Dates for PDUFA, MDUFA, GDUFA Committee Hearings Announced, Top FDA Officials to Testify

The Energy and Commerce Committee of the US House of Representatives announced Thursday that its Health Subcommittee will hold hearings on the Prescription Drug User Fee Act (PDUFA) reauthorization, Medical Device Use Fee (MDUFA) Act reauthorization, and the authorization of the Generic Drug User Fee Act (GDUFA).

The subcommittee will hold its first hearing on PDUFA on 1 February and call US Food and Drug Administration (FDA) Commissioner Margaret Hamburg to testify.

The subcommittee will hold a second hearing on 7 February to discuss the authorization of GDUFA, and will call Center for Drug Evaluation and Research Director Janet Woodcock to testify.

The subcommittee will hold a final hearing on 15 February regarding MDUFA, and call Center for Devices and Radiological Health Director Jeffery Shuren to testify.

PDUFA and MDUFA are both set to expire in September, making the prospect of any slowdown a dangerous one for FDA and pharmaceutical industry alike. FDA is expected to issue final recommendations on the PDUFA legislation on 15 January.

The legislation would cover FY2013-2017 and require more communication between FDA and industry.

• Health Subcommittee Announces Upcoming Hearings, Reauthorization Schedule for Medical Device and Drug User Fee Programs