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FDA Mulling Over-the-Counter Sale of Contraceptive Pill

Application from HRA Pharma to make birth control more accessible comes just weeks after overturning of Roe v. Wade

MONDAY, July 11, 2022 (HealthDay News) — For decades, birth control pills in the United States have only been available with a prescription, but an application filed Monday with the U.S. Food and Drug Administration for an over-the-counter pill might change all that.

The latest effort to make birth control more accessible comes just weeks after the U.S. Supreme Court overturned Roe v. Wade.

Applicant HRA Pharma already sells its pill (Opill) in the United States as a prescription-only drug. But it is not the only company looking to go over-the-counter (OTC) with birth control pills: Cadence Health is also in talks with the FDA to do the same and said it plans to submit an application in the coming year, The New York Times reported. The timing of the HRA Pharma application is “a really sad coincidence,” Frédérique Welgryn, the company’s chief strategic and innovations officer, told The Times. “Birth control is not a solution for abortion access,” she stressed.

In his concurring opinion on the recent Supreme Court ruling, Justice Clarence Thomas suggested that the 1965 decision that provided a right to contraception should also be overturned. Meanwhile, President Joe Biden issued an executive order on Friday to offer continued abortion access across the United States, in an effort to curb the impacts of the court’s ruling.

Earlier this year, House Democrats signed a letter to FDA 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 Times reported.

HRA Pharma said it expects a decision from the FDA in the next 10 months, the typical waiting period for OTC applications.

The New York Times Article

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