all biopharmaceutical related provisions. No Bill, Prescription Drug User Fee Act, regarding all biopharmaceutical related provisions. No Bill, Biosimilar User Fee Act, regarding all biopharmaceutical related provisions. S. 3335/H.R. 6043 the Fair Accountability and Innovative Research Drug Pricing Act, regarding all biopharmaceutical related provisions.
Client expense: $560,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2016 · third_quarter · Budget/Appropriations
Funding for FDA and NIH Issues and policies related to FY 2017 Appropriations and all applicable amendments H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R.3762, To provide for reconciliation pursuant to section 2002 of the concurrent resolution on the budget for FY 2016 Issues and policies related to H.Con.Res. 125, House FY 2017 budget resolution and all applicable amendments
Client expense: $270,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act S. 1878, Advancing Hope Act of 2016
Client expense: $270,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
H.R. 6, the 21st Century Cures Act, specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 160, the Protect Medical Innovation Act. S. 149, the Medical Device Access and Innovation Protection Act. S. 1077, the Advancing Breakthrough Devices for Patients Act. S. 1622, the FDA Device Accountability Act. S. 2737, the Improving Medical Device Innovation Act. Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the Patient Protection and Affordable Care Act, specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Policy and implementation issues relating to Public Law No. 111-148, the Patient Protection and Affordable Care Act. Policy and implementation issues relating to Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to the Prescription Drug User Fee program. Current policy issues relating to Public Law No. 110-85, the Food and Drug Administration Amendments Act, specifically FDA's Risk Evaluation and Mitigation Strategy authority. Policy issues relating to orphan drugs, dormant therapies and medicines for rare diseases; patient cost-sharing for specialty medicines; and step therapy. H.R. 6, the 21st Century Cures Act. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 2841, the Fair Access for Safe and Timely Generics Act. H.R. 1600, the Patients Access to Treatments Act. H.R. 2739, the Cancer Drug Coverage Parity Act. S. 1566, the Cancer Drug Coverage Parity Act. H.R. 3982, the Family Cord Blood Banking Act.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
- H 2, "Medicare Access and CHIP Reauthorization Act of 2015", regarding all provisions. - HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - S 1622, "FDA Device Accountability Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - S 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues relating to cosmetic regulatory reform. - Issues related to 340B payments to hospitals. - Issues related to pseudoephedrine. - Issues related to dextromethorphan. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - S.2977, "The Medical Electronic Data Technology Enhancement for Consumers' Health" (MEDTECH Act), regarding all provisions. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 2994, "DXM Abuse Prevention Act of 2016", regarding all provisions. - S. 1767, "The Combination Products Regulatory Fairness Act of 2015", regarding all provisions. - HR 2646, "Helping Families in Mental Health Crisis Act of 2015", regarding all provisions. - HR 1854, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - S. 1014, "Personal Care Products Safety Act", regarding all provisions. - S. 277, "Contact lens Consumer Health Protection Act of 2016", regarding all provisions. - Issues related to Medicare Part B Demo - Issues related to Expanded Access in Senate Innovation Package - Issues related to Self monitoring of blood glucose meters. - HR 4075, "Cosmetic Modernization Amendments of 2015", regarding all provisions.
Client expense: $890,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · third_quarter · Budget/Appropriations
H.R. 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 HR 2029 the Consolidated Appropriations Act of 2016 House and Senate agriculture and FDA appropriations acts
Client expense: $700,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Labor, Health and Human Services, Education, and Related Agencies Appropriations Bill, regarding all biopharmaceutical related provisions. Agriculture Appropriations, regarding all biopharmaceutical related provisions. H.R. 1078, FDA Safety Over Sequestration Act, regarding all biopharmaceutical related provisions. No bill, raised awareness about atrial fibrillation and stroke prevention. H/R. 1101, Viral Hepatitis Testing Act, regarding all biopharmaceutical related provisions. H.R.6, 21st Century Cures Initiative and Senate Innovation for a Healthier America proposal, regarding all biopharmaceutical related provisions. No Bill, lobbied Congress on biosimilar issues including naming, labeling and interchangeability. No Bill, lobbied Congress on importation of prescription drugs. S. 2912, Trickett Wendler Right to Try Act of 2016, S. 2912, regarding all biopharmaceutical related provisions. S. 3056, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, regarding all biopharmaceutical related provisions. No Bill, Prescription Drug User Fee Act, regarding all biopharmaceutical related provisions. No Bill, Biosimilar User Fee Act, regarding all biopharmaceutical related provisions. S. 3335/H.R. 6043 the Fair Accountability and Innovative Research Drug Pricing Act, regarding all biopharmaceutical related provisions.
Client expense: $810,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2016 · third_quarter · Health Issues
- HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - Issues relating to cosmetic regulatory reform. - Issues related to pseudoephedrine. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 2994, "DXM Abuse Prevention Act of 2016", regarding all provisions. - S. 1014, "Personal Care Products Safety Act", regarding all provisions. - S. 277, "Contact lens Consumer Health Protection Act of 2016", regarding all provisions. - S 697, "Frank R. Lautenberg Chemical Safety for the 21st Century Act", regarding all provisions. - HR 2858, "Humane Cosmetics Act", regarding all provisions.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Budget/Appropriations
Funding for FDA and NIH Issues and policies related to FY 2017 Appropriations and all applicable amendments H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R.3762, To provide for reconciliation pursuant to section 2002 of the concurrent resolution on the budget for FY 2016 Issues and policies related to H.Con.Res. 125, House FY 2017 budget resolution and all applicable amendments
Client expense: $280,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act
Client expense: $280,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
- H 2, "Medicare Access and CHIP Reauthorization Act of 2015", regarding all provisions. - HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - S 1622, "FDA Device Accountability Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - S 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues relating to cosmetic regulatory reform. - Issues related to 340B payments to hospitals. - Issues related to pseudoephedrine. - Issues related to dextromethorphan. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - S.2977, "The Medical Electronic Data Technology Enhancement for Consumers' Health" (MEDTECH Act), regarding all provisions. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 2994, "DXM Abuse Prevention Act of 2016", regarding all provisions. - S. 1767, "The Combination Products Regulatory Fairness Act of 2015", regarding all provisions. - HR 2646, "Helping Families in Mental Health Crisis Act of 2015", regarding all provisions. - HR 1854, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - S. 1014, "Personal Care Products Safety Act", regarding all provisions. - S. 277, "Contact lens Consumer Health Protection Act of 2016", regarding all provisions. - Issues related to Medicare Part B Demo - Issues related to Expanded Access in Senate Innovation Package
Client expense: $2,040,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · second_quarter · Budget/Appropriations
H.R. 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 House and Senate agriculture and FDA appropriations acts
Client expense: $680,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Policy and implementation issues relating to Public Law No. 111-148, the "Patient Protection and Affordable Care Act." Policy and implementation issues relating to Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to the Prescription Drug User Fee program. Current policy issues relating to Public Law No. 110-85, the "Food and Drug Administration Amendments Act," specifically FDAs Risk Evaluation and Mitigation Strategy authority. Policy issues relating to orphan drugs, dormant therapies and medicines for rare diseases; patient cost-sharing for specialty medicines; and step therapy. H.R. 6, the "21st Century Cures Act. H.R. 1078, the "Food and Drug Administration Safety Over Sequestration Act." H.R. 2841, the "Fair Access for Safe and Timely Generics Act." H.R. 1600, the "Patients' Access to Treatments Act." H.R. 2739, the "Cancer Drug Coverage Parity Act." S.1566, the "Cancer Drug Coverage Parity Act." H.R. 3982, the "Family Cord Blood Banking Act."
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
H.R. 6, the "21st Century Cures Act," specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the "Food and Drug Administration Safety Over Sequestration Act." H.R. 160, the"Protect Medical Innovation Act. S. 149, the "Medical Device Access and Innovation Protection Act." S. 1077, the "Advancing Breakthrough Devices for Patients Act." S. 1622, the "FDA Device Accountability Act." S. 2737, the "Improving Medical Device Innovation Act." Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the "Patient Protection and Affordable Care Act," specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
H.R. 6, the 21st Century Cures Act, specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 160, the Protect Medical Innovation Act. S. 149, the Medical Device Access and Innovation Protection Act. S. 1077, the Advancing Breakthrough Devices for Patients Act. S. 1622, the FDA Device Accountability Act. S. 2737, the Improving Medical Device Innovation Act. Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the Patient Protection and Affordable Care Act, specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Policy and implementation issues relating to Public Law No. 111-148, the Patient Protection and Affordable Care Act. Policy and implementation issues relating to Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to the Prescription Drug User Fee program. Current policy issues relating to Public Law No. 110-85, the Food and Drug Administration Amendments Act, specifically FDA's Risk Evaluation and Mitigation Strategy authority. Policy issues relating to orphan drugs, dormant therapies and medicines for rare diseases; patient cost-sharing for specialty medicines; and step therapy. H.R. 6, the 21st Century Cures Act. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 2841, the Fair Access for Safe and Timely Generics Act. H.R. 1600, the Patients Access to Treatments Act. H.R. 2739, the Cancer Drug Coverage Parity Act. S. 1566, the Cancer Drug Coverage Parity Act. H.R. 3982, the Family Cord Blood Banking Act.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Labor, Health and Human Services, Education, and Related Agencies Appropriations Bill, regardng all biopharmaceutical related provisions. Agriculture Appropriations, regarding all biopharmaceutical related provisions. H.R. 1078, FDA Safety Over Sequestration Act, regarding all biopharmaceutical related provisions. No bill, raised awareness about atrial fibrillation and stroke prevention. H/R. 1101, Viral Hepatitis Testing Act, regarding all biopharmaceutical related provisions. H.R.6, 21st Century Cures Initiative and Senate Innovation for a Healthier America proposal, regarding all biopharmaceutical related provisions. No Bill, lobbied Congress on biosimilar issues including naming, labeling and interchangability. No Bill, lobbied Congress on importation of prescription drugs. S. 2912, Trickett Wendler Right to Try Act of 2016, S. 2912, regardng all biopharmaceutical related provisions. S. 3056, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, regardng all biopharmaceutical related provisions. No Bill, Prescription Drug User Fee Act, regardng all biopharmaceutical related provisions. No Bill, Biosimilar User Fee Act, regardng all biopharmaceutical related provisions.
Client expense: $780,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2016 · second_quarter · Health Issues
Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare program. Generally supporting intellectual property rights. Generally supporting the full repeal of the medical device excise tax. Supporting HR 1078, the FDA Safety over Sequestration Act. Supporting HR 6, the 21st Century Cures initiative, and various Senate companion bills. Opposing changes to the Medicare Part B program, specifically the Centers for Medicare & Medicaid Services (CMS) March 8, 2016 proposed rule.
Client expense: $57,378 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency
Client expense: $290,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Budget/Appropriations
Funding for FDA and NIH Issues and policies related to FY 2017 Appropriations and all applicable amendments H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R.3762, To provide for reconciliation pursuant to section 2002 of the concurrent resolution on the budget for FY 2016 Issues and policies related to H.Con.Res. 125, House FY 2017 budget resolution and all applicable amendments
Client expense: $290,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Budget/Appropriations
H.R. 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 2029 The Consolidated Appropriations Act of 2016
Client expense: $1,140,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
- H 2, "Medicare Access and CHIP Reauthorization Act of 2015", regarding all provisions. - HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - S 1622, "FDA Device Accountability Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - S 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues relating to cosmetic regulatory reform. - Issues related to 340B payments to hospitals. - Issues related to pseudoephedrine. - Issues related to dextromethorphan. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - S.2977, "The Medical Electronic Data Technology Enhancement for Consumers' Health" (MEDTECH Act), regarding all provisions. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 1767, "The Combination Products Regulatory Fairness Act of 2015", regarding all provisions. - HR 2646, "Helping Families in Mental Health Crisis Act of 2015", regarding all provisions. - HR 1854, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - S. 1014, "Personal Care Products Safety Act", regarding all provisions. - S. 277, "Contact lens Consumer Health Protection Act of 2016", regarding all provisions. - Issues related to Medicare Part B Demo - Issues related to Expanded Access in Senate Innovation Package
Client expense: $1,140,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · first_quarter · Health Issues
H.R. 6, the "21st Century Cures Act," specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 160, the Protect Medical Innovation Act. S. 149, the Medical Device Access and Innovation Protection Act. S. 1077, the "Advancing Breakthrough Devices for Patients Act." S. 1622, the "FDA Device Accountability Act." S. 2737, the "Improving Medical Device Innovation Act." Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the "Patient Protection and Affordable Care Act," specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
Policy and implementation issues relating to Public Law No. 111-148, the "Patient Protection and Affordable Care Act." Policy and implementation issues relating to Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to the Prescription Drug User Fee program. Current policy issues relating to Public Law No. 110-85, the "Food and Drug Administration Amendments Act," specifically FDAs Risk Evaluation and Mitigation Strategy authority. Policy issues relating to orphan drugs, dormant therapies and medicines for rare diseases; patient cost-sharing for specialty medicines; and step therapy. H.R. 6, the 21st Century Cures Act. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 2841, the Fair Access for Safe and Timely Generics Act. H.R. 1600, the Patients Access to Treatments Act. H.R. 2739, the Cancer Drug Coverage Parity Act. S.1566, the "Cancer Drug Coverage Parity Act." H.R. 3982, the Family Cord Blood Banking Act.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
Labor, HHS Appropriations,regarding all biopharmaceutical related provisions. Agriculture Appropriations, regarding all biopharmaceutical related provisions. H.R. 1078, FDA Safety Over Sequestration Act, regarding all biopharmaceutical related provisions. No bill, raised awareness about atrial fibrillation and stroke prevention. H/R. 1101, Viral Hepatitis Testing Act, regarding all biopharmaceutical related provisions. H.R.6, 21st Century Cures Initiative and Senate Innovation for a Healthier America proposal, regarding all biopharmaceutical related provisions. No Bill, lobbied Congress on biosimilar issues including naming, labeling and interchangability. No Bill, lobbied Congress on importation of prescription drugs.
Client expense: $690,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2016 · first_quarter · Health Issues
Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare program. Generally supporting intellectual property rights. Generally supporting the full repeal of the medical device excise tax. Supporting HR 1078, the FDA Safety over Sequestration Act. Supporting HR 6, the 21st Century Cures initiative. Opposing changes to the Medicare Part B program, specifically the Centers for Medicare & Medicaid Services (CMS) March 8, 2016 proposed rule.
Client expense: $58,477 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · second_quarter · Health Issues
Labor, HHS Appropriations,regarding all biopharmaceutical related provisions. Agriculture Appropriations, regarding all biopharmaceutical related provisions. H.R. 1078, FDA Safety Over Sequestration Act, regarding all biopharmaceutical related provisions. No bill, raised awareness about atrial fibrillation and stroke prevention. H/R. 1101, Viral Hepatitis Testing Act, regarding all biopharmaceutical related provisions. H.R.6, 21st Century Cures Initiative, regarding all biopharmaceutical related provisions.
Client expense: $670,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2015 · fourth_quarter · Budget/Appropriations
H.R. 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 2029 The Consolidated Appropriations Act of 2016
Client expense: $980,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Budget/Appropriations
FDA Funding, H.R. 1078 FDA Safety Over Sequestration Act, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2016, The Bipartisan Budget Act of 2015, Fiscal Year 2016 Omnibus Appropriations Act
Client expense: $940,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2015 · fourth_quarter · Budget/Appropriations
Funding for FDA and NIH Issues and policies related to FY 2016 Appropriations and all applicable amendments H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R.2029, Consolidated Appropriations Act, 2016 H.R.3762, Restoring Americans' Healthcare Freedom Reconciliation Act of 2015
Client expense: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues
Client expense: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
- H 2, "Medicare Access and CHIP Reauthorization Act of 2015", regarding all provisions. - HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - S 1622, "FDA Device Accountability Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - S 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues relating to cosmetic regulatory reform. - Issues related to 340B payments to hospitals. - Issues related to pseudoephedrine. - Issues related to dextromethorphan. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - S.2977, "The Medical Electronic Data Technology Enhancement for Consumers' Health" (MEDTECH Act), regarding all provisions. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 1767, "The Combination Products Regulatory Fairness Act of 2015", regarding all provisions. - S. 1622, "The FDA Devise Accountablility Act", regarding all provisions. - S. 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - HR 2646, "Helping Families in Mental Health Crisis Act of 2015", regarding all provisions. - HR 1854, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions.
Client expense: $1,210,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2015 · fourth_quarter · Budget/Appropriations
H.R. 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 2029 The Consolidated Appropriations Act of 2016
Client expense: $910,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
- H 2, "Medicare Access and CHIP Reauthorization Act of 2015", regarding all provisions. - HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - S 1622, "FDA Device Accountability Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - S 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues relating to cosmetic regulatory reform. - Issues related to 340B payments to hospitals. - Issues related to pseudoephedrine. - Issues related to dextromethorphan. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - S.2977, "The Medical Electronic Data Technology Enhancement for Consumers' Health" (MEDTECH Act), regarding all provisions. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 1767, "The Combination Products Regulatory Fairness Act of 2015", regarding all provisions. - S. 1622, "The FDA Devise Accountablility Act", regarding all provisions. - S. 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - HR 2646, "Helping Families in Mental Health Crisis Act of 2015", regarding all provisions. - HR 1854, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions.
Client expense: $1,260,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2015 · fourth_quarter · Budget/Appropriations
H.R.2029, Military Construction and Veterans Affairs and Related Agencies Appropriations Act; P.L. 114-113, Consolidated Appropriations Act, 2016 (H.R. 2029); H.R. 3762, Restoring Americans' Healthcare Freedom Reconciliation Act of 2015; Other Labor, Health and Human Services Appropriations (No Bills Introduced); H.R. 1078, Food & Drug Administration Safety Over Sequestration Act; S. 1413, FDA User Fee Protection Act; FDAs Changes Being Effected Rule;
Client expense: $1,180,000 · 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), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2015 · fourth_quarter · Health Issues
Labor, HHS Appropriations,regarding all biopharmaceutical related provisions. Agriculture Appropriations, regarding all biopharmaceutical related provisions. H.R. 1078, FDA Safety Over Sequestration Act, regarding all biopharmaceutical related provisions. No bill, raised awareness about atrial fibrillation and stroke prevention. H/R. 1101, Viral Hepatitis Testing Act, regarding all biopharmaceutical related provisions. H.R.6, 21st Century Cures Initiative and Senate Innovation for a Healthier America proposal, regarding all biopharmaceutical related provisions. No Bill, lobbied Congress on biosimilar issues including naming, labeling and interchangability.
Client expense: $780,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2015 · fourth_quarter · Health Issues
Policy and implementation issues relating to Public Law No. 111-148, the "Patient Protection and Affordable Care Act." Policy and implementation issues relating to Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to the Prescription Drug User Fee program. Current policy issues relating to Public Law No. 110-85, the "Food and Drug Administration Amendments Act," specifically FDAs Risk Evaluation and Mitigation Strategy authority. Policy issues relating to orphan drugs, dormant therapies and medicines for rare diseases. Policy issues relating to patient cost-sharing for specialty medicines. H.R. 6, the 21st Century Cures Act. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 2841, the Fair Access for Safe and Timely Generics Act. H.R. 1600, the Patients Access to Treatments Act. H.R. 2739, the Cancer Drug Coverage Parity Act. H.R. 3982, the Family Cord Blood Banking Act.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
H.R. 6, the "21st Century Cures Act," specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 160, the Protect Medical Innovation Act. S.1 49, the Medical Device Access and Innovation Protection Act. Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the "Patient Protection and Affordable Care Act," specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare program. Generally supporting intellectual property rights. Supporting HR 1078, the FDA Safety over Sequestration Act. Supporting HR 6, the House Energy and Commerce Committee's 21st Century Cures initiative Opposing HR 9, the Innovation Act (patent reform) Supporting HR 160, the Protect Medical Innovation Act (repeal of the medical device excise tax) Supporting HR 2029, the Consolidated Appropriations Act 2016
Client expense: $44,479 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Budget/Appropriations
FDA Funding, H.R. 1078 FDA Safety Over Sequestration Act, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2016, Administration budget for Fiscal Year 2017
Client expense: $870,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE