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House panel announces user fee hearings
House Republicans on Thursday announced a slew of hearings on health industry fees aimed at speeding up federal regulators' review of new medicines before they can go to market.
The Energy and Commerce health subcommittee will kick things off on Feb. 1 with a hearing on the Prescription Drug User Fee Act, which expires Sept. 30. Food and Drug Administration Commissioner Margaret Hamburg is scheduled to testify at the hearing.
On Feb. 7 the panel has scheduled a hearing on a new proposed user fee on generic drugs and biosimilars, which aims to bring in more funds to help alleviate the FDA's backlog of generic drug applications. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, is scheduled to testify at the hearing.
And on Feb. 15, the subcommittee has scheduled a hearing on the reauthorization of the Medical Device User Fee Act, which also expires Sept. 30. FDA Center for Devices and Radiological Health Director Jeffrey Shuren is due to testify at the hearing.
The FDA struck a preliminary agreement with drugmakers in May over the prescription drug fee reauthorization, which is expected to sail through Congress. The deal calls for a $100 million increase in fees to pay for more than 100 extra staff members, two more meetings with sponsors during the drug review process and a two-month extension of the review time for new drugs.
The medical device fee is shaping up to be a tougher sell. Device makers want a revamp of the expedited approval process for low-risk devices, but patient advocacy groups say the current system is already too lax and allows dangerous products to get to market with little to no oversight.
