A drugmaker seeks FDA approval for an over-the-counter birth control pill

Health News Florida | By Associated Press

Published July 11, 2022 at 3:34 PM EDT

The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. A drug company is seeking U.S. approval for the first-ever birth control pill that women could buy without a prescription. The request from a French drugmaker sets up a high-stakes decision for the FDA amid the political fallout from the Supreme Court's recent decision overturning Roe v. Wade.

A drug company is seeking U.S. approval for the first birth control pill that women could buy without a prescription.

The request from a French drugmaker HRA Pharma on Monday sets up a high-stakes decision for the Food and Drug Administration amid the political fallout from the Supreme Court's recent decision overturning Roe v. Wade.

The company says the timing was unrelated to the Roe decision.

If the FDA grants the request, women would be able to buy the pill over the counter, similar to common pain relievers. An FDA approval could come next year and would only apply to HRA’s pill, which would be sold under its original brand name, Opill.

Birth control pills are available without a prescription in many parts of the world.

The application compiles years of research intended to convince the FDA that women can safely screen themselves for those health risks and use the pill effectively.

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