House Subcommittee Schedules Hearing on PDUFA, GDUFA and BsUFA Reauthorizations

The House Energy and Commerce Health Subcommittee will hold a hearing Thursday on reauthorizing FDA user fee programs for prescription drugs, generics and biosimilars, ahead of the programs’ expiration slated for Sept. 30.

The lawmakers will hear testimony from high-ranking FDA officials and stakeholders in the hearing, which is scheduled to start at 10:30 a.m. ET.

In mid-January, the FDA submitted its user fee commitments negotiated with industry to lawmakers, allowing Congress to start work on legislation to reauthorize the programs for fiscal years 2023 through 2027.