UPDATED: How a pharma company bought 2 accelerated approvals — never ran confirmatory trials — and cashed in until FDA said stop
The whole premise of the FDA’s accelerated approval pathway rests on the idea that clinical benefit will be established after the approval, via a confirmatory trial, proving the drug was worth authorizing early on.
In many cases, the confirmatory trial does just that, confirming the benefits that seemed promising at first, while in others — 112 of the 253 drugs authorized under the accelerated pathway have not been confirmed as clinically effective, per this BMJ investigation — still need to fulfill their promise.
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