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 of 2022. 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: ADPT 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. Labeling of Generic Drugs and Biosimilars. 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. 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. Inspections Legislative Proposals. Energy and 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: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
| 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 | — |
| CHRISTINE SIMMON | — |
| 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. 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.
| Lobbyist | Covered position, as disclosed |
|---|---|
| CRAIG BURTON | — |
| KARIN HESSLER | — |
| ERIK C KOMENDANT | — |
| DANIEL LEONARD | — |
| KATHERINE RAAB | — |
| JOSEPH RUSSO | — |
| STEVEN SELDE | — |
| CHRISTINE SIMMON | — |
| POLLY WEBSTER | — |
Copyright/Patent/Trademark CPT
Patent Settlements. Patent Abuse. Skinny Labeling. REMEDY Act. Patent Listings in Orange Book. Inter Partes Review. Impact of IPR decisions on 30-month stay. Section 101 of the Patent Act. Product Hopping. TAB Appointments Clause (Arthrex Case). Enhancing Quality of Patents through the PTAB. H.R._/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.
| Lobbyist | Covered position, as disclosed |
|---|---|
| KARIN HESSLER | — |
| ERIK C KOMENDANT | — |
| DANIEL LEONARD | — |
| 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 | — |
| ERIK C KOMENDANT | — |
| KATHERINE RAAB | — |
| JOSEPH RUSSO | — |
| POLLY WEBSTER | — |
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. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Shipping Delays. US-India Trade Discussions. US-UK Intellectual Property Policies. S.3799: PREVENT Pandemics Act. H.R.4521: America COMPETES Act of 2022. S.1260: United States Innovation and Competition Act of 2021. H.R.3927/S.2082: MADE in America Act.
| Lobbyist | Covered position, as disclosed |
|---|---|
| CRAIG BURTON | — |
| KARIN HESSLER | — |
| JONATHAN KIMBALL | — |
| ERIK C KOMENDANT | — |
| KATHERINE RAAB | — |
| JOSEPH RUSSO | — |
| POLLY WEBSTER | — |
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.