U.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription.
This illustration provided by Perrigo in May 2023, depicts proposed packaging for the company's birth control medication Opill. Advisers to the Food and Drug Administration meet next week to review drugmaker Perrigo's application to sell a decades-old pill over the counter.
But in an initial review posted Friday, the FDA raised numerous concerns about studies of Opill, citing problems with the reliability of some of the company’s data and questions about whether women with certain other medical conditions would correctly opt out of taking it. It also noted signs that study participants had trouble understanding the labeling instructions.The agency will ask the panel to consider whether younger teenagers will be able to understand and follow the instructions.
“We have no doubt that our data clearly shows that women of all ages can safely use Opill in the over-the-counter setting,” Frederique Welgryn, the company’s global vice president for women’s health, said this week. Opill was first approved in the U.S. 50 years ago. Perrigo acquired rights to the drug last year with its buyout of Paris-based HRA Pharma, which bought the pill from Pfizer in 2014. It’s not currently marketed in the U.S. but is sold without a prescription in the U.K.
Women were paid to track and record their use of the pill, including whether they followed instructions to take it during the same 3-hour window each day. That consistency is key to the drug’s ability to block pregnancy. The most popular birth control pills today contain the synthetic hormone progestin, which helps block pregnancy, plus estrogen. The addition of estrogen can help make periods lighter and more regular but it also carries the risk of rare blood clots.
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