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National Biomedical Research Act
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vs 3,548 other S bills in the 114th — cohort avg 43d
National Biomedical Research Act This bill establishes and makes deposits to the Biomedical Innovation Fund for initiatives at the National Institutes of Health and the Food and Drug Administration for advancing medical innovation, including the Precision Medicine Initiative, the Brain Research through Advancing Innovative Neurotechnologies Initiative, and the Cancer Moonshot Initiative.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (14)
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 · third_quarter · Budget/Appropriations
FY18 NIH funding; FQHC funding; CDC Prevention Research Centers & REACH; Public Health Emergency Funding; National Biomedical Research Act S2624; H.R. 3770 Community Health Improvement Modernization and Excellence Act
Client expense: $20,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE
2016 · third_quarter · Budget/Appropriations
Accelerating Biomedical Research Act(S.318/ H.R.531) American Cures Act (S.289/ H.R.2104) FY2016 Agriculture Appropriations (S.1800/ H.R.3049) FY2017 Agriculture Appropriations (H.R.5054/S.2956) FY2017 Labor-HHS-Education Appropriations-provisions relating to CDC,HRSA,AHRQ, NIH,and Education(S.3040/H.R.5926) FY2017 Milcon-VA Appropriations-telestroke(S.2806/H.R.2577) FY2017 Transportation/HUD Approps (air ambulance amendment) House Energy and Commerce Committee Budget Reconciliation Instructions House/Senate Health Care Budget Reconciliation (H.R.3762) National Biomedical Research Act (S.2624) National Defense Authorization Act for FY 2017(S.2943) Research for All Act(H.R.2101) Senate Innovations Bill
Client expense: $166,728 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
Funding for federally-sponsored medical research H.R. 531/S. 318, Accelerating Biomedical Research Act - provisions related to provide stable funding to NIH S. 2624, "National Biomedical Research Act" H.R. 34, "21st Century Cures Act" - provisions related to research
Client expense: Not reported · Firm income: $110,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Science/Technology
Funding of federally-sponsored research Congressional oversight of federally-sponsored research H.R. 531/S. 318, Accelerating Biomedical Research Act - provisions to provide stable funding to NIH S. 2624, "National Biomedical Research Act" H.R. 34, "21st Century Cures Act" - provisions related to research
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
Funding for federally-sponsored medical research H.R. 531/S. 318, Accelerating Biomedical Research Act - provisions to provide stable funding to NIH S. 2624, "National Biomedical Research Act" H.R. 34, "21st Century Cures Act" - provisions related to reseach
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Democratic |
| CT |
| Michael F. Bennet | Democratic | CO |
| Patty Murray | Democratic | WA |
| Robert P. Casey, Jr. | Democratic | PA |
| Sheldon Whitehouse | Democratic | RI |
| Tammy Baldwin | Democratic | WI |
2016 · fourth_quarter · Budget/Appropriations
Presidents Budget, FY 2017 S. 3040/H.R. 5916 Labor, HHS, Education and Related Agencies Act, 2017, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), Hospital Preparedness Program, and biodefense and public health preparedness programs. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose rescissions from the Center for Medicare and Medicaid Innovation and Patient Centered Outcomes Research Trust Fund. Oppose additional continuing resolutions. President's Budget, FY 2017 Issues: Oppose proposed reductions in Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments; oppose use of Medicare GME funding for creation of new GME grant program. Oppose Independent Payment Advisory Panel (IPAB) and site-neutral payment policy. President's Budget, FY 2017 P.L. 114-223 Continuing Appropriations and Military Construction, Veterans Affairs, and Related Appropriations Act, 2017, and Zika Preparedness Act Issues: Support funding for Veterans Affairs medical research, research infrastructure, and community care. S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health (NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. S. 2624, National Biomedical Research Act. Issue: Support establishment of a Biomedical Innovation Fund to support the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Issue: Oppose Medicare payment reductions as offsets for non-Medicare spending. P.L. 114-74, H.R. 1314, Bipartisan Budget Act of 2015 Issue: Oppose Medicare site-neutral payment policy. Oppose extension of Medicare sequester Issue: Support mandatory funding for the National Health Service Corps (NHSC) authorized under P.L. 114-10, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) P.L. 114-223 Continuing Appropriations and Military Construction, Veterans Affairs, and Related Appropriations Act, 2017, and Zika Preparedness Act Issue: Support supplemental funding to prevent and combat Zika virus; Oppose use of other health funding to offset Zika investments
Client expense: $687,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
Issues related to the prevention and treatment of lung disease including the following legislation: H.R.6 21st Century Cures Act; H.R.531, Accelerating Biomedical Research Act; S.289, American Cures Act; S.318, Accelerating Biomedical Research Act; S 3040 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.5926 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.3520 Pulmonary Hypertension Research and Diagnosis Act of 2015; S.1177 Every Child Achieves Act of 2015;HR 4662 School-Based Asthma Management Program Act; S. 2624 National Biomedical Research Act; S. 2689 REGROW Act; HR 2028 Further Continuing and Security Assistance Appropriations Act, 2017; Issues related to research at the National Institutes of Health; Issues related to Moonshot Initiative; Issues related to the President's Budget; Issues related to the Budget Control Act;
Client expense: $50,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Institutes of Health (NIH), Navy, Dept of, Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · fourth_quarter · Health Issues
Issues related to the prevention and treatment of lung disease including the following legislation: H.R.6 21st Century Cures; H.R.531, Accelerating Biomedical Research Act; S.289, American Cures Act; S.318, Accelerating Biomedical Research Act; HR 1190 Protecting Seniors Access to Medicare Act of 2015; S. 1177 Every Child Achieves Act; S.1065 School Asthma Management Plan Act; S. 1064 Family Asthma Act; HR 2101 Research for All Act of 2015; S 2956 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017; HR 5054 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017; S 3040 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.5926 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; S 3000 Department of Defense Appropriations Act, 2017; HR 5293 Department of Defense Appropriations Act, 2017; S. 3117 Department of State, Foreign Operations, and Related Programs Appropriations Act, 2017; H.R.5912 Department of State, Foreign Operations, and Related Programs Appropriations Act, 2017; S 2837 Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017; HR 5393 Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017; S. 3068, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2017; H.R.5538, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2017; H.R.5394 Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2017; S. 2844 Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2017 HR 3762 Restoring Americans Healthcare Freedom Reconciliation Act of 2015; HR 3520 Pulmonary Hypertension Research and Diagnosis Act; HR 4662, School-Based Asthma Management Program Act; HR 5263, Women and Lung Cancer Research and Preventive Services Act of 2016; S.2941 - Women and Lung Cancer Research and Preventive Services Act of 2016;; HR 4662 School-Based Asthma Management Program Act; H.R. 4768, the Separation of Powers Restoration Act of 2016; HR 5263 Women and Lung Cancer Research and Preventive Services Act of 2016; S. 2624 National Biomedical Research Act; S. 2689 REGROW Act; HR 2028 Further Continuing and Security Assistance Appropriations Act, 2017; Issues related to Medicare and Medicaid reform; Issues related to Moonshot Initiative; Issues related to the Affordable Care Act; Issues related to Asthma, COPD, Influenza, Lung Cancer, Pneumonia, Tuberculosis and other lung diseases; Issues related to the President's Budget; Issues related to the Budget Control Act;
Client expense: $50,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Institutes of Health (NIH), Navy, Dept of, Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · fourth_quarter · Budget/Appropriations
Accelerating Biomedical Research Act(S.318/ H.R.531) American Cures Act (S.289/ H.R.2104) FY2017 Agriculture Appropriations (H.R.5054/S.2956) FY2017 Labor-HHS-Education Appropriations-provisions relating to CDC,HRSA,AHRQ, NIH,and Education(S.3040/H.R.5926) FY2017 Milcon-VA Appropriations-telestroke(S.2806/H.R.2577) FY2017 Transportation/HUD Approps (air ambulance amendment) House Energy and Commerce Committee Budget Reconciliation Instructions House/Senate Health Care Budget Reconciliation (H.R.3762) National Biomedical Research Act (S.2624) National Defense Authorization Act for FY 2017(S.2943) Research for All Act(H.R.2101) Senate Innovations Bill Continuing Resolution (H.R.2028)(P.L.114-254)
Client expense: $175,017 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 6, the "21st Century Cures Initiative," Section 2, funding for the Cures Innovation Fund/NIH; and, Subtitle E, "Promoting Pediatric Research Through the NIH," all provisions; Precision Medicine Initiative; S.2624, "National Biomedical Research Act," all provisions.
Client expense: $160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, 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 · Budget/Appropriations
H.R. 6 - 21st Century Cures Act S.2624 - National Biomedical Research Act S. 3084- American Innovation and Competitiveness Act General National Institutes of Health, National Science Foundation, and BRAIN Initiative FY17 budget and appropriation levels, including continuing resolution and omnibus appropriations.
Client expense: $38,818 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE
2016 · third_quarter · Medical/Disease Research/Clinical Labs
Issues related to the prevention and treatment of lung disease including the following legislation: H.R.6 21st Century Cures Act; H.R.531, Accelerating Biomedical Research Act; S.289, American Cures Act; S.318, Accelerating Biomedical Research Act; S 3040 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.5926 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.3520 Pulmonary Hypertension Research and Diagnosis Act of 2015; S.1177 Every Child Achieves Act of 2015;HR 4662 School-Based Asthma Management Program Act; S. 2624 National Biomedical Research Act; S. 2689 REGROW Act; Issues related to research at the National Institutes of Health; Issues related to Moonshot Initiative; Issues related to the President's Budget; Issues related to the Budget Control Act;
Client expense: $50,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Institutes of Health (NIH), Navy, Dept of, Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · third_quarter · Health Issues
Issues related to the prevention and treatment of lung disease including the following legislation: H.R.6 21st Century Cures; H.R.531, Accelerating Biomedical Research Act; S.289, American Cures Act; S.318, Accelerating Biomedical Research Act; HR 1190 Protecting Seniors Access to Medicare Act of 2015; S. 1177 Every Child Achieves Act; S.1065 School Asthma Management Plan Act; S. 1064 Family Asthma Act; HR 2101 Research for All Act of 2015; S 2956 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017; HR 5054 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017; S 3040 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.5926 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; S 3000 Department of Defense Appropriations Act, 2017; HR 5293 Department of Defense Appropriations Act, 2017; S. 3117 Department of State, Foreign Operations, and Related Programs Appropriations Act, 2017; H.R.5912 Department of State, Foreign Operations, and Related Programs Appropriations Act, 2017; S 2837 Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017; HR 5393 Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017; HR 2577 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2017; HR 4974 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2017; S 2806 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2017; S. 3068, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2017; H.R.5538, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2017; H.R.5394 Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2017; S. 2844 Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2017 HR 3762 Restoring Americans Healthcare Freedom Reconciliation Act of 2015; HR 3520 Pulmonary Hypertension Research and Diagnosis Act; HR 4662, School-Based Asthma Management Program Act; HR 5263, Women and Lung Cancer Research and Preventive Services Act of 2016; S.2941 - Women and Lung Cancer Research and Preventive Services Act of 2016; H.R.5325 Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act; HR 4662 School-Based Asthma Management Program Act; H.R. 4768, the Separation of Powers Restoration Act of 2016; HR 5263 Women and Lung Cancer Research and Preventive Services Act of 2016; S. 2624 National Biomedical Research Act; S. 2689 REGROW Act Issues related to Medicare and Medicaid reform; Issues related to Moonshot Initiative; Issues related to the Affordable Care Act; Issues related to Asthma, COPD, Influenza, Lung Cancer, Pneumonia, Tuberculosis and other lung diseases; Issues related to the President's Budget; Issues related to the Budget Control Act;
Client expense: $50,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Institutes of Health (NIH), Navy, Dept of, Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · third_quarter · Budget/Appropriations
S.289/ H.R.2104 - American Cures Act H.R. 6 - 21st Century Cures Act S.2624 - National Biomedical Research Act S. 318/H.R. 531 - Accelerating Biomedical Research Act S. 747/H.R. 1398 - American Innovation Act General National Institutes of Health, National Science Foundation, and BRAIN Initiative FY17 budget and appropriation levels, including continuing resolution and omnibus appropriations.
Client expense: $52,899 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE
2016 · third_quarter · Medical/Disease Research/Clinical Labs
H.R. 6, the "21st Century Cures Initiative," Section 2, funding for the Cures Innovation Fund/NIH; and, Subtitle E, "Promoting Pediatric Research Through the NIH," all provisions; Precision Medicine Initiative; S.2624, "National Biomedical Research Act," all provisions.
Client expense: $90,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, SENATE
2016 · second_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. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry 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. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) 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. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA 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. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: 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 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 - 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 - Issues related to prescription drug abuse 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. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) 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 Drug Supply Chain Security Act policy issues 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 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) negotiation and 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)
Client expense: $4,550,000 · 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), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · third_quarter · Health Issues
HR 6 21st Century Cures 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)
Client expense: $58,768 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Budget/Appropriations
Presidents Budget, FY 2017 S. 3040/H.R. 5916 Labor, HHS, Education and Related Agencies Act, 2017, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), Hospital Preparedness Program, and biodefense and public health preparedness programs. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose rescissions from the Center for Medicare and Medicaid Innovation and Patient Centered Outcomes Research Trust Fund. President's Budget, FY 2017 Issues: Oppose proposed reductions in Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments; oppose use of Medicare GME funding for creation of new GME grant program. Oppose Independent Payment Advisory Panel (IPAB) and site-neutral payment policy. President's Budget, FY 2017 P.L. 114-223 Continuing Appropriations and Military Construction, Veterans Affairs, and Related Appropriations Act, 2017, and Zika Preparedness Act Issues: Support funding for Veterans Affairs medical research, research infrastructure, and community care. S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health (NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. S. 2624, National Biomedical Research Act. Issue: Support establishment of a Biomedical Innovation Fund to support the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Issue: Oppose Medicare payment reductions as offsets for non-Medicare spending. P.L. 114-74, H.R. 1314, Bipartisan Budget Act of 2015 Issue: Oppose Medicare site-neutral payment policy. Oppose extension of Medicare sequester Issue: Support mandatory funding for the National Health Service Corps (NHSC) authorized under P.L. 114-10, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) P.L. 114-223 Continuing Appropriations and Military Construction, Veterans Affairs, and Related Appropriations Act, 2017, and Zika Preparedness Act Issue: Support supplemental funding to prevent and combat Zika virus; Oppose use of other health funding to offset Zika investments
Client expense: $595,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office
2016 · third_quarter · Budget/Appropriations
Accelerating Biomedical Research Act(S.318/ H.R.531) American Cures Act (S.289/ H.R.2104) FY2016 Agriculture Appropriations (S.1800/ H.R.3049) FY2017 Agriculture Appropriations (H.R.5054/S.2956) FY2017 Labor-HHS-Education Appropriations-provisions relating to CDC,HRSA,AHRQ, NIH,and Education(S.3040/H.R.5926) FY2017 Milcon-VA Appropriations-telestroke(S.2806/H.R.2577) FY2017 Transportation/HUD Approps (air ambulance amendment) House Energy and Commerce Committee Budget Reconciliation Instructions House/Senate Health Care Budget Reconciliation (H.R.3762) National Biomedical Research Act (S.2624) National Defense Authorization Act for FY 2017(S.2943) Research for All Act(H.R.2101) Senate Innovations Bill
Client expense: $166,728 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
2016 · third_quarter · Health Issues
S. 2742, Promoting Biomedical Research and Public Health for Patients Act, Issues related to biomedical research and reducing administrative burden. S. 2624, National Biomedical Research Act, Issues pertaining to biomedical research and funding. H.R. 6, 21st Century Cures, Issues pertaining to creation of a Senate version of medical innovation fund to provide mandatory funding to NIH and FDA.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2016 · third_quarter · Health Issues
S. 2624, National Biomedical Research Act, Issues pertaining to biomedical research and funding.
Client expense: Not reported · Firm income: $40,000
Government targets: Council on Environmental Quality (CEQ), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE
2016 · third_quarter · Health Issues
H.R. 6, 21st Century Cures, Issues relating to biomedical research. S. 2624, National Biomedical Research Act, Issues pertaining to biomedical research and funding. Issues pertaining to telehealth. Issues pertaining to concussions, TBI.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2016 · third_quarter · Medical/Disease Research/Clinical Labs
Funding for federally-sponsored medical research H.R. 531/S. 318, Accelerating Biomedical Research Act - provisions to provide stable funding to NIH S. 2624, "National Biomedical Research Act"
Client expense: Not reported · Firm income: $110,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Science/Technology
Funding of federally-sponsored research Congressional oversight of federally-sponsored research H.R. 531/S. 318, Accelerating Biomedical Research Act - provisions to provide stable funding to NIH S. 2624, "National Biomedical Research Act"
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Medical/Disease Research/Clinical Labs
Funding for federally-sponsored medical research H.R. 531/S. 318, Accelerating Biomedical Research Act - provisions to provide stable funding to NIH S. 2624, "National Biomedical Research Act"
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
H.R.5926/S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2017, Medical Center related initiatives Medical Center related initiatives Biomedical innovation legislation (Senate draft) H.R.6, 21st Century Cures Act Cancer Moonshot Initiative Monitor the following: H.R.3291, Medicare Crosswalk Hospital Code Development Act of 2015, generally H.R.3292, Medicare IME Pool Act of 2015, generally H.R.3288, Strengthening DSH and Medicare Through Subsidy Recapture and Payment Reform Act of 2015, generally H.R.4273/S.2409, Medicare and Medicaid Improvements and Adjustments Act of 2015, Medicare reimbursement issues Concussion issues, generally S.2624, National Biomedical Research Act S.320, Medical Innovation Act of 2015 S.2646, Helping Families in Mental Health Crisis Act of 2015 S.2680, Mental Health Reform Act of 2016 Public Law 114-198, Comprehensive Addiction and Recovery Act of 2016 H.R.5273, Helping Hospitals Improve Patient Care Act of 2016
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Cancer and medical research issues H.R.6, 21st Century Cures Act Biomedical innovation legislation (Senate draft) Big data issues H.R.4273/S.2409, Medicare and Medicaid Improvements and Adjustments Act of 2015, Medicare reimbursement issues Cancer Moonshot Initiative Precision Medicine Initiative S.2624, National Biomedical Research Act S.320, Medical Innovation Act of 2015
Client expense: Not reported · Firm income: $30,000
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Medical/Disease Research/Clinical Labs
H.R. 6, the "21st Century Cures Initiative," Section 2, funding for the Cures Innovation Fund/NIH; and, Subtitle E, "Promoting Pediatric Research Through the NIH," all provisions; Precision Medicine Initiative; S.2624, "National Biomedical Research Act," all provisions.
Client expense: $90,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, SENATE
2016 · second_quarter · Medical/Disease Research/Clinical Labs
H.R. 6, the "21st Century Cures Initiative," Section 2, funding for the Cures Innovation Fund/NIH; and, Subtitle E, "Promoting Pediatric Research Through the NIH," all provisions; Precision Medicine Initiative; S.2624, "National Biomedical Research Act," all provisions.
Client expense: $900,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, SENATE
2016 · second_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. 2055 - the Medical Countermeasure Innovation Act of 2015 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. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 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. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) 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. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA 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. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act S. 2912: 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 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 legitimate 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 - 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 HR. 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. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Other: - Kids Innovative Drugs Act (draft) - 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 - Drug Supply Chain Security Act policy issues - 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 - 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) negotiation and 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 - 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 sizes policy issues - House Republican Health Proposal (A Better Way)
Client expense: $1,070,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2016 · second_quarter · Budget/Appropriations
Accelerating Biomedical Research Act(S.318/ H.R.531) American Cures Act (S.289/ H.R.2104) FY2016 Agriculture Appropriations (S.1800/ H.R.3049) FY2017 Agriculture Appropriations (H.R.5054/S.2956) FY2017 Labor-HHS-Education Appropriations-provisions relating to CDC,HRSA,AHRQ, NIH,and Education(S.3040) FY2017 Milcon-VA Appropriations (telestroke) FY2017 Transportation/HUD Approps (air ambulance amendment) House Energy and Commerce Committee Budget Reconciliation Instructions House/Senate Health Care Budget Reconciliation (H.R.3762) National Biomedical Research Act (S.2624) National Defense Authorization Act for FY 2017(S.2943) Research for All Act(H.R.2101) Senate Innovations Bill
Client expense: $159,620 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
2016 · second_quarter · Budget/Appropriations
Presidents Budget, FY 2017 S.3040/draft House Labor, HHS, Education and Related Agencies Act, 2017, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), Hospital Preparedness Program, and biodefense and public health preparedness programs. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose rescissions from the Center for Medicare and Medicaid Innovation and Patient Centered Outcomes Research Trust Fund. President's Budget, FY 2017 Issues: Oppose proposed reductions in Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments; oppose use of Medicare GME funding for creation of new GME grant program. Oppose Independent Payment Advisory Panel (IPAB) and site-neutral payment policy. President's Budget, FY 2017 H.R. 2577/H.R. 4974/S. 2806 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2017 Issues: Support funding for Veterans Affairs medical research, research infrastructure, and community care. S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health (NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. S. 2624, National Biomedical Research Act. Issue: Support establishment of a Biomedical Innovation Fund to support the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Issue: Oppose Medicare payment reductions as offsets for non-Medicare spending. P.L. 114-74, H.R. 1314, Bipartisan Budget Act of 2015 Issue: Oppose Medicare site-neutral payment policy. Oppose extension of Medicare sequester Issue: Support mandatory funding for the National Health Service Corps (NHSC) authorized under P.L. 114-10, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Issue: Support supplemental funding to prevent and combat Zika virus; Oppose use of other health funding to offset Zika investments
Client expense: $736,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office
2016 · second_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. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry 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. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) 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. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA 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. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: 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 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 - 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 - Issues related to prescription drug abuse 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. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) 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 Drug Supply Chain Security Act policy issues 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 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) negotiation and 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)
Client expense: $5,820,000 · 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), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · second_quarter · Medical/Disease Research/Clinical Labs
Funding for federally-sponsored medical research H.R. 531/S. 318, Accelerating Biomedical Research Act - provisions to provide stable funding to NIH S. 2624, "National Biomedical Research Act"
Client expense: Not reported · Firm income: $110,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Science/Technology
Funding of federally-sponsored research Congressional oversight of federally-sponsored research H.R. 531/S. 318, Accelerating Biomedical Research Act - provisions to provide stable funding to NIH S. 2624, "National Biomedical Research Act"
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Medical/Disease Research/Clinical Labs
Funding for federally-sponsored medical research H.R. 531/S. 318, Accelerating Biomedical Research Act - provisions to provide stable funding to NIH S. 2624, "National Biomedical Research Act"
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research HR639 Improving Regulatory Transparency for New Medical Therapies Act (signed into law) HR 2820 Stem Cell Therapeutic and Research Reauthorization Act of 2015 (signed into law) HR 2646 S1945 Helping Families in Mental Health Crisis Act of 2015 HR 3731, S 2030 Rare Disease Fund Act of 2015 HR 3729 Limit Fetal Tissue Research S 2141 Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015 or TRUST It Act (with respect to health information technology) S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 S 2512 Adding Zika Virus to the FDA Priority Review Voucher Program Act S 1101 Medical Electronic Data Technology Enhancement for Consumers' Health Act S 1767 Combination Product Regulatory Fairness Act of 2015 S 1597 Patient-Focused Impact Assessment Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1945 Mental Health Reform Act of 2015 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 2700 FDA and NIH Workforce Authorities Modernization 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)
Client expense: $15,681 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
S. 2624, National Biomedical Research Act, Issues pertaining to biomedical research and funding.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
S. 2014, Next Generation Researchers Act, Issues related to young biomedical researchers. S. 2742, Promoting Biomedical Research and Public Health for Patients Act, Issues pertaining to biomedical research and administrative burden. S. 2624, National Biomedical Research Act, Issues pertaining to biomedical research and funding.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
S. 2624, National Biomedical Research Act, Issues pertaining to biomedical research and funding.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS)
2016 · second_quarter · Health Issues
S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2017, Medical Center related initiatives H.R.6, 21st Century Cures Act, Medical Center related initiatives Monitor the following: H.R.3291, Medicare Crosswalk Hospital Code Development Act of 2015, generally H.R.3292, Medicare IME Pool Act of 2015, generally H.R.3288, Strengthening DSH and Medicare Through Subsidy Recapture and Payment Reform Act of 2015, generally H.R.4273/S.2409, Medicare and Medicaid Improvements and Adjustments Act of 2015, Medicare reimbursement issues Concussion issues, generally S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015 S. 1622, The FDA Device Accountability Act of 2015 S. 2014, Next Generation Researchers Act S. 800, The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act S. 849, Advancing Research for Neurological Diseases Act of 2015 S. 2503, Preventing Superbugs and Protecting Patients Act S. 2511, Improving Health Information Technology 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 S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act 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.2624, National Biomedical Research Act S.320, Medical Innovation Act of 2015 S.2646, Helping Families in Mental Health Crisis Act of 2015 S.2680, Mental Health Reform Act of 2016 S.524, Comprehensive Addiction and Recovery Act of 2016 H.R.5273, Helping Hospitals Improve Patient Care Act of 2016
Client expense: Not reported · Firm income: $30,000
Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Cancer research issues H.R.6, 21st Century Cures Act, Medical research issues Big data issues H.R.4273/S.2409, Medicare and Medicaid Improvements and Adjustments Act of 2015, Medicare reimbursement issues Cancer Moonshot Initiative Precision Medicine S.2624, National Biomedical Research Act S.320, Medical Innovation Act of 2015 S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015 S. 1622, The FDA Device Accountability Act of 2015 S. 2014, Next Generation Researchers Act S. 800, The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act S. 849, Advancing Research for Neurological Diseases Act of 2015 S. 2503, Preventing Superbugs and Protecting Patients Act S. 2511, Improving Health Information Technology 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 S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act 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
Client expense: Not reported · Firm income: $30,000
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Budget/Appropriations
S.289/ H.R.2104 - American Cures Act H.R. 6 - 21st Century Cures Act S.2624 - National Biomedical Research Act S. 318/H.R. 531 - Accelerating Biomedical Research Act S. 747/H.R. 1398 - American Innovation Act General National Institutes of Health, National Science Foundation, and BRAIN Initiative FY16 budget and appropriation levels.
Client expense: $52,444 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE
2016 · first_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 2016 - Provisions related to registration under the Controlled Substances Act (CSA) S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids 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. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids 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. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055 - the Medical Countermeasure Innovation Act of 2015 S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2503: Preventing Superbugs and Protecting Patients Act - Provisions related to antibiotic development 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. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA 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 H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency 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. 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. 2745: Standard Merger and Acquisition Reviews Through Equal Rules Act of 2015; Motion to Recommit H.R. 2745 with Instructions - Provisions related to prescription drug costs 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 - 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 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. 3762: Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act H.R. 4365: Protecting Patient Access to Emergency Medications Act of 2016 - Provisions related to controlled substances 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 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 policy issues 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 including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Generic Drug User Fee Act (GDUFA) policy 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 Antibiotics development policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner Prescription drug importation policy issues Cancer Moonshot
Client expense: $1,490,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · first_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 2016 - Provisions related to registration under the Controlled Substances Act (CSA) S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids 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. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1128: Preserving Access to Orphan Drugs Act of 2013 - Provisions related to orphan drug tax (113th Congress) S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids 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. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2503: Preventing Superbugs and Protecting Patients Act - Provisions related to antibiotic development 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. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA 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 H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency 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. 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. 2745: Standard Merger and Acquisition Reviews Through Equal Rules Act of 2015; Motion to Recommit H.R. 2745 with Instructions - Provisions related to prescription drug costs 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 - 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. 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. 3762: Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act H.R. 4365: Protecting Patient Access to Emergency Medications Act of 2016 - Provisions related to controlled substances 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 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 policy issues 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 including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Generic Drug User Fee Act (GDUFA) policy 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 Antibiotics development policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner Prescription drug importation policy issues Cancer Moonshot
Client expense: $5,950,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · first_quarter · Health Issues
Medicaid program reforms, including possible regulations involving hospital outpatient departments Implementation of health care reform H.R. 546 and S. 298 (ACE Kids Act of 2015), all provisions Section 340B Drug Pricing program S.2624 (National Biomedical Research Act), entire bill FDA reform legislation generally, including H.R. 6 (21st Century Cures Act), entire bill and Senate companion legislation generally
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Medical/Disease Research/Clinical Labs
Funding for federally-sponsored medical research H.R. 531/S. 318, Accelerating Biomedical Research Act - provisions to provide stable funding to NIH S. 2624, "National Biomedical Research Act"
Client expense: Not reported · Firm income: $110,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Science/Technology
Funding of federally-sponsored research Congressional oversight of federally-sponsored research H.R. 531/S. 318, Accelerating Biomedical Research Act - provisions to provide stable funding to NIH S. 2624, "National Biomedical Research Act"
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Medical/Disease Research/Clinical Labs
Funding for federally-sponsored medical research H.R. 531/S. 318, Accelerating Biomedical Research Act - provisions to provide stable funding to NIH S. 2624, "National Biomedical Research Act"
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE