Accelerated Approval Reforms Give US FDA More Power And Flexibility – With Some Gaps
Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.
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Rejecting company’s appeal, CBER Director Peter Marks says the multiple myeloma drug should be withdrawn because its confirmatory trial failed to verify clinical benefit and evidence demonstrates the drug is not safe and effective for its current indication.
FDA Commissioner Robert Califf said pharma should not be the sole entity handling postmarket research.
Biogen faces complex logistics in shutting down a multinational trial with more than 200 sites and approximately 1,000 patients enrolled; company also is facing calls to publish data collected from the unfinished study as well as other aducanumab trials.