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Cloud Over FDA Advisory Panel Meeting From ‘Over-Reporting’ In Birth Control OTC Switch Study

 
• By Malcolm Spicer

While HRA consultant says its study “meets or exceeds standards of most other studies assessing adherence, including an oral contraceptives,” FDA ONPD director says particpants’ over-reporting “is not something we see in a typical actual use study.”

• Source: Shutterstock

The US Food and Drug Administration is holding the line on requiring reliable data supporting an OTC switch application no matter how much and how often the sponsor describes the numerous public health benefits of expanding access to a daily oral contraceptive.

Agency officials, on 9 May during the first day of a two-day advisory panel meeting conducted online, also heard almost unanimously from consumers and representatives of medical and advocacy groups recommending approval of HRA Pharma’s supplemental new drug application to allow OTC sales of Opill (0.75-mg norgestrel)

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