FDA mulls approval for over-the-counter birth control pill


The United States Food and Drug Administration (FDA) is considering to approve the first-ever over the counter (OTC) birth control pill.

Two companies – French drugmaker HRA Pharma and US-based Cadence Health – have approached the FDA to authorize their pill for OTC-sales in the U.S.

HRA Pharma has applied for an Rx-to-OTC switch for Opill, a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill).

The pill has already been approved for use in the U.S. since 1973, but with a prescription. If approved, this will be the country’s first daily OTC birth control pill, the company said in a statement.

“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.,” said Frederique Welgryn, chief strategic operations and innovation officer at HRA Pharma, in the statement.

“More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers,” Welgryn added.

Cadence, whose pill is a combination of progestin and oestrogen, plans to submit an application in 2023, The New York Times reported.

While both companies have been in discussions with the FDA for years, the timing of the HRA Pharma application is “a really sad coincidence,” Welgryntold The Times. “Birth control is not a solution for abortion access,” she stressed.

The FDA is expected to take around 10 months to make a decision on HRA Pharma’s application, media reports said.

Meanwhile, major medical organizations, including the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians, have expressed support for moving birth control pills OTC.

Earlier this year, Democrats in the U.S. House of Representatives signed a letter to FDA Commissioner Robert Califf requesting a “timely review” of applications to make birth control pills available OTC. More than 100 Democrats have signed onto a bill to make health insurance companies cover the cost of OTC birth control, The Times reported.