ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

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. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: 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. 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. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. 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]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. 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.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.

Contacted: Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Patent & Trademark Office (PTO); SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 5566 (117th), H.R. 6431 (117th), H.R. 2565 (117th), S. 3576 (117th), H.R. 2883 (117th), H.R. 6996 (117th), H.R. 6000 (117th), S. 3509 (117th), H.R. 6963 (117th), H.R. 6973 (117th), H.R. 5376 (117th), H.R. 7032 (117th), H.R. 2868 (117th), H.R. 5237 (117th), H.R. 7008 (117th), H.R. 6988 (117th), H.R. 5585 (117th), H.R. 4472 (117th), H.R. 6972 (117th), H.R. 3085 (117th), H.R. 6888 (117th), H.R. 7047 (117th), H.R. 7006 (117th), S. 1463 (117th), H.R. 6519 (117th), H.R. 6483 (117th), H.R. 4369 (117th), H.R. 1730 (117th), H.R. 2910 (117th), S. 1462 (117th), H.R. 5030 (117th), H.R. 2831 (117th), S. 2952 (117th), S. 3799 (117th), S. 2910 (117th), H.R. 6584 (117th), H.R. 2870 (117th), S. 1425 (117th), H.R. 2853 (117th), H.R. 7035 (117th), H.R. 4511 (117th)

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.

Contacted: HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); SENATE; Health & Human Services, Dept of (HHS)

Bills named: H.R. 2815 (117th), H.R. 2868 (117th), S. 1427 (117th), H.R. 2846 (117th), H.R. 5260 (117th), H.R. 2869 (117th)

Copyright/Patent/Trademark CPT

Patent Settlements. H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act. H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021. Patent Abuse. H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. Skinny Labeling. REMEDY Act. BPCIA Patent Dance. Patent Listings in Orange Book. Inter Partes Review. Impact of IPR decisions on 30-month stay. Section 101 of the Patent Act. Product Hopping. H.R.2873/S.1435: Affordable Prescriptions for Patients Act of 2021. TAB Appointments Clause (Arthrex Case). Enhancing Quality of Patents through the PTAB. H.R._/S.2891: Restoring the America Invents Act.

Contacted: SENATE; Patent & Trademark Office (PTO); Government Accountability Office (GAO); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA)

Bills named: H.R. 2884 (117th), H.R. 153 (117th), S. 1428 (117th), H.R. 2891 (117th), S. 1435 (117th), H.R. 2873 (117th), S. 2891 (117th)

Budget/Appropriations BUD

FDA Funding. E-Labeling Prohibition in FY22 Ag-FDA Appropriations.

Contacted: Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; SENATE

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. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Shipping Delays. US-India Trade Discussions. China Patent Listing. 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: MADE in America Act.

Contacted: HOUSE OF REPRESENTATIVES; White House Office; U.S. Trade Representative (USTR); Commerce, Dept of (DOC); Health & Human Services, Dept of (HHS); SENATE; Federal Emergency Management Agency (FEMA)

Bills named: S. 3799 (117th), H.R. 3927 (117th), H.R. 2870 (117th), H.R. 4711 (117th), S. 1260 (117th), H.R. 4521 (117th)