FDA to consider ‘mini’ over-the-counter birth control pill

The Food and Drug Administration is set to evaluate an application for what would be the first over-the-counter birth control pill. French pharmaceutical company HRA Pharma said Monday that it has formally asked the FDA to authorize its contraceptive.

The submission comes as the United States is grappling with a fast-changing reproductive healthcare landscape after the Supreme Court ended federal protections for abortion. Justice Clarence Thomas wrote in a Supreme Court opinion that the court should reconsider opinions on rights to contraception. The timing is a coincidence, Frédérique Welgryn, HRA Pharma’s chief strategic operations and innovations officer, told The New York Times. “Birth control is not a solution for abortion access,” she said. But an over-the-counter birth control pill would help remove barriers to contraception, she said in a statement.

Rare side effects of birth control pills can include blood clots, and some people with medical conditions that increase their risk of clots (like history of stroke) aren’t recommended to take them. That’s one reason they’ve required a prescription.

HRA Pharma’s birth control is a “mini pill” — it only contains the hormone progestin rather than a combination of progestin and estrogen. The mini pill is less commonly used in the United States, and people have to be careful to take it at the same time every day. But because it doesn’t contain estrogen, it doesn’t increase the risk of blood clots or stroke.

Organizations like the American Medical Association (AMA) support an over-the-counter birth control pill. “Providing patients with OTC access to the birth control pill is an easy call from a public health perspective as the health risks of pregnancy vastly outweigh those of oral contraceptive use,” said AMA board member David Aizuss in a statement.

Another pharmaceutical company, Cadence Health, is also working toward an over-the-counter birth control pill. Its pill is a combination of progestin and estrogen. Both companies have been in discussions with the FDA for years.

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