F.D.A. to Weigh Over-the-Counter Sale of Contraceptive 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 to supply a birth control pill 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. submission, 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.
https://www.msn.com/en-us/news/politics/fda-to-weigh-over-the-counter-sale-of-contraceptive-pills/ar-AAZrKwb
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