Over-the-counter contraceptive? Drugmaker Seeks FDA Approval | News, Sports, Jobs

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WASHINGTON (AP) – For the first time, a pharmaceutical company has applied for permission to sell an over-the-counter birth control pill in the United States.

HRA Pharma’s Monday request sets up a high-stakes decision for health regulators amid legal and political battles over women’s reproductive health. The company says the timing was unrelated to the recent Supreme Court decision overturning Roe v. Wade.

Hormone pills have long been the most common form of birth control in the United States, used by millions of women since the 1960s. They have always required a prescription, usually so medical professionals can screen conditions that increase the risk of rare but dangerous blood clots.

The French drugmaker’s app compiles years of research aimed at convincing the Food and Drug Administration that women can safely screen themselves for these risks and use the pill effectively.

“For a product that has been available for 50 years, that has been used safely by millions of women, we thought it was time to make it more available,” said Frédérique Welgryn, chief strategy officer of HRA.

An FDA approval could come next year and would only apply to HRA’s pill, which would be sold under its original brand, Opill. The company acquired the decades-old drug from Pfizer in 2014, but it is not currently marketed in the United States.



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