Among the myriad changes wrought by the Covid-19 pandemic, Food and Drug Administration advisory committee meetings to review medicines are “rarer and tougher” now, according to one Wall Street analyst.
Over the past year, just half of new drug applications taken to advisory committees were recommended for regulatory approval. That compares with 78% in 2019 and a rate of more than 80% in three of the four years before that, according to Cowen analyst Rick Weissenstein, who cited an analysis by the Prevision Policy consulting firm in an investor note.
Seems logical to me. Consider the ones that would have gone to Panel during a normal year. The ones highly likely to be approved didn’t go to panel in 2020, FDA didn’t bother and approved without AdCom. Hence the overall number dropped, and also the success rate dropped.
Since, logically, the likely winners were the ones (correctly) that went straight to approval.
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