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FDA Proposes Accelerated Approval Reform — 180-Day Confirmatory Study Mandate

FDA proposed rule requiring confirmatory study initiation within 180 days of accelerated approval and 3-year enrollment completion. Failure triggers expedited withdrawal proceedings.

CMS Expands Medicare Drug Price Negotiation List — 30 Additional Drugs

CMS published the final list of 30 additional drugs for Medicare price negotiation under the IRA. 11 National Biopharma Alliance members have products on the expanded list with combined revenue exposure of $8.2B annually.

Senate Finance Committee Advances ESOP Expansion Bill — 19-7 Vote

Retirement Security Enhancement Act with 25% ESOP tax credit and $50M formation fund advanced with strong bipartisan support. Significant for health sector talent retention.

House Oversight Committee Launches AI Procurement Investigation

Formal investigation into AI use in federal procurement. Document preservation notices to 15 agencies, subpoenas expected within 72 hours. Focus on algorithmic bias and transparency.

PhRMA Files Constitutional Challenge to IRA Negotiation Framework

PhRMA v. Becerra filed in Delaware federal court challenging the IRA's negotiation framework as unconstitutional taking and compelled speech. Court declined preliminary injunction but case proceeds.