Why does the FDA select certain drugs for adcomm meetings? Researchers want to know
Although their numbers have dwindled in recent years, FDA advisory committees have been in the spotlight, and some experts are now seeking reforms to make them more useful, including a trio of leaders from Harvard’s Program on Regulation, Therapeutics, and Law writing in the New England Journal of Medicine.
The perspective explains the way in which the FDA typically follows the guidance from its adcomm, although about once annually, it doesn’t, and those missed connections can lead to major blunders, as in the case of Biogen’s new Alzheimer’s drug aducanumab, which won approval via the accelerated pathway after no adcomm members voted in favor of its full approval, but then failed to obtain coverage from CMS, which requested additional randomized trials.
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