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Antibiotic Development to Advance Patient Treatment Act
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
33pct
2d open
vs 6,526 other HR bills in the 114th — cohort avg 56d
Antibiotic Development to Advance Patient Treatment Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to agree with the sponsor of an applicable medication on a process for approving the medication for use in a limited population of patients. Applicable medications are antibacterial or antifungal drugs or biological products for the treatment of a serious infection. The FDA may rely on alternate study endpoints, limited data sets, and additional data, including preclinical evidence, in approving such a medication. A medication approved for use in a limited population must be labeled accordingly. The Public Health Service Act is amended to require the Department of Health and Human Services to monitor the use of antibacterial and antifungal medications and monitor antibacterial and antifungal resistance. (An individual infected by a strain of bacteria or fungi that is resistant to a medication cannot be treated with that medication. Resistance can develop naturally with the use of a medication.) The FDA must identify and publish susceptibility test interpretive criteria for antimicrobial medications. (These criteria are used to characterize the resistance of microbes to antimicrobial medications. "Microbes" or "microorganisms" include bacteria, some fungi, and other organisms.) Every six months, the FDA must evaluate any new or updated susceptibility test interpretive criteria established by a standard development organization and recognize new criteria or withdraw recognition of criteria, as appropriate. The FDA may allow marketing of medical devices that use these criteria without premarket approval.
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Filing registrants (6)
2016 · fourth_quarter · Health Issues
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Infectious diseases (generally, no specific legislation); drug, diagnostics and vaccine R&D (generally, no specific legislation); antimicrobial resistance (generally, no specific legislation); antimicrobial stewardship (generally, no specific legislation); hospital-acquired infections (generally, no specific legislation); immunizations (generally, no specific legislation); pandemic influenza, public health security and biodefense (generally, no specific legislation); global infectious diseases (generally, no specific legislation); biomedical research (generally, no specific legislation); reauthorization of the President's Emergency Plan for AIDS Relief (PEPFAR) (generally, no specific legislation); Lyme diseases and other infectious diseases issues (generally, no specific legislation); Ryan White reauthorization (generally, no specific legislation); Prescription Drug User Fee Act (PDUFA)(generally, no specific legislation); Antibiotic Development to Advance Patient Treatment (ADAPT) Act (HR 2629); Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act (HR 512); Promise for Antibiotics and Therapeutics for Health (PATH) Act (S.185); Preventing Antibiotic Resistance Act (PARA)(S.621)
Client expense: $160,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), 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), Natl Institutes of Health (NIH), SENATE
2016 · fourth_quarter · Health Issues
Lobbying Issues Description: Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions and prescription drug abuse. Specific Legislation: 1. Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2. Implementation of the FDA Food Safety Modernization Act (Public Law 111- 353) 3. Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4. Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111- 296) 5. Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6. Implementation of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Public Law 113-5) 7. Implementation of the Drug Quality and Security Act of 2013 (Public Law 113-54) 8. Implementation of Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 9. Implementation of Child Care and Development Block Grant Act of 2014 (Public Law 113-186) 10. Promoting Health as Youth Skills in Classrooms and Life Act (S. 418) 11. National Diabetes Clinical Care Commission Act (H.R. 1192/S. 586) 12. Energy Consumers Relief Act (S. 156) 13. FIT Kids Act (S. 1075/H.R. 2013) 14. Climate Change Health Protection and Promotion Act (H.R. 1275) 15. Treat and Reduce Obesity Act (S. 1509/H.R. 2404) 16. A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings (H.R. 3660) 17. Developing a Reliable and Innovation Vision for the Economy (DRIVE) Act (S. 1647) 18. Summer Meals Act of 2014 (S. 613/H.R. 1728) 19. Long-Term SCORE Act (H.R. 282/S. 2260) 20. American Cures Act (S. 289) 21. School Food Modernization Act (S. 540) 22. Protecting Children from Electronic Cigarette Advertising Act of 2014 (S. 430/H.R. 478) 23. Bicycle and Pedestrian Infrastructure Improvement Act of 2015 (H.R. 199) 24. Waters of the United States Regulatory Overreach Protection Act of 2014 (H.R. 594) 25. Promise for Antibiotics and Therapeutics for Health Act (PATH Act, S. 185) 26. Helping Effective Antibiotics Last (HEAL) Act (H.R. 931) 27. Safe Food Act of 2015 (H.R. 609/S. 287) 28. 21st Century Cures Act (H.R. 6/H.R 34) 29. Preservation of Antibiotics for Medical Treatment Act (H.R. 1552) 30. Preventing Antibiotic Resistance Act (S. 621) 31. Healthy Families Act (H.R. 932/S. 497) 32. Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act (H.R. 512) 33. Antibiotic Development to Advance Patient Treatment Act (H.R. 2629) 34. Recognizing the importance of vaccinations and immunizations in the United States (H.Res. 117) 35. Good Samaritan Health Professionals Act (H.R. 865/S. 3101) 36. Head Start on Vaccinations Act (H.R. 933/S. 486) 37. Opioid Overdose Reduction Act (S. 707/H.R. 1821) 38. Comprehensive Addiction and Recovery Act (S. 524/H.R. 953) 39. CHIP Extension and Improvement Act of 2015 (S. 522/H.R. 919) 40. Secret Science Reform Act of 2015 (S. 544/H.R. 1030) 41. EPA Science Advisory Board Reform Act of 2015 (S. 543/H.R. 1029) 42. Medicare Access and CHIP Reauthorization Act of 2015 (H.R. 2) 43. Student Success Act (H.R. 5) 44. Every Child Achieves Act (S. 1177) 45. Sugar-Sweetened Beverages Tax (SWEET) Act (H.R. 1687) 46. Transportation Alternatives Program Improvement Act (S. 705) 47. Jason Simcakoski Memorial Opioid Safety Act (S. 1641/H.R. 4063) 48. Recovery Enhancement for Treatment (TREAT) Act (S. 1455/H.R. 2536) 49. FDA Deeming Authority Clarification Act (H.R. 2058) 50. Pathogen Reduction and Testing Reform Act (H.R. 2303) 51. Medicare Diabetes Prevention Act (S. 1131/H.R. 2102) 52. Ratepayer Protection Act (H.R. 2042) 53. Affordable Reliable Electricity Now Act (S. 1324) 54. Protecting Seniors Access to Medicare Act (H.R. 1190/S. 141) 55. Family Asthma Act (S. 1064) 56. School Asthma Management Plan Act (S. 1065) 57. Healthy Relationships Act (H.R. 453/S. 923) 58. Healthy School Meals Flexibility Act (S. 1146/H.R. 2508) 59. Reducing Federal Mandates on School Lunch Act (H.R. 1504) 60. Safe Streets Act (H.R. 2071) 61. Healthy Kids Outdoors (S. 1078/H.R. 2014) 62. Highway and Transportation Funding Act (H.R. 2353) 63. Federal Water Quality Protection Act (S. 1140) 64. Friendly Airports for Mothers Act (H.R. 2530) 65. Overdose Prevention Act (S. 2092/H.R. 4288) 66. Stop Overdose Stat Act (H.R. 2850) 67. Stop Child Summer Hunger Act (S. 1539/H.R. 2715) 68. Promoting Physical Activity for Americans Act (S. 1793/H.R. 1499) 69. Defund Planned Parenthood Act of 2015 (H.R. 3134) 70. Continuing Appropriations Act, 2016 (H.R. 719) 71. Strengthening Public Health Emergency Response Act (H.R. 3299) 72. Consolidated Appropriations Act, 2016 (Public Law 114-113) 73. Restoring Americans Healthcare Freedom Reconciliation Act of 2015 (H.R. 3762/Senate Amendment) 74. A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Corps of Engineers and the Environmental Protection Agency relating to the definition of "waters of the United States" under the Federal Water Pollution Control Act (S.J. Res 22) 75. A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of a rule submitted by the Environmental Protection Agency relating to "Standards of Performance for Greenhouse Gas Emissions from New, Modified, and Reconstructed Stationary Sources: Electric Utility Generating Units" (S.J.Res. 23) 76. On the Joint Resolution: S.J.Res. 24; A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of a rule submitted by the Environmental Protection Agency relating to "Carbon Pollution Emission Guidelines for Existing Stationary Sources: Electric Utility Generating Units" (S.J.Res 24) 77. Common Sense Nutrition Disclosure Act (H.R. 2017/S. 2217) 78. Food Labeling Modernization Act (H.R. 4061/S. 2301) 79. Fixing Americas Surface Transportation Act (Public Law 114-93) 80. Every Student Succeeds Act (Public Law 114-95) 81. Puerto Rico Assistance Act, 2015 (S. 2381) 82. Full-Service Community Schools Act, 2015 (S. 1787) 83. FY2017 Commerce, Justice, State Appropriations Act (S. 2837/H.R. 5393) 84. FY2017 Financial Services and General Government Appropriations Act (S. 3067/H.R. 5485) 85. Energy Policy Modernization Act of 2015 (S. 2012) 86. Hallways to Health Act (S. 2590/H.R. 4621) 87. GET THE LEAD OUT Act of 2016 (S. 2588) 88. CLEAR Act (S. 2587) 89. TEST KIDS Act (S. 2586) 90. FUND Water Act (S. 2583) 91. NURSE Act (S. 2572) 92. A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Corps of Engineers and the Environmental Protection Agency relating to the definition of "waters of the United States" under the Federal Water Pollution Control Act. (S.J.Res.22) 93. The Ozone Standards Implementation Act of 2016 (H.R. 4775) 94. Ozone National Ambient Air Quality Standard Deadline Harmonization Act of 2015 (H.R. 4000) 95. To repeal the Prevention and Public Health Fund (H.R. 1085) 96. Common Sense Savings Act of 2016 (H.R. 4725) 97. Establishing the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026 (H.Con.Res. 125) 98. Improving Child Nutrition Integrity and Access Act of 2016 (S. 3136) 99. Promoting Biomedical Research and Public Health for Patients Act (S. 2742) 100. Preventing Superbugs and Protecting Patients Act (S. 2503) 101. The Medical Countermeasures Innovation Act (S. 2055) 102. FY2016 Labor, Health and Human Services, and Education Appropriations Act (S. 1695/H.R. 3020) 103. FY2016 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (S. 1800/H.R. 3049/S. 2129) 104. FY 2016 Financial Services and General Government Appropriations bill, in support of an appropriation for the National Alliance for Model State Drug Laws (H.R. 2995/S. 1910/S. 2132) 105. FY2016 Congressional Budget Resolution (S.Con.Res. 11/H.Con.Res 27) 106. FY2016 Homeland Security Appropriations Act (S. 1619/H.R. 3128/S.2131) 107. FY2017 Military Construction-VA Appropriations and Zika Supplemental (H.R. 2577) 108. Public Health Emergency Preparedness Act (H.R. 4525) 109. PREPARE Act (H.R. 3583) 110. Zika Response Appropriations Act (H.R. 5243) 111. Making Supplemental Appropriations for fiscal year 2016 to respond to Zika virus (H.R. 5044) 112. A bill to provide emergency supplemental appropriations to address the Zika crisis (S. 2843) 113. FY 2017 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations Act (S. 3040) 114. FY 2017 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (S. 2956/H.R. 5054) 115. Health Equity and Accountability Act of 2016 (H.R. 5475) 116. SMASH Act (S. 3039) 117. Improving Child Nutrition and Education Act (H.R. 5003) 118. Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act (H.R. 5325) 119. Interior, Environment and Related Agencies Appropriations Bill, 2017 (S. 3068/H.R. 5538) 120. Ozone Standards Implementation Act (S. 2882) 121. National Defense Authorization Act for Fiscal Year 2017 (S. 2943) 122. Environmental Health Workforce Act of 2016 (H.R. 5543) 123. Water Resources Development Act (H.R. 5303/S. 2848) 124. Further Continuing and Security Assistance Act (Public Law 114-254)
Client expense: $40,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)
2016 · third_quarter · Health Issues
Infectious diseases (generally, no specific legislation); drug, diagnostics and vaccine R&D (generally, no specific legislation); antimicrobial resistance (generally, no specific legislation); antimicrobial stewardship (generally, no specific legislation); hospital-acquired infections (generally, no specific legislation); immunizations (generally, no specific legislation); pandemic influenza, public health security and biodefense (generally, no specific legislation); global infectious diseases (generally, no specific legislation); biomedical research (generally, no specific legislation); reauthorization of the President's Emergency Plan for AIDS Relief (PEPFAR) (generally, no specific legislation); Lyme diseases and other infectious diseases issues (generally, no specific legislation); Ryan White reauthorization (generally, no specific legislation); Prescription Drug User Fee Act (PDUFA)(generally, no specific legislation); Antibiotic Development to Advance Patient Treatment (ADAPT) Act (HR 2629); Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act (HR 512); Promise for Antibiotics and Therapeutics for Health (PATH) Act (S.185); Preventing Antibiotic Resistance Act (PARA)(S.621)
Client expense: $160,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), 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), Natl Institutes of Health (NIH), SENATE
2015 · fourth_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 683: Compassionate Access, Research Expansion, and Respect States Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2055 - the Medical Countermeasure Innovation Act of 2015 H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1321: Microbead-Free Waters Act of 2015 - Provisions related to bills applicability to prescription drugs H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 1635: Charlottes Web Medical Access Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2536: Recovery Enhancement for Addiction Treatment Act - Provisions related to the treatment of drug addiction H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2820: Stem Cell Therapeutic and Research Reauthorization Act of 2015 - Provisions related to the reauthorization of the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 2872: Opioid Addiction Treatment Modernization Act - Provisions related to the treatment of opioid addiction H.R. 3014: Medical Controlled Substances Transportation Act of 2015 - Provisions related to the transport of controlled substances by physicians in certain situations HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3680: Co-Prescribing to Reduce Overdoses Act of 2015 - Provisions related to the prescribing of opioid overdose reversal drug to at-risk patients H.R. 3762, Restoring Americans Healthcare Freedom Reconciliation Act - Provisions related to amending and withdrawing funding from the Affordable Care Act The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act issues including the Charitable Donation Exemption Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program policy issues General FDA advocacy Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy policy issues Prescription drug abuse policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner
Client expense: $380,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2015 · fourth_quarter · Health Issues
FY2016 Labor-HHS & Ed Appropriations (HR 3020/S1695) FY2016 State-Foreign Operations Appropriations legislation (HR 2772/S1725) H.R. 6, 21st Century Cures Act H.R. 2629, Antibiotic Development to Advance Patient Treatment Act S. 185, PATH ACT antibiotic development H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015
Client expense: $180,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 683: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1321: Microbead-Free Waters Act of 2015 - Provisions related to bills applicability to prescription drugs H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 1635: Charlottes Web Medical Access Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2536: Recovery Enhancement for Addiction Treatment Act - Provisions related to the treatment of drug addiction H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2820: Stem Cell Therapeutic and Research Reauthorization Act of 2015 - Provisions related to the reauthorization of the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 2872: Opioid Addiction Treatment Modernization Act - Provisions related to the treatment of opioid addiction H.R. 3014: Medical Controlled Substances Transportation Act of 2015 - Provisions related to the transport of controlled substances by physicians in certain situations H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3680: Co-Prescribing to Reduce Overdoses Act of 2015 - Provisions related to the prescribing of opioid overdose reversal drug to at-risk patients H.R. 3762, Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act issues including the Charitable Donation Exemption Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program policy issues General FDA advocacy Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy policy issues Prescription drug abuse policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner
2015 · third_quarter · Health Issues
FY2016 Labor-HHS & Ed Appropriations (HR 3020/S1695) FY2016 State-Foreign Operations Appropriations legislation (HR 2772/S1725) H.R. 6, 21st Century Cures Act H.R. 2629, Antibiotic Development to Advance Patient Treatment Act S. 185, antibiotic development H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015
Client expense: $180,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Health Issues
Funding for the Centers for Disease Control and Prevention programs, H.R. 6 - the 21st Century Cures Act and provisions related to antibiotic development and reimbursement, H.R. 2629 - Antibiotic Development to Advance Patient Treatment (ADAPT) Act: Creation of a new regulatory pathway for certain antibiotics, the Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act, H.R. 3539
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
2015 · third_quarter · Health Issues
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product HR. 3299 - the Strengthening Public Health Emergency Response Act of 20
2015 · second_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
2015 · second_quarter · Health Issues
FY2016 Labor-HHS & Ed Appropriations (HR 3020/S1695) FY2016 State-Foreign Operations Appropriations legislation (HR 2772/S1725) H.R. 6, 21st Century Cures Act H.R. 2629, Antibiotic Development to Advance Patient Treatment Act S. 185, antibiotic development
Client expense: $180,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · second_quarter · Health Issues
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product
2015 · second_quarter · Health Issues
Funding for the Centers for Disease Control and Prevention programs, Conditions of Participation for End-Stage Renal Disease facilities, H.R. 6 - the 21st Century Cures Act and provisions related to antibiotic development and reimbursement, H.R. 2629 - Antibiotic Development to Advance Patient Treatment (ADAPT) Act: Creation of a new regulatory pathway for certain antibiotics,
Client expense: $10,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Client expense: $3,820,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $4,240,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Client expense: $842,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Client expense: $4,820,000 · Firm income: Not reported
Government targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $1,123,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office