Bernie Sanders Set to Influence PDUFA Renewal as Senate HELP Chair After Midterms

The 2026 midterm results shift control of key Senate health levers to Democrats, elevating Sanders, a longtime critic of industry user fees, into a pivotal negotiating role. PDUFA, first enacted in 1992 and renewed every five years, expires September 30; without reauthorization the FDA loses authority to collect fees that support review staff. Sanders has repeatedly argued the structure creates regulatory capture, citing past instances where performance goals tied to fee payments compressed review timelines.

Historical data show user fees rose from 27 percent of the drug center budget in 1993 to 65 percent by 2023, per FDA congressional budget justifications. This shift coincided with faster approvals but also drew scrutiny in observational analyses linking fee reliance to higher rates of post-market safety withdrawals. Sanders has signaled intent to increase direct appropriations, a change that would require offsetting cuts elsewhere or higher deficits.

Industry groups warn that reduced fee revenue could delay staffing and slow approvals by 20-30 percent based on internal FDA contingency models. Sanders has proposed tying any new funding to stricter conflict-of-interest rules and expanded post-approval surveillance. Negotiations begin in early 2027; the outcome will test whether Congress can sustain review capacity while altering the funding ratio.

The next step is markup of a Senate bill by June 2027, where Sanders can offer amendments to cap industry fees at 45 percent of the review budget.