Perrigo unit asks FDA to approve first ever OTC birth control pill

2:08 am Tuesday, July 12th, 2022

(Reuters) -Perrigo Company said on Monday its unit HRA Pharma has asked the U.S. Food and Drug Administration (FDA) to approve a daily birth control pill for over-the-counter (OTC) sale, the first such request for this type of contraception. The application from the HRA comes on the back of the U.S. Supreme Court’s decision in June to overturn the 1973 Roe v. Wade case that legalized abortion nationwide.

The contraceptive is currently a prescription drug sold under brand 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 timing is a bit coincidental. We have been working on that application for the last seven years,” Welgryn said.

The FDA declined to comment on the submission.

Meanwhile, Iffath Abbasi Hoskins, president of the American College of Obstetricians and Gynecologists, said the submission was a positive.

“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”.

Currently, the only contraception drugs available for women without a prescription are emergency oral pills that can be taken within three days after having unprotected sex.

Abortion rights activists have stepped up calls to make mifepristone, which in combination with misoprostol induces an abortion up to 10 weeks into a pregnancy, available OTC.

The non-estrogen Opill has been used with prescription since it was FDA-approved in 1973. Perrigo said scientific evidence has shown progestin-only pills, such as Opill, are effective at preventing pregnancy and safe for most women to use.

(Reporting by Leroy Leo in Bengaluru; Editing by Krishna Chandra Eluri and Shinjini Ganguli)