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Califf Clears First Senate Hurdle, But FDA Abortion Pill Decision May Complicate Final Confirmation

 
• By Sarah Karlin-Smith

Republican opposition to Califf over the agency’s recent move to relax its Mifeprex restrictions is ominous since in order be confirmed as FDA commissioner he’ll need enough GOP votes to make up for Democratic opposition over his opioid track record and connections to the drug industry.

Robert Califf testisified 14 Dec 2022 at the Senate HELP committee
Robert Califf testified on 14 December at the Senate HELP Committee • Source: Alamy

The Senate Health Committee voted 13-8 on 13 January to advance Robert Califf’s nomination to lead the US Food and Drug Administration. The positive but close vote sharply contrasted with his unanimous committee vote when he was confirmed to lead FDA under President Barack Obama and is indicative of a much tougher fight Califf is likely to face on the Senate floor this go round.

A key stumbling block appears to be FDA’s recent action to make it easier for people to access the abortion...

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More from US FDA

BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 
• By Sarah Karlin-Smith and Mandy Jackson

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.

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

 
• By Sue Sutter

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

 
• By Derrick Gingery

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

 
• By Sarah Karlin-Smith and Derrick Gingery

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.

More from Agency Leadership

US FDA May Consolidate Support Services After Extensive Cuts

 
• By Derrick Gingery and Sue Sutter

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.

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

 
• By Sue Sutter

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

 
• By Jessica Merrill and Bridget Silverman

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.