FDA considers over-the-counter birth control pill approval


The United States Food and Drug Administration (FDA) is considering approving the first-ever over-the-counter birth control pill.

Two companies – French drugmaker HRA Pharma and US-based Cadence Health – have approached the FDA to approve their pill for OTC sale in the US

HRA Pharma has requested an Rx-to-OTC switch for Opill, a progestogen-only daily birth control pill (also known as the minipill or non-estrogen pill).

The pill has been approved in the USA since 1973, albeit on prescription. If approved, it will be the country’s first daily OTC birth control pill, the company said in a statement.

“This historic application marks a landmark moment for contraceptive access and reproductive equity in the United States,” said Frederique Welgryn, HRA Pharma’s chief strategic operations and innovation officer, in the statement.

“More than 60 years ago, prescription birth control pills in the United States gave women the power to plan if and when they wanted to conceive. Switching a safe and effective prescription birth control pill to OTC will help even more women and people gain access to birth control without unnecessary barriers,” Welgryn added.

Cadence, whose pill is a combination progestin and estrogen, plans to submit an application in 2023, the New York Times reported.

While both companies have been in talks with the FDA for years, the timing of the HRA-Pharma filing is “a really sad coincidence,” Welgrynt told The Times. “Birth control is not a solution to access to abortion,” she said.

According to media reports, the FDA is expected to take approximately 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 the switch from birth control pills to OTC.

Earlier this year, Democrats in the US House of Representatives signed a letter to FDA Commissioner Robert Califf asking for a “timely review” of applications for OTC availability of birth control pills. More than 100 Democrats have approved a bill that would require health insurance companies to cover the cost of OTC birth control, The Times reported.

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