FDA Considering Over-the-Counter Birth Control Pill

The Food and Drug Administration (FDA) has its first application from a pharmaceutical company to sell a birth control pill over the counter.

French drugmaker HRA Pharma filed the application Monday even as protest and debate over the Supreme Court’s overturning of Roe v. Wade continues. Critics charge that access to contraception may also be limited after the ruling.

Though it will take months or longer for the application to go through the FDA’s process, the company notes the historic first for women. In a statement, HRA Pharma executive Frederique Welgryn called it a “groundbreaking moment in contraceptive access and reproductive equity.”

The company said there is no relation between the timing of its application and the Supreme Court ruling.

The FDA may see some political blowback from the application, but most anti-abortion groups say they are not interested in contraceptive issues. Specific state bans enacted since Roe’s overturning have pointedly excluded contraception.

Opill, as the product is called, would be the first hormonal birth control pill available without a prescription in the country. HRA Pharma said over six years of testing have gone into proving the medication is safe and effective.

The company’s efforts were funded in part by the Oral Contraceptives Over-The-Counter Working Group. This coalition of advocates and researchers pushes for more access to birth control for those with less health care access.

A national study showed that a significant number of women who want access to contraceptives are limited. Almost 30% have barriers that include lack of health insurance, transportation issues to a clinic or pharmacy, or not having a personal doctor.

A different study compared women who obtained birth control pills over the counter in Mexico to those who get them with a prescription in the U.S. It found that the over-the-counter users were more likely to keep taking them long term.

Approval for the HRA pill in the U.K. was granted last year. Various brands are also available without a prescription in South America, Asia, and Africa.

For an administration facing enormous pressure from activists over the end of Roe, having the easily available birth control pill approved would be a notable success. There have been demonstrations at the White House and elsewhere urging President Joe Biden to “free the pill.”