July 11, 2022
For the first time, a pharmaceutical company has asked for permission to sell a birth control pill over the counter in the U.S.
HRA Pharma’s application on Monday 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 Supreme Court’s recent decision overturning Roe v. Wade.
Hormone-based pills have long been the most common form of birth control in the U.S., used by millions of women since the 1960s.
They have always required a prescription, generally so health professionals can screen for conditions that raise the risk of rare, but dangerous, blood clots.
The French drugmaker’s application compiles years of research intended to convince the Food and Drug Administration that women can safely screen themselves for those risks and use the pill effectively
“For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available,” said Frederique Welgryn, HRA’s chief strategy officer.
An FDA approval could come next year and would only apply to HRA’s pill, which would be sold under its original brand name, Opill.
The company acquired the decades-old drug from Pfizer in 2014, but it’s not currently marketed in the U.S.Reproductive rights advocates want to see other prescription contraceptives move over the counter and, eventually, for abortion pills to do the same.
That potential for a precedent-setting decision once again places the FDA under an intense political spotlight.
The FDA is required to hold a public meeting to evaluate HRA’s application before making a decision.
Safety considerations are likely to take center stage.
Executives at HRA, which is owned by Perrigo Co., expect a decision in the first half of 2023.
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