FDA to consider pharma company’s application for over-the-counter birth control pill

Drugmaker HRA Pharma is seeking approval from the U.S. Food and Drug Administration (FDA) to sell an over-the-counter birth control pill in the U.S.

HRA Pharma, which is owned by Perrigo Co., submitted an application Monday to sell Opill, a prescription progestin-only daily birth control pill, as an over-the-counter medication. The company acquired the decades-old drug from Pfizer in 2014, but it is not currently marketed in the U.S.

If the company gets approval from the FDA, which could come by next year, it would mark the first over-the-counter daily birth control pill available without a prescription in the U.S., according to Perrigo.  

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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.

HRA, based in France, said Monday that removing the prescription requirement would improve access to the contraceptive method, which is "more effective at preventing pregnancy than all current methods" that are available over the counter.  

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"For many, a birth control pill may be the best option for them but requiring a prescription is an unnecessary obstacle that can put it out of reach," obstetrician-gynecologist Melissa Kottke said in a statement. "Removing the prescription requirement for a progestin-only birth control pill will be a historic advancement for pregnancy prevention and a remarkable achievement in community public health." 

HRA's application comes amid legal and political battles over women’s reproductive health. However, the company started gathering data necessary to submit the application to the FDA seven years ago. 

The company told FOX Business that the news happened to come after the recent Supreme Court decision to overturn Roe V. Wade and that the timing was unintentional.

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The FDA is required to hold a public meeting to evaluate HRA’s application before making a decision. However, HRA executives expect a decision in the first half of 2023.

The FDA told FOX Business that it cannot comment on pending applications or its interactions with manufacturers about their investigational products. 

The Associated Press contributed to this report.