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Monday, May 8 2023

Full Issue

FDA Review Outlines Concerns About Approving First OTC Birth Control

An assessment by FDA scientists says that data may be insufficient in order for the agency to authorize over-the-counter sales of HRA Pharma's Opill. If the FDA were to approve, it would become the first oral birth control to be available without a prescription in the U.S.

Food and Drug Administration scientists on Friday expressed skepticism about whether the birth control pill can be switched from prescription to over-the-counter. The assessment by FDA staff, included in briefing documents published Friday, comes ahead of a two-day meeting scheduled for next week, when the agency鈥檚 advisers will vote on whether to recommend that the agency allow a birth control pill called Opill to be sold over-the-counter. (Lovelace Jr., 5/5)

Opill may not be effective as a nonprescription pill given Americans鈥 increasing body weight, regulators said in briefing documents. Staff also cited major limitations in crucial data submitted by the company in support of an over-the-counter switch.聽(Rutherford, 5/5)

In related news about reproductive health care 鈥

A million U.S. women a year suffer miscarriages, which occur in at least 15% of known pregnancies. Mifepristone was approved in 2000 for early abortions but it is often used 鈥渙ff label鈥 to treat early pregnancy loss or to speed up delivery when a fetus dies later in pregnancy. These uses are so common that U.S. senators urged manufacturer Danco to apply to the FDA to add miscarriage to the label of its drug, Mifeprex. Denise Harle, an attorney for the group that filed the Texas lawsuit on behalf of anti-abortion doctors and health care organizations, said they aren鈥檛 challenging uses of the drug beyond abortion. But legal experts say if it鈥檚 taken off the market for its approved use, it wouldn鈥檛 be available for pregnancy loss. (Ungar, 5/6)

The Bronx auditorium was bustling with pregnant people, and Detective Fred Washington of the police department鈥檚 community affairs bureau had a promise. 鈥淚f anyone goes into labor, NYPD is here to help!鈥 he shouted to the hundreds of people who had come from around the Bronx to the community baby shower to receive donated diapers, pacifiers, and children鈥檚 clothing. Along with the items, the showers have provided hundreds of expectant families with education on safe sleep, domestic violence, the importance of car seats, prenatal care, and more. (Jaques, 5/8)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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