Letter from Free the Pill coalition to FDA Commissioner Dr. Robert M. Califf

Today, seven months after HRA Pharma announced its submission to the FDA of the first-ever Rx-to-OTC switch application for a progestin-only oral contraceptive pill, we are writing to express our frustration and disappointment at the FDA’s postponement of the advisory committee meeting to discuss this application as well as the lack of information that has been shared about next steps. The FDA announced the postponement of this meeting on October 26, 2022, and now, more than four months later, we have yet to receive any further communication as to when a new date will be set. The FDA must prioritize reviewing the first-ever application for an OTC birth control pill and announce a new date for the advisory committee meeting as soon as possible.
— Free the Pill coalition
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Experiences of progestin-only pill users in the United States and attitudes toward over-the-counter access

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The evidence supports over-the-counter access to progestin-only pills: A research summary