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This Tuesday, May 9th, NASPAG was one of 37 different organizations and/or individuals to speak at the Open Public Hearing session of the joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee of the FDA. The Advisory Committee was assembled to review the application from HRA Pharma for a "prescription-to-OTC" switch for Norgestrel 0.075mg (Opill) as a progestin-only oral contraceptive. Speakers included several major medical societies, reproductive justice and advocacy organizations, and many youth who boldly shared their personal stories! Out of the 37 speakers, 35 spoke in strong support of the proposal. Our Advocacy Committee has been hard at work advocating for this proposal. Shelby Davies, Olga Kciuk and Nichole Tyson attended a confidential briefing by HRA Pharma prior to the public hearing and Shelby Davies spoke on behalf of NASPAG at the public hearing. She shared the remarks previously published by NASPAG, which can be found at the following link: Click Here to View
Wednesday, May 10th, the FDA advisory committee voted UNANIMOUSLY to recommend the FDA bring the Opill over-the-counter with no age restrictions. This was a huge victory but there is still more work to be done! The vote was by a panel of experts assembled by the FDA. It was NOT a decision by the FDA. It could take months for the FDA to officially approve allowing the Opill to be sold over-the-counter. It is also possible that the FDA could include an age restriction despite the recommendation of the advisory committee. NASPAG will keep advocating for this issue! For more information, please see the following information, including some live tweets from the day of the hearing! Wednesday, May 10th, the FDA advisory committee voted UNANIMOUSLY to recommend the FDA bring the Opill over-the-counter with no age restrictions. This was a huge victory but there is still more work to be done! The vote was by a panel of experts assembled by the FDA. It was NOT a decision by the FDA. It could take months for the FDA to officially approve allowing the Opill to be sold over-the-counter. It is also possible that the FDA could include an age restriction despite the recommendation of the advisory committee. NASPAG will keep advocating for this issue! Day 1 livetweet thread (May 9): Look for a shoutout to Dr. Shelby Davies on this one! https://twitter.com/RewireNewsGroup/status/1655928549860057088 Day 2 livetweet thread (May 10): https://twitter.com/RewireNewsGroup/status/1656290632405483521 Dr. Daniel Grossman (UCSF) has some great screenshots: https://twitter.com/DrDGrossman/status/1655931328926449667 The Free The Pill coalition has been tweeting links to many of the societies’ statements, including:
Here’s a 3min NPR listen: And the meeting itself is available here. |
