FDA approves first OTC birth control pill

July 13, 2023

The U.S. FDA has approved Perrigo's Opill, a progestin-only daily oral contraceptive, for over-the-counter use for all ages — marking the first ever OTC birth control pill available in the U.S.

"Today marks a truly momentous day for women's health nationwide," said Patrick Lockwood-Taylor, Perrigo president and CEO.

Although long-anticipated, the agency's decision was not a surprise. Back in May, the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC) voted 17 to 0, with no abstentions, that the benefits of making Opill available for OTC use outweighed the risks.

Opill was first approved by the FDA in 1973 and marketed by Pfizer as the Rx product Ovrette, until it was discontinued for business reasons in 2005. French drugmaker HRA acquired the rights to Opill in 2015 with the intent to generate the data necessary to support a full Rx-to-OTC switch application, and Perrigo grabbed the reigns when it bought HRA Pharma last year.

Perrigo's HRA Pharma applied for an Rx-to-OTC switch for Opill back in July of last year. Then, in October, a month before a planned FDA advisory committee meeting, the agency postponed the meeting, as well as delayed the drug's PDUFA date for 90 days. 

Now, according to Perrigo, Opill will be available in stores and online in the first quarter of next year. The company will share information on pricing and distribution plans in advance.

Assuring access to reproductive health drugs has been top of mind for drugmakers since the Supreme Court overturned Roe v. Wade last June. While most of the controversy has been focused on the abortion drug, mifepristone, there is still a lingering concern that states could plunge further into the reproductive health space and seek out ways to restrict access to birth control.

Perrigo was one of two drugmakers pursuing an Rx-to-OTC switch for a birth control pill. In 2018, Cadence OTC bought the rights to two estrogen-progesterone combo oral contraceptives, Lo/Ovral and Alesse, from Pfizer. The company is currently focused on consumer label pivotal studies for its OTC pill, branded as Zena.