Shutdown Deal Avoids Further US FDA Service Cuts, But Damage May Linger

Employees are no doubt are excited to resume work and may have a dozen or more major NDAs pending, but agency morale may not recover quickly.

Early morning sky background, sunlight through white clouds and free birds flying away
President Trump has reached a deal with Democrats to temporarily reopen shuttered federal agencies until Feb. 15, so it should be blue skies ahead for FDA.

US FDA Commissioner Scott Gottlieb did not wait for President Trump to finish his speech announcing the deal to end the government shutdown to voice his excitement.

"I'm delighted by the announcement by [President Trump] of a deal to re-open the federal government," Gottlieb tweeted. "I'm inspired...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By 

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

US FDA May Consolidate Support Services After Extensive Cuts

 

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

More from Agency Leadership

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By 

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

ACIP Upheaval Leaves Merck & Co. In A Lurch

 

Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.

US FDA Chief Counsel Position Awaits HHS General Counsel Confirmation

 
• By 

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.