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Medical Countermeasure Innovation Act of 2016
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
90pct
179d open
vs 3,548 other S bills in the 114th — cohort avg 43d
Medical Countermeasure Innovation Act of 2016 (Sec. 2) This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to ensure the issuance of timely and accurate guidelines regarding the use of medical products for countering public health emergencies or material threats. HHS must report on funding for procurement of medical countermeasures when available funds are below a specified amount. (Sec. 3) The Biomedical Advanced Research and Development Authority's (BARDA's) contracting authority for procurement of medical countermeasures under Project BioShield is codified. (Sec. 4) The Office of the Assistant Secretary for Preparedness and Response must annually publish its budget plan for medical countermeasures. (Sec. 5) BARDA may enter an agreement with an independent, nongovernmental nonprofit to foster and accelerate the development and innovation of medical countermeasures and related technologies. BARDA must direct and oversee the nonprofit's work and ensure transparency and accountability. (Sec. 6) BARDA's procurement of medical countermeasures no longer requires Presidential approval or an agreement between HHS and the Department of Homeland Security. (Sec. 7) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to award, upon approval, a priority review voucher to the sponsor of a drug or biological product that: (1) is a significant improvement in the prevention, diagnosis, or treatment of a serious condition; and (2) can be used as a medical countermeasure to a material threat. The transferable voucher entitles the holder to have an application for a new medication acted upon by the FDA within six months. The sponsor of a medication that is subject to a voucher must pay a user fee based on the FDA's cost for the priority review process. The FDA must publish a notice each time it issues a voucher or a voucher is used. (Sec. 8) The Government Accountability Office must report on the effectiveness of this priority review voucher program in providing incentives for the development of material threat medical countermeasures.
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Filing registrants (27)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 388.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2017 · second_quarter · Medical/Disease Research/Clinical Labs
S. 2055 Medical Countermeasure Innovations Act of 2015 provision regarding priority review vouchers contracting; H.R. 34 21st Century Cures Act; H.R. 3299, Strengthening Public Health Emergency Response Act of 2016, provisions regarding priority review vouchers contracting.
Client expense: Not reported · Firm income: $20,000
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2017 · second_quarter · Health Issues
General health care coverage and reimbursement for prescription drugs; S. 2055, the Medical Countermeasure Innovation Act; regulatory issues related to biodefense vaccine development and procurement; and the Food and Drug Administration legislative and regulatory issues, including the Prescription Drug User Fee Act Re-authorization.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2017 · second_quarter · Health Issues
General health care coverage and reimbursement for prescription drugs; S. 2055, the Medical Countermeasure Innovation Act and regulatory issues related to biodefense vaccine development and procurement; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act; and the Food and Drug Administration legislative and regulatory issues.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2017 · second_quarter · Health Issues
General health care coverage and reimbursement for prescription drugs; implementation of and reforms to H.R. 3590, the Patient Protection and Affordable Care Act; S. 2055, the Medical Countermeasure Innovation Act and regulatory issues related to pandemic influenza and biodefense vaccine development and procurement; and the Food and Drug Administration legislative and regulatory issues, including the Prescription Drug User Fee Act Re-authorization.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2017 · second_quarter · Homeland Security
H.R.1300/S.1915, First Responder Anthrax Preparedness Act. H.R.3299, The Strengthening Public Health Emergency Response Act of 2015. S.2055, Medical Countermeasure Innovation Act of 2015. H.R.34, 21st Century Cures Act (P.L.114-255). Issues related to homeland security, emergency preparedness and response, and the strategic national vaccine stockpile.
Client expense: Not reported · Firm income: Not reported
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2017 · second_quarter · Health Issues
H.R.1300/S.1915, First Responder Anthrax Preparedness Act. H.R.3299, The Strengthening Public Health Emergency Response Act of 2015. S.2055, Medical Countermeasure Innovation Act of 2015. H.R.34, 21st Century Cures Act (P.L.114-255). Issues related to homeland security, emergency preparedness and response, and the strategic national vaccine stockpile.
Client expense: Not reported · Firm income: Not reported
2017 · first_quarter · Medical/Disease Research/Clinical Labs
S. 2055 Medical Countermeasure Innovations Act of 2015 provision regarding priority review vouchers contracting; H.R. 34 21st Century Cures Act; H.R. 3299, Strengthening Public Health Emergency Response Act of 2016, provisions regarding priority review vouchers contracting.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2017 · first_quarter · Health Issues
General health care coverage and reimbursement for prescription drugs; S. 2055, the Medical Countermeasure Innovation Act and regulatory issues related to biodefense vaccine development and procurement; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act; and the Food and Drug Administration legislative and regulatory issues.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2017 · first_quarter · Health Issues
General health care coverage and reimbursement for prescription drugs; S. 2055, the Medical Countermeasure Innovation Act; regulatory issues related to biodefense vaccine development and procurement; and the Food and Drug Administration legislative and regulatory issues, including the Prescription Drug User Fee Act Re-authorization.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2017 · first_quarter · Health Issues
General health care coverage and reimbursement for prescription drugs; S. 2055, the Medical Countermeasure Innovation Act and regulatory issues related to biodefense vaccine development and procurement; and the Food and Drug Administration legislative and regulatory issues.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2017 · first_quarter · Health Issues
General health care coverage and reimbursement for prescription drugs; implementation of and reforms to H.R. 3590, the Patient Protection and Affordable Care Act; S. 2055, the Medical Countermeasure Innovation Act and regulatory issues related to pandemic influenza and biodefense vaccine development and procurement; and the Food and Drug Administration legislative and regulatory issues, including the Prescription Drug User Fee Act Re-authorization.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Health Issues
Legislative & regulatory issues related to biodefense countermeasure development, including the FY17 Labor HHS Appropriations Bill. H.R. 3299, Strengthening Public Health Emergency Response Act of 2016 S. 2055, Medical Countermeasure Innovation Act of 2016; H.R. 6, 21st Century Cures Act, provisions related to medical countermeasures.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Monitor 21st Century Cures Legislation, HR 6. Consolidated and Further Continuing Appropriations Act, 2015 HR 83 S. 1878, The Advancing Hope Act of 2015 S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S. 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055, The Medical Countermeasures Innovation Act of 2015 S. 1767, The Combination Products Innovation Act of 2015 S. 1597, Patient Focused Impact Assessment Act of 2015
Client expense: Not reported · Firm income: $20,000
Government targets: Administration for Children & Families (ACF), HOUSE OF REPRESENTATIVES, 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 · 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
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
21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety
Client expense: $2,330,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR)
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
21st Century Cures/ Senate Innovation for Healthier Americans ---H.R. 34: The 21st Century Cures Act ---Longitudinal Study of Chronic Diseases Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative
Client expense: $2,330,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR)
2016 · fourth_quarter · Homeland Security
Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika
Client expense: $2,330,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR)
2016 · fourth_quarter · Medicare/Medicaid
Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Budget/Appropriations
Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
S. 2055 Medical Countermeasure Innovation Act of 2016, issues relating to Priority Review Vouchers. H.R. 6 21st Century Cures Act, issues relating to Priority Review Vouchers. H.R. 3299 Strengthening Public Health Emergency Response Act of 2015, issues relating to Priority Review Vouchers.
Client expense: $410,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)
2016 · fourth_quarter · Homeland Security
Department of Labor, Health and Human Services , Education and Related Agencies- provisions related to development, acquisition and stockpiling of biodefense vaccines. Department of Homeland Security Appropriations Act, 2017 - provisions related to development, acquisition and stockpiling of biodefense vaccines. National Defense Authorization Act for Fiscal Year 2017 - issues related to the National Biodefense Plan and chemical decontamination S. 9267 - National Biodefense Strategy H.R. 1300 - - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. S. 1915 - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. H.R. 3299 - The Strengthening Public Health Emergency Response Act of 2015 S. 2055 - Medical Countermeasure Innovation Act of 2015 H.R. 34 - 21st Century Cures
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE
2016 · fourth_quarter · Defense
Department of Labor, Health and Human Services , Education and Related Agencies- provisions related to development, acquisition and stockpiling of biodefense vaccines. Department of Homeland Security Appropriations Act, 2017 - provisions related to development, acquisition and stockpiling of biodefense vaccines. National Defense Authorization Act for Fiscal Year 2017 - issues related to the National Biodefense Plan and chemical decontamination S. 9267 - National Biodefense Strategy H.R. 1300 - - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. S. 1915 - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. H.R. 3299 - The Strengthening Public Health Emergency Response Act of 2015 S. 2055 - Medical Countermeasure Innovation Act of 2015 H.R. 34 - 21st Century Cures
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE
2016 · fourth_quarter · Budget/Appropriations
Department of Labor, Health and Human Services , Education and Related Agencies- provisions related to development, acquisition and stockpiling of biodefense vaccines. Department of Homeland Security Appropriations Act, 2017 - provisions related to development, acquisition and stockpiling of biodefense vaccines. National Defense Authorization Act for Fiscal Year 2017 - issues related to the National Biodefense Plan and chemical decontamination S. 9267 - National Biodefense Strategy H.R. 1300 - - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. S. 1915 - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. H.R. 3299 - The Strengthening Public Health Emergency Response Act of 2015 S. 2055 - Medical Countermeasure Innovation Act of 2015 H.R. 34 - 21st Century Cures
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE
2016 · fourth_quarter · Health Issues
Department of Labor, Health and Human Services , Education and Related Agencies- provisions related to development, acquisition and stockpiling of biodefense vaccines. Department of Homeland Security Appropriations Act, 2017 - provisions related to development, acquisition and stockpiling of biodefense vaccines. National Defense Authorization Act for Fiscal Year 2017 - issues related to the National Biodefense Plan and chemical decontamination S. 9267 - National Biodefense Strategy H.R. 1300 - - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. S. 1915 - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. H.R. 3299 - The Strengthening Public Health Emergency Response Act of 2015 S. 2055 - Medical Countermeasure Innovation Act of 2015 H.R. 34 - 21st Century Cures
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE
2016 · fourth_quarter · Disaster Planning/Emergencies
Department of Labor, Health and Human Services , Education and Related Agencies- provisions related to development, acquisition and stockpiling of biodefense vaccines. Department of Homeland Security Appropriations Act, 2017 - provisions related to development, acquisition and stockpiling of biodefense vaccines. National Defense Authorization Act for Fiscal Year 2017 - issues related to the National Biodefense Plan and chemical decontamination S. 9267 - National Biodefense Strategy H.R. 1300 - - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. S. 1915 - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. H.R. 3299 - The Strengthening Public Health Emergency Response Act of 2015 S. 2055 - Medical Countermeasure Innovation Act of 2015 H.R. 34 - 21st Century Cures
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE
2016 · fourth_quarter · Health Issues
Issues relating to health care H.R. 6 - 21st Century Cures Act S.2055 - Medical Countermeasure Innovation Act of 2016/H.R. 3299 - Strengthening Public Health Emergency Response Act
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), SENATE
2016 · fourth_quarter · Disaster Planning/Emergencies
Department of Labor, Health and Human Services, Education and Related Agencies Appropriations Act, 2017- provisions related to development, acquisition and stockpiling of biodefense vaccines. Department of Homeland Security Appropriations Act, 2017 - provisions related to development, acquisition and stockpiling of biodefense vaccines. Department of Defense Appropriations 2017 - provisions related to chemical decontamination and Ebola response preparedness National Defense Authorization Act for Fiscal Year 2017 - issues related to the National Biodefense Plan and chemical decontamination H.R. 1300 - - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. S 1915 - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. H.R. 3299 - The Strengthening Public Health Emergency Response Act of 2015 S 2055 - Medical Countermeasure Innovation Act of 2015 H.R. 34 - 21st Century Cures
Client expense: $420,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Homeland Security
Department of Labor, Health and Human Services,Education and Related Agencies Appropriations Act, 2017- provisions related to development, acquisition and stockpiling of biodefense vaccines. Department of Homeland Security Appropriations Act, 2017 - provisions related to development, acquisition and stockpiling of biodefense vaccines. Department of Defense Appropriations 2017 - provisions related to chemical decontamination and Ebola response preparedness National Defense Authorization Act for Fiscal Year 2017 - issues related to the National Biodefense Plan and chemical decontamination H.R. 1300 - - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. S 1915 - First Responder Anthrax Preparedness Act - directs the Secretary of Homeland Security to make anthrax vaccines and antimicrobials available to emergency response providers. H.R. 3299 - The Strengthening Public Health Emergency Response Act of 2015 S 2055 - Medical Countermeasure Innovation Act of 2015 H.R. 34 - 21st Century Cures
Client expense: $420,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R. 34, 21st Century Cures Act Priority Review Voucher program (HR 3299, S. 2055) Vaccines for first Responders (S. 1915)
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Issues related to pandemic influenza funding, federal oversight of pandemic manufacturing facilities and passage of S 2055, the Medical Countermeasure Innovation Act.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Defense
Defense Medical Innovations for Healthier Americans and S.2055, The Medical Countermeasure Innovation Act of 2016.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
S. 2055 Medical Countermeasure Innovations Act of 2015 provision regarding priority review vouchers contracting; H.R. 34 21st Century Cures Act; H.R. 3299, Strengthening Public Health Emergency Response Act of 2016, provisions regarding priority review vouchers contracting.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Health Issues
S 1077 Advancing Breakthrough Devices for Patients S2014 HR3466 Next Generation Researchers Act HR 3731, S 2030 Rare Disease Fund Act of 2015 S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1622 FDA Device Accountability Act S 849 Advancing Research for Neurological Diseases Act of 2015 S 800 Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S 2713 Advancing Precision Medicine Act of 2016 S 2745 NIH Strategic Plan and Inclusion in Clinical Research S 2472 Promoting Biomedical Research and Public Health for Patients Act (to reduce regulatory burden on NIH-funded researchers) HR 34 21st Century Cures Act (formerly HR 6), signed into law
Client expense: $38,669 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
PL 111-148 - The Patient Protection and Affordable Care Act, implementation, comparative effectiveness H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 185 - Promise for Antibiotics and Therapeutics for Health 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. 2680 - Mental Health Reform Act S. 1455 - Recovery Enhancement for Addiction Treatment Act S. 2256 - Co-Prescribing Saves Lives Act S. 480 - National All Schedules Prescription Electronic Reporting S. 2687 - Plan of Safe Care Improvement Act S. 1878 - Advancing Hope Act S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055 - Medical Countermeasures Innovation Act S. 1767 - Combination Products Innovation Act S. 1597 - Patient Focused Impact Assessment Act S. 2512 - Adding Zika Virus to FDA Priority Review Voucher Program Act S. 524 - The Comprehensive Addiction and Recovery Act of 2016 S. 2912 - Right to Try Act H.R. 34 - 21st Century Cures Act no specific bills, 340B, Innovation, A Better Way, Transparency, Precision Medicine, NIH, Importation
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Health Issues
PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation, biosimilars, 340B, disclosure, comparative effectiveness research H.R. 6 - 21st Century Cures Innovation For Healthier Americans ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, Innovation, 340B S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 185 - Promise for Antibiotics and Therapeutics for Health 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. 2680 - Mental Health Reform Act S. 1455 - Recovery Enhancement for Addiction Treatment Act S. 2256 - Co-Prescribing Saves Lives Act S. 480 - National All Schedules Prescription Electronic Reporting S. 2687 - Plan of Safe Care Improvement Act S. 1878 - Advancing Hope Act S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055 - Medical Countermeasures Innovation Act S. 1767 - Combination Products Innovation Act S. 1597 - Patient Focused Impact Assessment Act S. 2512 - Adding Zika Virus to FDA Priority Review Voucher Program Act S. 524 - The Comprehensive Addiction and Recovery Act of 2016 S. 2912 - Right to Try Act
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2016 · fourth_quarter · Disaster Planning/Emergencies
H.R. 3299: The Strengthening Public Health Emergency Response Act of 2015 S2055: Medical Countermeasure Innovation Act of 2015
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Homeland Security
H.R.1300/S.1915, First Responder Anthrax Preparedness Act. H.R.3299, The Strengthening Public Health Emergency Response Act of 2015. S.2055, Medical Countermeasure Innovation Act of 2015. H.R.34, 21st Century Cures Act (P.L.114-255). Issues related to homeland security, emergency preparedness and response, and the strategic national vaccine stockpile.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
S. 2055 Medical Countermeasure Innovation Act of 2016, issues relating to Priority Review Vouchers. H.R. 6 21st Century Cures Act, issues relating to Priority Review Vouchers. H.R. 3299 Strengthening Public Health Emergency Response Act of 2015, issues relating to Priority Review Vouchers.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · third_quarter · Health Issues
Support S. 2055, the Medical Countermeasures Innovation Act of 2016, and H.R. 3299, the Strengthening Public Health Emergency Response Act of 2015, on issues relating to Priority Review Vouchers.
Client expense: Not reported · Firm income: $50,000
Government targets: SENATE
2016 · third_quarter · Medicare/Medicaid
Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Budget/Appropriations
Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.
Client expense: $110,000 · 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
Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug user fees. Monitor legislative and administrative action related to dietary supplements. Monitor the implementation of the Patient Protection and Affordable Care Act, P.L. 111-148. Monitor legislative and administrative action related to FDAs Priority Review Voucher Program. S. 149, Medical Device Access and Innovation Protection Act. H.R. 6, 21st Century CURES Act. Senate 21st Century CURES Counterpart Package [S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511]. H.R. 160, Protect Medical Innovation Act of 2015. H.R. 1537, Advancing Hope Act of 2015.
Client expense: Not reported · Firm income: $120,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · 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 National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S.2055: Medical Countermeasure Innovation Act of 2015 S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency 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 medical research 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. 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. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST 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. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 H.R. 3299: The Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Other: - Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs - 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 - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs - 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 - 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 - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) reauthorization - Biosimilar User Fee Act (BsUFA) reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Biomarker policy issues - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial size policy issues - House Republican Health Proposal (A Better Way) - OTC Monograph Reform - Expanded access policy issues - Patient assistance program policy issues
Client expense: $640,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · third_quarter · Health Issues
S. 2055 Medical Countermeasure Innovation Act of 2016, issues relating to Priority Review Vouchers. H.R. 6 21st Century Cures Act, issues relating to Priority Review Vouchers. H.R. 3299 Strengthening Public Health Emergency Response Act of 2015, issues relating to Priority Review Vouchers.
Client expense: $380,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)
2016 · third_quarter · Homeland Security
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika
Client expense: $2,330,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of Technology Policy (OTP), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · third_quarter · Health Issues
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Evaluation and Review ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---FDA Proposed Rule on Changes to Drug Labeling ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Government Price Reporting ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Senate Innovation for Healthier Americans ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Client expense: $2,330,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of Technology Policy (OTP), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.