FDA user fee reauthorizations turn into rare bipartisan lovefest at House hearing
Leaving any hint of partisanship to the dust, the subcommittee on health of the House’s energy and commerce committee came together across both sides of the aisle to support not only the user fee reauthorizations that provide for the majority of FDA’s budget, but also the add-on bills that would reform the agency’s accelerated approval pathway among other measures.
On the accelerated approval front, the bill, which advanced to the full committee next week by a unanimous vote of 30-0, would allow the FDA to require confirmatory trials to be underway prior to granting these approvals as part of reforms to shore up companies that drag their feet on such trials. It would also streamline the FDA’s ability to withdraw accelerated approvals when confirmatory trials fail, and it requires the agency to explain itself when not requiring a confirmatory trial.
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