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# Democratic Congress Could Complicate User Fee Reauthorization
- URL: https://www.fdaweb.com/democratic-congress-could-complicate-user-fee-reauthorization/
- Published: 2026-11-06T18:11:30.000Z
- Updated: 2026-11-06T18:11:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General

FDA officials remain confident that Congress will reauthorize the agency's four major user fee programs before they expire next September, although Democratic control of Congress and the prospect of Sen. **Bernie Sanders** (I-VT) chairing the Senate HELP Committee could complicate the reauthorization over the already-negotiated agreements.

Speaking 11/4 at the Association for Accessible Medicines' GRx+Biosim conference, FDA acting chief of staff **Lowell Zeta** cited longstanding bipartisan support for the programs, which fund substantial portions of FDA's drug, generic drug, biosimilar and medical device review operations.

“There’s been great bipartisan support for the user fee programs,” Zeta said, according to [Regulatory Focus](https://www.raps.org/resource/fda-official-expects-user-fee-reauthorization-despite-midterm-shakeup.html?ref=fdaweb.com). He expressed confidence that Congress would approve the agreements covering fiscal years 2028–2032 despite changes in congressional leadership following the midterm elections.

However, [STAT reported 11/4](https://www.statnews.com/2026/11/04/bernie-sanders-senate-help-key-role-pdufa-reauthorization/?ref=fdaweb.com) that Sanders' anticipated leadership of the HELP Committee could introduce significant complications. Sanders has long criticized FDA's reliance on pharmaceutical industry user fees, arguing that the funding arrangement creates potential conflicts of interest. He opposed prescription drug user fee reauthorization legislation in 2007, 2012 and 2017, although he supported the most recent reauthorization in 2022.

According to STAT, Sanders could seek to use the legislation to advance additional pharmaceutical policy and reform measures, potentially involving drug pricing, prescription drug advertising and FDA oversight. Such provisions could broaden reauthorizations beyond the agreements already developed between FDA and industry.

Rep. **Frank Pallone** (D-NJ), who is positioned to chair the House Energy and Commerce Committee, has generally supported the user fee programs but has previously used reauthorization legislation to advance FDA reforms, including changes to accelerated approval oversight. 

One provision that may draw Congressional scrutiny is a 50% application fee reduction for sponsors submitting qualifying U.S.-based Phase 1 clinical trial data.

In an 11/6 [American Action Forum analysis](https://www.americanactionforum.org/weekly-checkup/the-2026-midterms-and-health-policy/?ref=fdaweb.com), health policy director **Michael Baker** said questions involving FDA accountability, evidentiary standards, review capacity and agency operations could receive greater attention as Congress considers the reauthorization package.

Baker also noted uncertainty over Republican leadership of the Senate HELP Committee following Chairman **Bill Cassidy**'s (R-LA) primary defeat and other Republican election losses. The committee's eventual Republican leadership and membership could influence which FDA and pharmaceutical policy priorities receive bipartisan support, he said.

Despite the potential disagreements, the programs have historically received bipartisan support. The central uncertainty is whether the new congressional leadership will seek substantial policy concessions as part of the reauthorization process, rather than whether the programs themselves retain support.