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Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
74pct
47d open
vs 9,698 other HR bills in the 117th — cohort avg 63d
The Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2021 or the PASTEUR Act of 2021 This bill authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs, provides $11 billion in appropriations for activities under the bill, and contains other related provisions. A manufacturer of a Food and Drug Administration-approved antimicrobial drug may apply to HHS to have the drug designated as a critical-need antimicrobial, and HHS may enter into a subscription contract for such a critical-need antimicrobial. The bill imposes certain requirements related to such contracts, including a mechanism to lower payments under the contract in certain instances to limit the manufacturer's revenue from the drug. Furthermore, HHS and the Centers for Disease Control and Prevention (CDC) shall award grants to support efforts to encourage the appropriate use of antimicrobial drugs and efforts to combat antimicrobial resistance. The CDC shall also track and assess data relating to antibacterial resistance and human antibiotic use and make such data publicly available. HHS shall also establish a Committee on Critical Need Antimicrobials. The committee shall develop a list of prioritized infections for which new antimicrobial drug development is needed, among other duties. Within six years of the bill's enactment, the Government Accountability Office shall report to Congress a study on the bill's effectiveness in developing priority antimicrobial drugs.
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Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Oversight, Management, and Accountability.
Referred to the Subcommittee on Health.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Veterans' Affairs, Armed Services, the Judiciary, and Homeland Security, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2023 · fourth_quarter · Medical/Disease Research/Clinical Labs
COVID Supplemental Appropriation S.2076/H.R.3932 - PASTEUR Act of 2021 S.3799 - PREVENT Pandemics Act Issues related to the development of an antibody therapy for COVID-19 Issues related to antimicrobial resistance (AMR) and drug development Issues related to supply chain and biopharmaceutical manufacturing FY2024 Defense Appropriations Issues related to the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) National Biodefense Strategy and Implementation Plan H.R.3746 Fiscal Responsibility Act of 2023 H.R.4421 Preparing for All Hazards and Pathogens Reauthorization Act
Client expense: $240,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2023 · third_quarter · Medical/Disease Research/Clinical Labs
COVID Supplemental Appropriation S.2076/H.R.3932 - PASTEUR Act of 2021 S.3799 - PREVENT Pandemics Act Issues related to the development of an antibody therapy for COVID-19 Issues related to antimicrobial resistance (AMR) and drug development Issues related to supply chain and biopharmaceutical manufacturing FY2024 Defense Appropriations Issues related to the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) National Biodefense Strategy and Implementation Plan H.R.3746 Fiscal Responsibility Act of 2023 H.R.4421 Preparing for All Hazards and Pathogens Reauthorization Act
Client expense: $230,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2023 · second_quarter · Health Issues
Issues related to antimicrobial resistance. H.R. 3932/S. 2076 - The PASTEUR Act of 2021. Consolidated Appropriations Act, 2023 (PL 117-328).
Client expense: Not reported · Firm income: $50,000
Government targets: SENATE
2023 · second_quarter · Medical/Disease Research/Clinical Labs
COVID Supplemental Appropriation S.2076/H.R.3932 - PASTEUR Act of 2021 S.3799 - PREVENT Pandemics Act Issues related to the development of an antibody therapy for COVID-19 Issues related to antimicrobial resistance (AMR) and drug development Issues related to supply chain and biopharmaceutical manufacturing FY2024 Defense Appropriations Issues related to the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) National Biodefense Strategy and Implementation Plan H.R.3746 Fiscal Responsibility Act of 2023 H.R.4421 Preparing for All Hazards and Pathogens Reauthorization Act
Client expense: $230,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2023 · first_quarter · Medical/Disease Research/Clinical Labs
COVID Supplemental Appropriation FY2023 Defense Appropriations S.2076/H.R.3932 - PASTEUR Act of 2021 S.3799 - PREVENT Pandemics Act Issues related to the development of an antibody therapy for COVID-19 Issues related to antimicrobial resistance (AMR) and drug development Issues related to supply chain and biopharmaceutical manufacturing H.R.8236 - Department of Defense Appropriations Act, 2023 H.R.6833 - Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 H.R.2617 - Consolidated Appropriations Act, 2023 FY2024 Defense Appropriations Issues related to the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) National Biodefense Strategy and Implementation Plan
Client expense: $230,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
| Referred to |
| June 16, 2021 |
| Judiciary Committee | House | Referred to | June 16, 2021 |
| Armed Services Committee | House | Referred to | June 16, 2021 |
| Democratic |
| MN |
| Ann M. Kuster | Democratic | NH |
| Antonio Delgado | Democratic | NY |
| Austin Scott | Republican | GA |
| Bill Johnson | Republican | OH |
| Billy Long | Republican | MO |
| Bobby L. Rush | Democratic | IL |
| Brad R. Wenstrup | Republican | OH |
| Brian K. Fitzpatrick | Republican | PA |
| Carolyn Bourdeaux | Democratic | GA |
| Charles J. "Chuck" Fleischmann | Republican | TN |
| Chris Stewart | Republican | UT |
| Daniel Meuser | Republican | PA |
| David G. Valadao | Republican | CA |
| David Schweikert | Republican | AZ |
| Deborah K. Ross | Democratic | NC |
| Derek Kilmer | Democratic | WA |
| Diana DeGette | Democratic | CO |
| Don Bacon | Republican | NE |
| Doris O. Matsui | Democratic | CA |
| Earl L. "Buddy" Carter | Republican | GA |
| Eleanor Holmes Norton | Democratic | DC |
| Frank J. Mrvan | Democratic | IN |
| Fred Upton | Republican | MI |
| G. K. Butterfield | Democratic | NC |
| Gregory F. Murphy | Republican | NC |
| J. French Hill | Republican | AR |
| Jake Auchincloss | Democratic | MA |
| Jake LaTurner | Republican | KS |
| James R. Langevin | Democratic | RI |
| Jeff Duncan | Republican | SC |
| Jefferson Van Drew | Republican | NJ |
| Jenniffer González-Colón | Republican | PR |
| Jimmy Panetta | Democratic | CA |
| John Garamendi | Democratic | CA |
| John Katko | Republican | NY |
| Josh Gottheimer | Democratic | NJ |
| Kim Schrier | Democratic | WA |
| Larry Bucshon | Republican | IN |
| Lucy McBath | Democratic | GA |
| Madeleine Dean | Democratic | PA |
| Maria Elvira Salazar | Republican | FL |
| Mariannette Miller-Meeks | Republican | IA |
| Marie Newman | Democratic | IL |
| Mark DeSaulnier | Democratic | CA |
| Mark E. Amodei | Republican | NV |
| Markwayne Mullin | Republican | OK |
| Michael C. Burgess | Republican | TX |
| Mike Carey | Republican | OH |
| Mike Kelly | Republican | PA |
| Mike Levin | Democratic | CA |
| Mike Quigley | Democratic | IL |
| Nydia M. Velázquez | Democratic | NY |
| Paul Tonko | Democratic | NY |
| Scott H. Peters | Democratic | CA |
| Sean Casten | Democratic | IL |
| Susan Wild | Democratic | PA |
| Ted Lieu | Democratic | CA |
| Tom Emmer | Republican | MN |
| Tom O’Halleran | Democratic | AZ |
| Tony Cárdenas | Democratic | CA |
| Tracey Mann | Republican | KS |
2022 · third_quarter · Medicare/Medicaid
H.R. 1384, the Mainstreaming Addiction Treatment Act S.445, the Mainstreaming Addiction Treatment Act H.R. 2503, the Social Determinants Accelerator Act S. 3039, the Social Determinants Accelerator Act H.R. 3517, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act H.R. 3932, the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act S. 2076, the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act HR 4040, Advancing Telehealth Beyond COVID-19 Act H.R. 4521, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act H.R. 6000, Cures 2.0 Act H.R. 6072, the Leveraging Integrated Networks in Communities (LINC) to Address Social Needs Act S. 509, the Leveraging Integrated Networks in Communities (LINC) to Address Social Needs Act H.R. 6087, the Improving Access to Workers Compensation for Injured Federal Workers Act H.R. 6883, Continuing Appropriations and Ukraine Supplemental Appropriations Act H.R.7008, Pre-approval Information Exchange Act H.R. 7353, the Telehealth Benefit Expansion for Workers Act H.R. 7503, Hospital Inpatient Services Modernization Act S. 3792, Hospital Inpatient Services Modernization Act H.R. 7666, the Restoring Hope for Mental Health and Well-Being Act H.R. 7667, Food and Drug Amendments of 2022 H.R. 8152, American Data Privacy and Protection Act H.R. 8188, the Saving Access to Laboratory Services Act S. 4449, the Saving Access to Laboratory Services Act S. 3799, PREVENT Pandemics Act S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022
Client expense: $160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
H.R. 1384, the Mainstreaming Addiction Treatment Act S.445, the Mainstreaming Addiction Treatment Act H.R. 2503, the Social Determinants Accelerator Act S. 3039, the Social Determinants Accelerator Act H.R. 3517, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act H.R. 3932, the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act S. 2076, the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act HR 4040, Advancing Telehealth Beyond COVID-19 Act H.R. 4521, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act H.R. 6000, Cures 2.0 Act H.R. 6072, the Leveraging Integrated Networks in Communities (LINC) to Address Social Needs Act S. 509, the Leveraging Integrated Networks in Communities (LINC) to Address Social Needs Act H.R. 6087, the Improving Access to Workers Compensation for Injured Federal Workers Act H.R. 6883, Continuing Appropriations and Ukraine Supplemental Appropriations Act H.R.7008, Pre-approval Information Exchange Act H.R. 7353, the Telehealth Benefit Expansion for Workers Act H.R. 7503, Hospital Inpatient Services Modernization Act S. 3792, Hospital Inpatient Services Modernization Act H.R. 7666, the Restoring Hope for Mental Health and Well-Being Act H.R. 7667, Food and Drug Amendments of 2022 H.R. 8152, American Data Privacy and Protection Act H.R. 8188, the Saving Access to Laboratory Services Act S. 4449, the Saving Access to Laboratory Services Act S. 3799, PREVENT Pandemics Act S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022
Client expense: $160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Health Issues
Drug Pricing Support of Biosimilars Out-of-Pocket Costs Rebate Reform Vaccine Infrastructure/HR 3656 Excise Tax- S.3087 Antimicrobial Resistance/HR 3932/PASTEUR Act COVID Relief Package/Appropriations PDUFA
Client expense: $2,390,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2022 · first_quarter · Health Issues
Drug Pricing Biosimilars Out-of-Pocket Costs Rebate Reform Vaccine Infrastructure/HR 3656 Excise Tax Antimicrobial Resistance/HR 3932 COVID Relief Package/Appropriations PDUFA
Client expense: $2,730,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2022 · fourth_quarter · Health Issues
Reproductive health, physician-patient relationship, and EMTALA issues H.R.1193-Cardiovascular Advances in Research and Opportunities Legacy Act H.R.1195-Workplace Violence Prevention for Health Care and Social Service Workers Act H.R.1205-Improving Mental Health Access from the Emergency Department Act of 2021 H.R.1260-Bipartisan Solution to Cyclical Violence Act of 2021 H.R.1324-Effective Suicide Screening and Assessment in the Emergency Department Act of 2021 H.R.1364-Parity Enforcement Act of 2021 H.R.1384-Mainstreaming Addiction Treatment Act of 2021 H.R.1620-Violence Against Women Act Reauthorization Act of 2021 H.R.3650-Improving Access to Medicare Coverage Act of 2021 H.R.3932-Pioneering Antimicrobial Subscriptions to End Up Surging Resistance Act of 2021 H.R.4555-Oral Health Literacy and Awareness Act of 2021 H.R.5294-Meaningful Access to Federal Health Plan Claims Data Act of 2021 H.R.7666-Restoring Hope for Mental Health H.R.7850-Prevent BLEEDing Act of 2022 H.R.8163-Improving Trauma Systems and Emergency Care Act H.R.8597-Emergency Care Improvement Act H.Res.656-Supporting the designation of September 17, 2021, as National Physician Suicide Awareness Day to raise awareness of, and promote a national discussion about, physician suicide and to reduce the stigma of mental health issues S.445-Mainstreaming Addiction Treatment Act of 2021 S.467-Effective Suicide Screening and Assessment in the Emergency Department Act of 2021 S.1133-Cardiovascular Advances in Research and Opportunities Legacy Act S.2048-Improving Access to Medicare Coverage Act of 2021 S.2076-Pioneering Antimicrobial Subscriptions to End Up Surging Resistance Act of 2021 S.2157-Improving Mental Health Access from the Emergency Department Act of 2021 S.2422-Bipartisan Solution to Cyclical Violence Act S.3566-Improving Trauma Systems and Emergency Care Act S. 4269-Prevent BLEEDing Act S.Res.364-Supporting the designation of September 17, 2021, as National Physician Suicide Awareness Day to raise awareness of, and promote a national discussion about, physician suicide and to reduce the stigma of mental health issues. S.Res.557-A resolution recognizing the week of March 20 through March 26, 2022, as National Poison Prevention Week and encouraging communities across the United States to raise awareness of the dangers of poisoning and promote poison prevention.
Client expense: $515,937 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Antimicrobial resistance research, infectious disease product R&D regulatory science, unnecessary regulatory burdens placed on medical research; laboratory developed tests; comparative effectiveness research; support for evidence-based decision making; point-of-care diagnostic tests; and organ transplant policies to allow HIV+ to HIV+ organ transplants, Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR Act-S. 2076/H.R. 3932), Verifying Accurate Leading Edge IVCT Development (S. 2209/HR. 4128), PREVENT Pandemics Act
Client expense: $166,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE
2022 · fourth_quarter · Health Issues
Support the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (S. 2076 / H.R. 3932)
Client expense: Not reported · Firm income: $21,600
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
Legislation and policies related to: APRN prescribing authority Development, testing and prescribing of pediatric pharmaceuticals Implementation of the Inflation Reduction Act (P.L. 117-169) provisions related to policies to lower prescription drug prices and improve vaccines for children H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 3932/S. 2076, Pioneering Antimicrobial Subscriptions to End Surging Resistance (PASTEUR) Act
Client expense: Not reported · Firm income: $24,000
Government targets: Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 869: RESEARCH INVESTMENT TO SPARK THE ECONOMY (RISE) ACT OF 2021; ALL PROVISIONS H.R. 3932: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS H.R. 5030: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS H.R. 5566: FINDING ORPHAN-DISEASE REMEDIES WITH ANTIFUNGAL RESEARCH AND DEVELOPMENT (FORWARD) ACT OF 2021; ALL PROVISIONS H.R. 6000: CURES 2.0 ACT; ALL PROVISIONS S. 289: RESEARCH INVESTMENT TO SPARK THE ECONOMY (RISE) ACT OF 2021; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 2076: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS S. 2706: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS S. 3799: PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING THE 2023 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR HHS AND RELATED AGENCIES, FDA AND RELATED AGENCIES, CDC AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 3932: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS H.R. 4040: ADVANCING TELEHEALTH BEYOND COVID-19 ACT OF 2022; ALL PROVISIONS H.R. 5030: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS H.R. 5566: FINDING ORPHAN-DISEASE REMEDIES WITH ANTIFUNGAL RESEARCH AND DEVELOPMENT (FORWARD) ACT OF 2021; ALL PROVISIONS H.R. 5801: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 6000: CURES 2.0 ACT; ALL PROVISIONS H.R. 9303: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2022; ALL PROVISIONS S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 942: NO JUNK PLANS ACT; ALL PROVISIONS S. 2076: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS S. 2706: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS S. 3799: PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING ACE KIDS 2.0; ALL PROVISIONS
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Drug Pricing Support of Biosimilars Out-of-Pocket Costs Rebate Reform Vaccine Infrastructure/HR 3656 Excise Tax- S.3087 Antimicrobial Resistance/HR 3932/PASTEUR Act COVID Relief Package/Appropriations PDUFA
Client expense: $3,050,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2022 · fourth_quarter · Health Issues
-FDA continue focus on COVID-19 prevention and treatment options -Patient access to next generation therapeutics to fight COVID-19 -Planning and content of the National Institute on Aging's Research Summit -Support the PASTUER Act (H.R. 3932)
Client expense: Not reported · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
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
Client expense: $2,270,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 623: Gabriella Miller Kids First Research Act 2.0 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. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products HR 1978 - Protecting Seniors Through Immunization Act 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. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - 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. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing, patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180); PDUFA provisions related to intellectual property H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act 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. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals 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. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health 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 Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Issues related to HFC's Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Veterans' Affairs issues related to product sampling Provisions related to the importation of HFCs, necessary for MDI production. P.L.116-260 - AIM Act - EPA Propellant Allowances for metered dose inhaler manufacturing PDUFA riders legislation (Accelerated Approval, Clinical Trial Diversity, Q1Q2)
Client expense: $860,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Budget/Appropriations
H.R. 2617: Consolidated Appropriations Act, 2023 (PL. 117-328) - various funding levels; FDA provisions H.R. 3932: PASTEUR Act of 2021- To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169), prescription drug provisions H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 H.R. 8256: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2023 H.R. 8295: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 S. 2076: PASTEUR Act of 2021- To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections S. 4543: James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 FY 2023 Presidents Budget Request National Coverage Determination (NCD) for Apretude (cabotegravir long-acting [CAB-LA] for Pre-Exposure Prophylaxis [PrEP]) PAHPA Reauthorization Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates
Client expense: $860,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
General education about policies impacting pharmaceutical development, approval and reimbursement; Drug safety and drug counterfeiting; Medicare Part D; Federal preemption for prescription drugs; drug importation; and drug shortages. Drug pricing proposals including H.R. 3. Medicare rebate reform, the 340B program, and proposals to impose "most favored nation" pricing on Medicare Part B and D. COVID-19 relief proposals. American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). H.R. 3. H.R. 19. HR 3927. S. 2082. Consolidated Appropriations Act, FY 23 (P.L. 117-328). PASTEUR Act H.R. 3932, S. 2076.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 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. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research 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. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias 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. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act 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. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias 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. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health 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 Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Client expense: $6,610,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Budget/Appropriations
H.R. 2617: Consolidated Appropriations Act, 2023 (PL. 117-328) H.R. 3932: PASTEUR Act of 2021 - To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 H.R. 8256: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2023 H.R. 8295: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 S. 2076: PASTEUR Act of 2021 - To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections S. 4543: James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 FY 2023 Presidents Budget Request
Client expense: $6,610,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to third party servicing of medical devices Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of COVID-19 diagnostic tests Issues related to the Valid Act of 2021 - H.R. 4128/S. 2209 Issues related to Health Equity Issues related to the PASTEUR Act of 2021 - S. 2076/HR 3932 Issues related to COVID-19 Clinical Testing & Testing Supplies Issues related to Public Health Emergency Preparedness Issues related to PFAS Chemical regulation, H.R. 2457 PFAS Action Act Issues related to COVID-19 Clinical Testing and Testing Supplies Issues related to consumer and health data privacy Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation, H.R. 2457 PFAS Action Act Issues related to H.R. 7667, Food and Drug Amendments of 2022 Issues related to S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Issues related to S. 4386, A bill 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. Issues related to S. 3799, PREVENT Pandemics Act Issues related to S. 3700 Prevent Pandemics Act Issues related to H.R. 2617 Consolidated Appropriations Act Issues related to H.R. 6833 Continuing Appropriations and Ukraine Supplemental Appropriations Act Issues related to S. 4349 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices. Issues related to H.R. 7676 Emerging Signals Modernization Act of 2022 Issues related to cyber security including H.R. 7084/S. 3983, PATCH Act and S. 4336 Strengthening Cybersecurity for Medical Devices Act
Client expense: $750,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2022 · fourth_quarter · Health Issues
Inflation Reduction Act of 2022 (PL 117-169) implementation - creating Medicare negotiation of drugs, creating a new inflation rebate under Medicare, limiting insulin copays to $35/month, capping Medicare Part D premium growth, expanding premium and co-pay assistance on prescription drugs for low-income individuals, and capping Medicare out of pocket costs at $2,000 per year, and preventing commercial spillover of maximum fair price into markets beyond Medicare; Consolidated Appropriations Act, 2023 (PL 117-328)- allowing new vaccines to be added to the Vaccine Injury Compensation Fund (VICF), preserving coverage and access to Part D products under EUA; Antibiotics/stewardship; Value of prescription drugs; S. 2076/H.R. 3932, PASTEUR Act of 2021; ACIP recommendations related to pneumococcal vaccines; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to reauthorization of FDA user fee bills (H.R.7667, Food and Drug Amendments of 2022; S. 4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)), including accelerated approval and reimportation; Issues related to the Public Health Emergency; Issues related to the White House Cancer Moonshot initiative; S. 2706/H.R. 5030, DIVERSE Trials Act; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Issues relating to the further development of antibiotics and antimicrobials for serious and unmet medical needs; Antibiotics/stewardship; S.2076/H.R.3932, PASTEUR Act of 2021; Value of prescription drugs; Issues related to Medicare Parts B and D; Issues related to Vaccine Injury Compensation Fund (VICF); Issues related to coverage of EUA products in Part D
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
Pandemic preparedness; Antimicrobial resistance; PASTEUR Act (H.R. 3932 and S. 2076)
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
COVID Supplemental Appropriation FY2023 Defense Appropriations S.2076/H.R.3932 - PASTEUR Act of 2021 S.3799 - PREVENT Pandemics Act Issues related to the development of an antibody therapy for COVID-19 Issues related to antimicrobial resistance (AMR) and drug development Issues related to supply chain and biopharmaceutical manufacturing H.R.8236 - Department of Defense Appropriations Act, 2023 H.R.7667 - Food and Drug Amendments of 2022 S.4348 - Food and Drug Administration Safety and Landmark Advancements Act (FDASLA) of 2022 H.R.5585 - Advanced Research Projects Agency - Health (ARPA-H) Act S.3819 - Advanced Research Project Authority for Health (ARPA-H) Act H.R.6833 - Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 H.R.2617 - Consolidated Appropriations Act, 2023
Client expense: $210,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medicare/Medicaid
Medicare Coverage and Reimbursement issues, including issues related to the Medicare Part B and D Coverage; Issues related to drug pricing; H.R. 1319, the American Rescue Plan Act (P.L. 117-2); H.R. 5376, Build Back Better Act (Public Law No: 117-169); H.R. 2617 - Consolidated Appropriations Act, 2023 (P.L. No: 117-328), issues related to Medicare Part D emergency use authorization coverage; H.R. 3932 (PASTEUR Act).
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
Pandemic preparedness; Antimicrobial resistance; PASTEUR Act (H.R. 3932 and S. 2076)
Client expense: Not reported · Firm income: Not reported
2022 · fourth_quarter · Health Issues
FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348); Food and Drug Amendments of 2022 (H.R. 7667); Diverse and Equitable Participation in Clinical Trials Act (H.R. 6584); Advanced Research Project Agency-Health Act (H.R. 5585); America COMPETES Act of 2022 (H.R. 4521); Interagency Patent Coordination and Improvement Act of 2022 (S. 4430); Increasing Prescription Drug Competition Act (S. 4918); Consolidated Appropriations Act, 2023 (H.R. 2617); PASTEUR Act of 2021 (H.R. 3932/S. 2076); Biologics Competition Act of 2022 (H.R. 8877); Give Kids a Chance Act of 2022 (S. 4125/H.R. 6972); Orange Book listing issues; Bayh-Dole Act.
Client expense: Not reported · Firm income: $100,000
2022 · fourth_quarter · Health Issues
Issues related to drug pricing; implementation of H.R.5376, Inflation Reduction Act of 2022 (P.L.117-169). Issues related to COVID-19 response including vaccines and anti-viral therapies; H.R.7007, COVID Supplemental Appropriations Act, 2022. Issues related to the FY2023 Appropriations Process. Issues related to drug supply chain; H.R.3927/S.2082, MADE in America Act. Issues related to PDUFA Reauthorization; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022. 340B drug discount program policy issues. Antimicrobial Resistance; H.R.3932, PASTEUR Act. Discussions regarding health package in Year-End Omnibus; H.R.2617, Consolidated Appropriations Act, 2023.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Supporting Funding for the National Institutes of Health (NIH) research and the Food and Drug Administration that benefits people with cystic fibrosis. Tracking developments related to S.2076/H.R.3932, the PASTEUR Act, and incusion of the bill in the end-of-year omnibus. Highlighting the importance of FDA policies on patients with rare diseases.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
340B Program issues and patient access to pharmaceuticals, including monitor related provisions in Sec. 121, H.R. 2471, Consolidated Appropriations Act, 2022, P.L. 117-103. Coronavirus response efforts, including S. 3799, the PREVENT Pandemics Act, and implementation of related provisions in H.R. 1319, the American Rescue Plan Act (P.L. 117-2). Legislative issues associated with patient access to treatment, including: the CMMI Most Favored Nation and related demonstration initiatives; and step therapy, including related provisions in S. 464/H.R. 2163, the Safe Step Act. Medical Supply Chain, including issues related to a new rating system; targeted action to support the diversification of certain supplies; additional funding to the Strategic National Stockpile (SNS) and more diverse stockpile; increasing flexibility for supply chains. Enhanced FDA reporting and risk mitigation plans for certain medicines, including related provisions in Division F, FDA User Fee Reauthorization Act, of H.R. 6833, providing continuing appropriations for FY 2023. Incentives for antimicrobial and antiviral research and novel product development, including related provisions in H.R. 3932, to establish a program to develop antimicrobial innovations.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Antibiotic research and development; S. 3799, PREVENT Pandemics Act; H.R. 3932/S. 2076, the PASTEUR Act.
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 1976 / S. 4204- "Medicare for All Act" - Single-payer healthcare systems. H.R. 2617 - Consolidated Appropriations Act, 2023 - Provisions related to health care H.R. 1227/ S.386 - "Medicare-X Choice Act of 2021" - Public Option Healthcare systems S. 2428 - False Claims Amendments Act of 2021 - False Claims Act Amendments H.R. 8201 - Promoting Health Care Quality Act of 2022 - Health care quality provisions under the Medicare program. S. 3799 - "PREVENT Pandemics Act" - pandemic preparedness H.R.3932/ S. 2076 - "PASTEUR Act of 2021" - addressing antimicrobial resistance (AMR) Support continued Congressional work on behavioral health
Client expense: $620,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2022 · fourth_quarter · Health Issues
H.R. 3932 / S. 2076, The PASTEUR Act and issues related to sepsis treatment and antibiotic stewardship.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
Issues surrounding antimicrobial preparedness H.R.4127 - DISARM Act of 2021 H.R.3932/S.2076 - PASTEUR Act of 2021
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2022 · fourth_quarter · Health Issues
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---S.4351/H.R. 6973: Enhanced Access to Affordable Medicines Act ---S.4338/H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Rare Pediatric Disease Priority Review ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4509 Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Client expense: $3,740,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2022 · fourth_quarter · Budget/Appropriations
Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for the USDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX
Client expense: $3,740,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2022 · fourth_quarter · Homeland Security
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA
Client expense: $3,740,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
Client expense: $3,740,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office
2022 · fourth_quarter · Health Issues
Bills -H.R. 2163/S. 464 - Safe Step Act -S.1773 - Prescription Drug Pricing Dashboard Act -H.R. 5376 - Build Back Better Act -H.R. 3684- Infrastructure Investment and Jobs Act -H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act -S.2076/H.R. 3932 PASTEUR Act -S. 3799- PREVENT Pandemics Act -H.R.4521 - COMPETES Act of 2022 -S.1260 - United States Innovation and Competition Act of 2021 -H.R.6963 - Accelerated Approval Integrity Act of 2022 -H.R.6996 - Accelerating Access for Patients Act of 2022 -H.R. 2565 / S.2952 the FDA Modernization Act -H.R. 6972 - Give Kids a Chance Act -H.R. 1730 - STAT Act -H.R. 7032 - Increasing Transparency in Generic Drug Applications Act -H.R. 5030/S. 2706 - DIVERSE Trials Act -H.R. 6584 - DEPICT Act -H.R. 9476- Influenza Act of 2022 Issues -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing -Issues related to healthcare legislation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to health equity, diversity, and inclusion in clinical trials -Issues related to advanced development and procurement of medical countermeasures (MCMs) -Issues related to patient assistance and access -Issues relating to privacy and securing the data of and personal information of consumers -Issues relating to medical research data -Issues relating to screening and diagnostics -Issues related to public health preparedness and response -Issues related to awareness about diabetic eye diseases in minority populations
Client expense: $1,630,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 2471 Consolidated Appropriations Act, FY2022 S.2076/H.R. 3932 PASTEUR Act H.R.7667 - Food and Drug Amendments of 2022 S.4348 - FDASLA Act of 2022 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act H.R.3085 - ENACT Act of 2021 -Issues related to public health protection including influenza development and preparedness -Issues related to antimicrobial and antiviral research and product development -Issues related to novel coronavirus and COVID-19 research and product development -Issues related to drug development including PDUFA and Cures 2.0
Client expense: $1,630,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 5602 and S. 3244 (Bolstering Infectious Outbreaks (BIO) Preparedness Workforce Act of 2021), all provisions H.R. 3932 and S. 2076 (PASTEUR Act of 2021), all provisions H.R. 3297 (Public Health Workforce Loan Repayment Act of 2021), all provisions - Reauthorization of the Public Health Workforce Loan Repayment Program S. 3799 (PREVENT Pandemics Act), all provisions H.R. 2617 (Consolidated Appropriations Act, 2023), Division FF, Section 2221, regarding Bio-Preparedness Workforce Pilot Program
Client expense: Not reported · Firm income: $50,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
Allergy policies (S. 701/H.R. 4114); Diagnostic test reimbursement & regulatory policies (S. 2209/H.R. 4128, S. 2076/H.R. 3932, S.4449/H.R.8188, CY23 CLFS); Precision Medicine (H.R. 6000/H.R. 5989); COVID preparedness products and services; Healthcare supply chain (S. 1693/H.R. 3463, P.L. 117-328); Future pandemic preparedness & response (S. 3799, H.R. 7152/S. 3534, H.R. 3635/S. 1974, P.L. 117-328); User Fees Reauthorization (S. 4328/H.R. 7667); ARPA-H (S. 3819/H.R. 5585); Biotechnology and biomanufacturing.
Client expense: $450,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2022 · fourth_quarter · Health Issues
Dietary Supplements and VALID Act- H.R.4128, S.2209 Pasteur Act- H.R.3932, S.2076
Client expense: $180,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Opposing legislation regarding health care costs. Opposing various legislative efforts to relocate supply and logistics chains. Opposing various legislative and executive efforts to impose an international price index. Supporting the DISARM Act (H.R. 4127). Supporting the PASTEUR Act (S. 2076 and H.R. 3932). Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 7559). Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting CMS proposed rule on Medicare Coverage of Innovative Technology (MCIT). Engaging various components of the Build Back Better Act. Opposing CMS reimbursement for combined diagnostics test. Opposing TRIPS waiver. Supporting PDUFA and MDUFA passage. Commenting on risk management to mitigate drug shortages. Supporting the extension of the SBIR program. Supporting H.R. 8188, the Saving Access to Laboratory Services Act (SALSA). Supporting H.R. 4346, the Creating Helpful Incentives to Produce Semiconductors (CHIPS) Act. Opposing the Inflation Reduction Act. Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act
Client expense: $55,145 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Patient protection; Drug supply chain and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; "Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act 2021" (S 2076 & HR.3932); "Inflation Reduction Act" (HR.5376); Affordable Prescriptions for Patients Act of 2021 (S.1435); Prescription Drug User Fee reauthorization; prescription drug approval; Affordable Insulin Now Act (S.3700/HR.6833), The INSULIN Act
Client expense: $2,021,850 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to antimicrobial resistance.; H.R. 3932/S. 2076 - The PASTEUR Act. Consolidated Appropriations Act, 2023 (PL 117-328).
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE