FDA is reviewing first ever over-the-counter birth control pill.

The non-estrogen Opill has been used with prescription since it was FDA-approved in 1973.



The first request for this kind of contraception was made by Perrigo Company's unit HRA Pharma, which revealed on Monday that it has petitioned the US Food and Drug Administration (FDA) to authorize a daily birth control pill for over the counter (OTC) sale. The Roe v. Wade ruling from 1973, which made abortion legal worldwide, was overturned by the US Supreme Court in June, prompting the HRA to submit its application. Currently, the contraceptive is a prescribed drug marketed under the name Opill. HRA Pharma expects the regulator to hold an advisory committee meeting and approve the application in the first half of 2023, a period of about 10 months is typical for such approval requests, said Frédérique Welgryn, HRA Pharma's chief strategic operations and innovation officer.


The submission was a success, according to Iffath Abbasi Hoskins, president of the American College of Obstetricians and Gynecologists. "We know that birth control is not a solution to abortion bans, as people need abortion care for many reasons," Hoskins said, but added that the pill could still help more people to "control their own reproductive futures". Emergency oral tablets, which must be taken three days after unprotected sex, are the only contraceptives currently available to women without a prescription. Since the FDA approved the non-estrogen Opill in 1973, it has been used on a prescription basis. According to Perrigo, research has demonstrated that progestin-only medications, like Opill, are safe for the majority of women to take and effective at preventing pregnancy.