Last Updated on July 13, 2022 by The Health Master
Washington: Amid the US Supreme Court’s decision to ban abortion in the country, the Food and Drug Administration (USFDA) is considering approving the first-ever over-the-counter (OTC) birth control pill.
Two companies—French drugmaker HRA Pharma and US-based Cadence Health—have approached the USFDA to authorize their pills for OTC sales in the US.
HRA Pharma has applied for an Rx-to-OTC switch for Opill, a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill).
In the statement, Frederique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma said, “This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the US.”
“More than 60 years ago, prescription birth control pills in the US empowered women to plan if and when they wanted to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers,” Welgryn added.
The pill has already been approved for use in the US since 1973, but only with a prescription. If approved, this would be the first daily birth control pill available OTC without a prescription in the US, the company said in a statement.
The New York Times reported that Cadence, whose pill is a combination of progestin and estrogen, plans to submit an application in the coming year.
While both companies have been in discussions with the USFDA for years, the timing of the HRA Pharma application is “a really sad coincidence,” Welgryn told the media agency. “Birth control is not a solution for abortion access,” she stressed.
The USFDA is expected to take around 10 months to make a decision on HRA Pharma’s application.
Meanwhile, major medical organizations, including the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians, have expressed support for moving birth control pills OTC.
Earlier this year, the US House of Democrats also signed a letter to USFDA Commissioner Robert Califf requesting a “timely review” of applications to make birth control pills available OTC, and more than 100 Democrats have signed on to a bill to make health insurance companies cover the cost of OTC birth control, the media agency reported.
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