FDA Policy/General

New Congress’ Impact on FDA Leadership, User Fee Reauthorization: Analyst

Democratic control of Congress following the 11/3 midterm elections could bring increased oversight of FDA and HHS, complicate the nomination of a permanent FDA commissioner and turn the 2027 user fee reauthorization into a vehicle for broader health policy legislation, according to FDA policy analyst and former HHS official Steven Grossman.

In an 11/6 MedPage Today commentary, Grossman predicted that Democrats would use their new congressional majorities to investigate the Trump administration's health policies, particularly its approach to vaccines.

Grossman predicted that FDA commissioner-nominee Heidi Overton would be unlikely to win confirmation during the lame-duck session and would face higher hurdles in a Democratic-controlled Senate next year. He raised the possibility that Overton could be renominated to facilitate Kyle Diamantas' continued service as acting commissioner, although he considered the emergence of another nominee more likely.

He also questioned whether HHS secretary Robert F. Kennedy Jr. would stay on for the administration’s second half amid potentially contentious congressional hearings, suggesting Kennedy might resign rather than face sustained oversight.

Additionally, the analyst identified FDA user fees reauthorization as a potential legislative battleground. The agreements must be renewed before 9/30/2027, and Grossman said Democrats could seek to attach broader regulatory measures, including the Clinical Trial Modernization Act.

He suggested Congress should ideally complete the legislation by June or July, leaving time to resolve disagreements before the statutory deadline.

Grossman also predicted renewed bipartisan support for FDA, NIH, CDC and vaccination programs, although he cautioned that Democratic ambitions to restore Medicaid funding and Affordable Care Act subsidies would face substantial fiscal and political obstacles.

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Ex-HHS Aide Says Overton Pressured Makary Over Vaccine Approval

Novocure Gets Rejection Letter on Lung Cancer Device

FDA Posts 18 Form 483 Inspection Records

FDA Orders Eye Safety Warnings for All GLP-1 Drugs