ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES
What was lobbied
5 issue areas, each in the filer's own words, with who lobbied on it and where.
Pharmacy PHA
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
| Lobbyist | Covered position, as disclosed |
|---|---|
| CRAIG BURTON | — |
| DAVID R. GAUGH | — |
| KARIN HESSLER | — |
| JONATHAN KIMBALL | — |
| ERIK C KOMENDANT | — |
| DANIEL LEONARD | — |
| KATHERINE RAAB | — |
| JOSEPH RUSSO | — |
| STEVEN SELDE | — |
| POLLY WEBSTER | — |
Medicare/Medicaid MMM
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Rebates and Pharmacy Benefit Managers (PBMs). H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Price Negotiation. H.R.5260: Reduced Costs and Continued Cures Act. Medicare Shared Savings Program. H.R.2869/S.1427: Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815: BIOSIM Act. Implementation of the Inflation Reduction Act. H.R.6485/S.3495: Inflation Prevention Act.
| Lobbyist | Covered position, as disclosed |
|---|---|
| CRAIG BURTON | — |
| KARIN HESSLER | — |
| ERIK C KOMENDANT | — |
| KATHERINE RAAB | — |
| JOSEPH RUSSO | — |
| STEVEN SELDE | — |
| POLLY WEBSTER | — |
Copyright/Patent/Trademark CPT
Patent Settlements. Patent Abuse. Skinny Labeling. Inter Partes Review. Impact of IPR decisions on 30-month stay. IPR Amendments. Enhancing Quality of Patents through the PTAB. S.2891: Restoring the America Invents Act. S.4417: Patent Trial and Appeal Board Reform Act of 2022. S.4430: Interagency Patent Coordination and Improvement Act of 2022. S.4704: Patent Examination and Quality Improvement Act of 2022. H.R.6381/S.3521: CREATE Act of 2022.
| Lobbyist | Covered position, as disclosed |
|---|---|
| KARIN HESSLER | — |
| ERIK C KOMENDANT | — |
| KATHERINE RAAB | — |
| JOSEPH RUSSO | — |
| POLLY WEBSTER | — |
Budget/Appropriations BUD
FDA Funding. E-Labeling Prohibition in FY22 Ag-FDA Appropriations.
| Lobbyist | Covered position, as disclosed |
|---|---|
| KARIN HESSLER | — |
| DANIEL LEONARD | — |
| KATHERINE RAAB | — |
Trade (domestic/foreign) TRD
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain Challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. S.3799: PREVENT Pandemics Act.
| Lobbyist | Covered position, as disclosed |
|---|---|
| KARIN HESSLER | — |
| JONATHAN KIMBALL | — |
| KATHERINE RAAB | — |
| JOSEPH RUSSO | — |
Shown as published by the Senate Office of Public Records and the House Clerk under the Lobbying Disclosure Act. The official filing is the record; open it for the full form.