First-Ever OTC Birth Control Pill Submitted for FDA Review

In a first-time instance of this type of request for over-the-counter birth control pills, Perrigo company’s unit HRA Pharma has submitted an inquiry with the FDA for sale of a prescription contraceptive sold under the brand name Opill. The application comes closely on the heels of the U.S. Supreme Court’s controversial decision to overturn Roe v. Wade, restricting federally protected access to abortion.

The FDA will likely hold an advisory committee meeting for approval in the first half of 2023; a period of at least 10 months is conventional for this type of approval request. Iffath Abbasi Hoskins, the President of the American College of Obstetricians and Gynecologists, said, "We know that birth control is not a solution to abortion bans, as people need abortion care for many reasons." However, she noted that the pill could still help more people "control their own reproductive futures."

Become a Subscriber

Please purchase a subscription to continue reading this article.

Subscribe Now

Opill, a non-estrogen, progestin-only pill, has been a prescription-only drug since its FDA certification in the same year that Roe v. Wade initially passed. Perrigo says that scientific research shows that Opill and other progestin pills are both effective and safe for most women. In terms of other OTC availability, abortion rights activists have long advocated for mifepristone, which when taken with misoprostol triggers an abortion up to 10 weeks into a pregnancy.