When History Has Its Eyes On You: Opill Vote Puts US FDA In Tough Spot
A unanimous US FDA advisory committee vote in favor of a landmark decision to make oral contraceptives available without a prescription should be history in the making. But the desire to make history – rather than address FDA’s significant concerns with the actual application for Perrigo’s Opill – seems to have carried the day.
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FDA officials again made clear concerns about “improbable dosing” data in HRA’s sNDA for 0.075-mg norgestrel tablet branded Opill before advisory panel voted at close of a two-day meeting conducted 60 years after first Rx oral contraceptive approved in US.
With “improbable dosing in approximately 1/3 of participants” in HRA actual use study, FDA asks advisory committees to recommend design changes if it asks firm for another study. FDA asked HRA to explain discrepancies after it began reviewing the firm’s sNDA submitted in June 2022.
Overall survival is the only viable endpoint for pragmatic trials in oncology, the US FDA and a panel of stakeholders agree, although other novel endpoints could be validated over time. In the meantime, FDA says, sponsors should focus on other aspects of trials that can be streamlined.