NDAA Change Feed
5 changes detected this week
Today, March 12
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.
File coordinated public comments within 60-day window. Deploy dual-pressure narrative in congressional engagement. Commission independent economic analysis of compounding impact.
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.
Convene emergency health practice meeting. Activate Cassidy-Menendez small biotech amendment advocacy. Brief all affected clients within 48 hours.
Yesterday, March 11
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.
Connect interested clients with Noelle Montaño's tax practice for ESOP structuring. Monitor floor vote timeline.
Tuesday, March 10
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.
Brief MedTech Coalition members with federal AI deployments. Prepare voluntary cooperation framework for at-risk clients.
Sunday, March 8
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.
Monitor case proceedings. Prepare NBA members for both outcomes — legal victory would not come before 2028 at earliest.