FDA Approves First OTC Oral Contraceptive

The FDA announced today that it had approved Opill (norgestrel), the first over-the-counter oral contraceptive.

The decision was heralded by Planned Parenthood. “Access to birth control pill over-the-counter breaks down the barriers people face to prescription methods, like the costs & variability of a doctor’s appointment, transportation, and insurance coverage,” the organization tweeted.

CVS has already promised to sell Opill at its 10,000 locations, Politico reported.

Norgestrel consists of progestin, a synthetic form of progesterone, a naturally occurring hormone. It works as a birth control pill by preventing ovulation.

The FDA's media release about the approval says that the contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973.The agency said in a related information sheet that norgestrel has not been available in the U.S. since 2005 in because of the manufacturer’s decision to stop selling the drug for business reasons.

HRA Pharma, a French company, applied to switch norgestrel from a prescription to an over-the-counter product. Perrigo Company plc, which is registered in Ireland but has a large North American headquarters in Grand Rapids, Michigan, acquired Opill in May 2022 when it bought HRA Pharma in a $1.9 billion deal.

The New York Times reported today that the pill probably won’t be available in stores or online until early next year. The newspaper said the company did not disclose a price but quoted a company official as saying it would be accessible and affordable.

The FDA’s information sheet about Opill says it must be taken every day and at the same time, or the effectiveness is reduced. The agency said it should not be taken by women who have or have had breast cancer or together with other birth control pills, a vaginal ring, patch, implant, injection or an intrauterine device (IUD). The agency also said Opill should not be used as an emergency contraceptive.