A drugmaker seeks FDA approval for an over-the-counter birth control pill
If the FDA grants the request for HRA Pharma's Opill, women would be able to buy the pill over the counter, similar to common pain relievers.
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.