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.
NBC News:
FDA Appears Skeptical About Over-The-Counter Birth Control Pill
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’s 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)
Bloomberg:
Birth Control Pill Over The Counter Faces FDA Concerns, PRGO Shares Fall
Opill may not be effective as a nonprescription pill given Americans’ 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. (Rutherford, 5/5)
In related news about reproductive health care —
AP:
Abortion Pill Legal Challenge Threatens Miscarriage Care
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 “off label” 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’t challenging uses of the drug beyond abortion. But legal experts say if it’s taken off the market for its approved use, it wouldn’t be available for pregnancy loss. (Ungar, 5/6)
Stat:
Community Baby Showers Offer Prenatal Care And More
The Bronx auditorium was bustling with pregnant people, and Detective Fred Washington of the police department’s community affairs bureau had a promise. “If anyone goes into labor, NYPD is here to help!” 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’s 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)
