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Legislative Progress
Introduced
December 14, 2021
Latest Action
December 14, 2021
Primary Sponsor
Margaret Wood HassanDemocratic(NH)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 5,357 other S bills in the 117th — cohort avg 38d
Emergency Use Transparency Act This bill expands existing statutory provisions requiring the Food and Drug Administration (FDA) to publish notices of authorizations, terminations, or revocations of emergency use authorizations for medical products. Specifically, the bill requires the FDA to publish such notices on its website. The bill also allows the FDA's disclosures to include a summary of data or information from additional types of submissions.
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 (3)
2022 · fourth_quarter · Health Issues
- HR 1978/S 912, "Protecting Seniors Through Immunization Act", regarding all provisions - HR 6007, "To amend title XVIII of the Social Security Act to provide for the expansion of coverage of vaccines under part B of the Medicare program, and for other purposes", regarding all provisions - H.Res. 446, Expressing support for the goals and ideals of National Stroke Awareness Month, regarding all provisions - S 610/HR 1667, "The Dr. Lorna Breen Health Care Provider Protection Act", regarding all provisions - HR 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - S 1784/HR 3353, Contact Lens Prescription Verification Modernization Act, regarding all provisions - HR 5030/S 2706, "The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, regarding all provisions - S 3394, "Emergency Use Transparency Act", regarding all provisions - HR 3990/S 2047, "No PFAS in Cosmetics Act", regarding all provisions - HR 8299/S 4386, "To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.", regarding all provisions - HR 7667/S 4348, "Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act", regarding provisions on accelerated approval and diversity in clinical studies - HR 5801, "HELP Copays Act", regarding all provisions - HR 3173/S 3018 - "Improving Seniors Timely Access to Care Act of 2021", regarding all provisions - S 3799 - "PREVENT Pandemics Act", regarding all provisions - HR 3932/S 2076 - "PASTEUR Act of 2021", regarding all provisions - HR 5376 - "Inflation Reduction Act", regarding provisions on drug pricing and provisions related to revenue - HR 7559 - Prescription Information Modernization Act of 2022, regarding all provisions - HR 2617 - "Consolidated Appropriations Act, 2023", regarding provisions related to pharmaceuticals, medical devices, mental health, and tax - Issues related to Dengue - Issues related to prescription drug pricing - Issues related to health care pricing transparency - Issues related to maternal health - Issues related to frontline health workers - Issues related to over the counter products - Issues related to the regulation of cosmetic products - Issues related to the regulation of dietary supplements - Issues related to stroke care - Issues related to counterfeit health care goods - Issues related to 340B drug pricing program - Issues related to antimicrobial resistance - Issues related to the COVID-19 vaccine development, including diversity in clinical trials - Issues related to Medicare Part D's 6 protected classes - Issues related to global public health and ending tuberculosis - Issues pertaining to health equity and social determinants of health - Issues related to FDA medical device shortage reporting requirements, including implementation of CARES Act requirements - Issues related to lung cancer screening - Issues related to clinical research diversity - Issues related to international harmonization of medical device regulation
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
Client expense: $2,270,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
- HR 1978/S 912, "Protecting Seniors Through Immunization Act", regarding all provisions - HR 6007, "To amend title XVIII of the Social Security Act to provide for the expansion of coverage of vaccines under part B of the Medicare program, and for other purposes", regarding all provisions - H.Res. 446, Expressing support for the goals and ideals of National Stroke Awareness Month, regarding all provisions - S 610/HR 1667, "The Dr. Lorna Breen Health Care Provider Protection Act", regarding all provisions - HR 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - S 1784/HR 3353, Contact Lens Prescription Verification Modernization Act, regarding all provisions - HR 5030/S 2706, "The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, regarding all provisions - S 3394, "Emergency Use Transparency Act", regarding all provisions - HR 5376, "Build Back Better Act", regarding provisions on drug pricing and provisions related to revenue - HR 3990/S 2047, "No PFAS in Cosmetics Act", regarding all provisions - HR 8299/S 4386, FDA review of certain changes to software in medical devices or predetermined change control plans - HR 7667/S 4348, "Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act", regarding provisions on accelerated approval and diversity in clinical studies - HR 5801, "HELP Copays Act", regarding all provisions - HR 3173/S 3018 - "Improving Seniors Timely Access to Care Act of 2021" - S 3799 - "PREVENT Pandemics Preparedness Act" - HR 3932/S 2079 - "PASTEUR Act of 2021" - HR 5376 - "Inflation Reduction Act", regarding provisions on prescription drugs - Issues related to Dengue - Issues related to prescription drug pricing - Issues related to health care pricing transparency - Issues related to maternal health - Issues related to frontline health workers - Issues related to over the counter products - Issues related to the regulation of cosmetic products - Issues related to the regulation of dietary supplements - Issues related to stroke care - Issues related to counterfeit health care goods - Issues related to 340B drug pricing program - Issues related to antimicrobial resistance - Issues related to the COVID-19 vaccine development, including diversity in clinical trials - Issues related to Medicare Part D's 6 protected classes - Issues related to global public health and ending tuberculosis - Issues pertaining to health equity and social determinants of health - Issues related to FDA medical device shortage reporting requirements, including implementation of CARES Act requirements - Issues related to lung cancer screening - Issues related to clinical research diversity - Issues related to international harmonization of medical device regulation
Client expense: $2,170,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
- HR 1978/S 912, "Protecting Seniors Through Immunization Act", regarding all provisions - HR 6007, "To amend title XVIII of the Social Security Act to provide for the expansion of coverage of vaccines under part B of the Medicare program, and for other purposes", regarding all provisions - H.Res. 446, Expressing support for the goals and ideals of National Stroke Awareness Month, regarding all provisions - S 610/HR 1667, "The Dr. Lorna Breen Health Care Provider Protection Act", regarding all provisions - HR 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - S 1784/HR 3353, Contact Lens Prescription Verification Modernization Act, regarding all provisions - HR 5030/S 2706, "The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, regarding all provisions - S 3394, "Emergency Use Transparency Act", regarding all provisions - HR 5376, "Build Back Better Act", regarding provisions on drug pricing and provisions related to revenue - HR 3990/S 2047, "No PFAS in Cosmetics Act", regarding all provisions - HR 8299/S 4386, FDA review of certain changes to software in medical devices or predetermined change control plans - HR 7667/S 4348, "Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act", regarding provisions on accelerated approval and diversity in clinical studies - HR 5801, "HELP Copays Act", regarding all provisions - Issues related to prescription drug pricing - Issues related to health care pricing transparency - Issues related to maternal health - Issues related to frontline health workers - Issues related to over the counter products - Issues related to the regulation of cosmetic products - Issues related to the regulation of dietary supplements - Issues related to stroke care - Issues related to counterfeit health care goods - Issues related to 340B drug pricing program - Issues related to antimicrobial resistance - Issues related to the COVID-19 vaccine development, including diversity in clinical trials - Issues related to Medicare Part D's 6 protected classes - Issues related to global public health and ending tuberculosis - Issues pertaining to health equity and social determinants of health - Issues related to FDA medical device shortage reporting requirements, including implementation of CARES Act requirements - Issues related to lung cancer screening - Issues related to clinical research diversity - Issues related to international harmonization of medical device regulation
Client expense: $1,050,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Health Issues
- HR 1978/S 912, "Protecting Seniors Through Immunization Act", regarding all provisions - HR 6007, legislation to expand access to adult vaccines under Medicare Part B, regarding all provisions - H.Res. 446, Expressing support for the goals and ideals of National Stroke Awareness Month - S 610/HR 1667, "The Dr. Lorna Breen Health Care Provider Protection Act" - HR 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - S 1784/HR 3353, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - HR 5030/S 2706, "The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, regarding all provisions - S 3394, "The Emergency Use Transparency Act", regarding all provisions - HR 5376, "Build Back Better Act", regarding provisions on drug pricing and provisions related to revenue - HR 3990/S 2047, No PFAS in Cosmetics Act - HR 2467, PFAS Action Act of 2021 - Issues related to prescription drug pricing - Issues related to health care pricing transparency - Issues related to maternal health - Issues related to frontline health workers - Issues related to over the counter products - Issues related to the regulation of cosmetic products - Issues related to the regulation of dietary supplements - Issues related to stroke care - Issues related to counterfeit health care goods - Issues related to 340B drug pricing program - Issues related to antimicrobial resistance - Issues related to the COVID-19 vaccine development, including diversity in clinical trials - Issues related to Medicare Part D's 6 protected classes - Issues related to global public health and ending tuberculosis - Issues pertaining to health equity and social determinants of health - Issues related to FDA medical device shortage reporting requirements, including implementation of CARES Act requirements - Issues related to lung cancer screening - Issues related to clinical research diversity - Issues related to international harmonization of medical device regulation - Issues related to FDA review of certain changes to software in medical devices or predetermined change control plans - Issues related to HR ___, "Medical Device User Fee Amendments of 2022"
Client expense: $2,320,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Health Issues
H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 4100/S. 1712: DISARM Act of 2019 Provisions related to antimicrobial drug development H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 5801 HELP Copays Act, provisions related to patient assistance H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 Provisions related to H.R. 7614: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021 H.R. 7616: Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and HR 19/S 2164, Lower Costs, More Cures Act, provisions related to drug pricing HR 1978/S 912 - Protecting Seniors Through Immunization Act HSA/FSA for Dietary Supplements H.R. 6000: Cures 2.0 Act - Provisions related to health research S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3394: Emergency Use Transparency Act - Provisions related to FDA emergency use authorizations 340B Drug Pricing Program Build Back Better reconciliation package DSHEA 2.0 S. 1619/H.R. 2862: VACCINES Act S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 2304: Strategies To Address Antibiotic Resistance Act Provisions related to antimicrobial resistance (AMR) and other issues S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020 S. 4760/H.R. 8920: PASTEUR Act (AMR) Veterans' Affairs issues related to product sampling 21st Century Cures 2.0 American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Biosimilar approval and reimbursement policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Comprehensive Plan for Addressing High Drug Prices; A Report in Response to the Executive Order on Competition in the American Economy (September 9, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020)
Client expense: $1,000,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2021 · fourth_quarter · Health Issues
H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 4100/S. 1712: DISARM Act of 2019 Provisions related to antimicrobial drug development H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 5801 HELP Copays Act, provisions related to patient assistance H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 Provisions related to H.R. 7614: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021 H.R. 7616: Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and HR 19/S 2164, Lower Costs, More Cures Act, provisions related to drug pricing HR 1978/S 912 - Protecting Seniors Through Immunization Act HSA/FSA for Dietary Supplements H.R. 6000: Cures 2.0 Act - Provisions related to health research S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3394: Emergency Use Transparency Act - Provisions related to FDA emergency use authorizations 340B Drug Pricing Program Build Back Better reconciliation package DSHEA 2.0 S. 1619/H.R. 2862: VACCINES Act S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 2304: Strategies To Address Antibiotic Resistance Act Provisions related to antimicrobial resistance (AMR) and other issues S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020 S. 4760/H.R. 8920: PASTEUR Act (AMR) Veterans' Affairs issues related to product sampling 21st Century Cures 2.0 American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Biosimilar approval and reimbursement policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Comprehensive Plan for Addressing High Drug Prices; A Report in Response to the Executive Order on Competition in the American Economy (September 9, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020)
2021 · fourth_quarter · Health Issues
H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 6000: Cures 2.0 Act - Provisions related to health research S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3394: Emergency Use Transparency Act - Provisions related to FDA emergency use authorizations 21st Century Cures 2.0 American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Biosimilar approval and reimbursement policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Comprehensive Plan for Addressing High Drug Prices; A Report in Response to the Executive Order on Competition in the American Economy (September 9, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020)
2021 · fourth_quarter · Health Issues
- HR 1978/S 912, "Protecting Seniors Through Immunization Act", regarding all provisions - Issues related to prescription drug pricing - Issues pertaining to Medicare coverage of vaccines - Issues related to health care pricing transparency - Issues related to maternal health - Issues related to frontline health workers - Issues related to over the counter products - Issues related to the regulation of cosmetic products - Issues related to the regulation of dietary supplements - HR 446, Expressing support for the goals and ideals of National Stroke Awareness Month - Issues related to stroke care - Issues related to counterfeit health care goods - Issues related to 340B drug pricing program - Issues related to antimicrobial resistance - Issues related to the COVID-19 vaccine development, including diversity in clinical trials - Issues related to Medicare Part D's 6 protected classes - Issues related to global public health and ending tuberculosis - S 610/HR 1667, "The Dr. Lorna Breen Health Care Provider Protection Act" - Issues pertaining to health equity and social determinants of health - Issues related to FDA medical device shortage reporting requirements, including implementation of CARES Act requirements - Issues related to lung cancer screening - HR 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - S 1784/HR 3353, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - HR 5030/S 2706, "The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, regarding all provisions - Issues related to clinical research diversity - S 3394, "The Emergency Use Transparency Act", regarding all provisions - HR 5376, "Build Back Better Act", regarding all provisions
Client expense: $880,000 · Firm income: Not reported
Client expense: $1,000,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $7,160,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE