Lawmakers Request PDUFA Timing Information From FDA

Two leading House members sent a letter to FDA Commissioner Andrew von Eschenbach asking him when he would have to alert agency employees about possible layoffs if the Prescription Drug User Fee Act (PDUFA) is not reauthorized.

House Committee on Energy and Commerce Chairman John Dingell (D-Mich.) and Subcommittee on Health Chairman Frank Pallone (D-N.J.) asked von Eschenbach to tell them the date by which the agency would have to issue a "reduction in force notice." Both lawmakers said they supported PDUFA's reauthorization and would work to have the committee pass it in time to prevent layoff notices.

The committee must understand the time frame the FDA needs so the agency can continue its work without major disruptions while waiting for funding from the bill, the letter said.

The FDA recently submitted its final recommendations for PDUFA reauthorization to Congress. The new proposal includes an $87.4 million increase in user fees over the current PDUFA, some of which is meant to hire new employees. The current version of the act expires Sept. 30.

Dingell also sent a letter this week to HHS Secretary Mike Leavitt about von Eschenbach's testimony at a House Subcommittee on Oversight and Investigations hearing on the antibiotic Ketek. Dingell, along with subcommittee Chairman Bart Stupak (D-Mich.), said the commissioner may have "intentionally misled" the subcommittee.

The lawmakers requested a response from the commissioner by April 17.

( http://www.fdanews.com/did/6_69/ )