F.D.A. to Weigh Over-the-Counter Sale of Birth Control Pills

WASHINGTON — More than 60 years after the approval of oral contraceptives revolutionized women’s sexual health, the Food and Drug Administration has received its first application for a birth control pill sold over the counter — just as the Supreme Court’s decision to overturn Roe v. Wade has put access to contraception more squarely at the heart of the clash over reproductive rights.

A Paris-based company, HRA Pharma, announced on Monday that it had asked the F.D.A. to authorize its pill, which is available by prescription, for over-the-counter-sales in the United States. Cadence Health, another pill manufacturer that has been in close dialogue with the F.D.A. about switching its pill to over-the-counter status, said it hopes to move closer to submitting an application in the coming year.

The timing of HRA Pharma’s F.D.A. application, just weeks after the Supreme Court decision, is “a really sad coincidence,” said Frédérique Welgryn, the company’s chief strategic and innovations officer. “Birth control is not a solution for abortion access,” she said.

Under ordinary circumstances, filing an application to sell a prescription drug over the counter might go unnoticed in Washington. But birth control is a delicate issue for the F.D.A. Cadence and HRA Pharma have been mired for years in the agency’s pre-application process, and HRA’s formal application comes at an especially fraught moment in the campaign for reproductive rights.

The Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, which struck down Roe and eliminated the constitutional right to abortion, included a concurring opinion by Justice Clarence Thomas suggesting that the 1965 decision that established a right to contraception should also be overturned. On Friday, President Biden denounced the Dobbs ruling as “an exercise in raw political power,” and vowed to expand access to reproductive health care.

On Capitol Hill, scores of House Democrats signed a letter this year to Dr. Robert M. Califf, the F.D.A. commissioner, requesting a “timely review” of any applications to take birth control pills over the counter. More than 100 Democrats have signed on to a bill requiring insurance companies to cover the cost of over-the-counter birth control. (The Affordable Care Act requires it, but federal regulations allow insurers to insist on a prescription before paying for an over-the-counter product.)

“As we are seeing the outfall and the chaos of the Supreme Court decision, more families are looking to, ‘Well, how can I make sure I control my own choices in life?’” said Senator Patty Murray, Democrat of Washington, the chairwoman of the Senate Health Committee and the lead sponsor of the measure. “We want to make sure that women not only get access, but those who have trouble affording it get access as well.”

HRA Pharma officials said they expect an F.D.A. decision in about 10 months, which is typical for over-the-counter applications. The F.D.A. declined to comment.

Supporters of reproductive rights are also calling on Mr. Biden to have the F.D.A. move quickly on its review of over-the-counter contraceptives in light of the…