Generally, drugmakers must show that consumers can accurately understand and follow the labeling instructions to safely and effectively use the drug. Many common medications have made the over-the-counter switch, including drugs for pain relief, heartburn and allergies. Birth control pills are available without a prescription across much of South America, Asia and Africa. but is sold without a prescription in the U.K.įDA’s decision won’t apply to other birth control pills, only Opill, although advocates hope that an approval decision might push other pill makers to seek over-the-counter sales. Perrigo acquired rights to the drug last year with its buyout of Paris-based HRA Pharma, which bought the pill from Pfizer in 2014. Hormone-based pills, like Opill, have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s.

If the agency grants the company’s request, Opill would become the first contraceptive pill to be moved out from behind the pharmacy counter onto store shelves or online.įriday’s FDA review suggests regulators have serious reservations about broad access to the drug, including whether younger teenagers will be able to correctly follow the labeling directions. The two-day public meeting is one of the last steps before a final FDA decision. The agency also noted signs that study participants had trouble understanding the labeling instructions.Īdvisers to the FDA meet next week to review drugmaker Perrigo’s application. The FDA cited problems with the reliability of some of the company’s data on the drug, Opill, and questioned whether women with certain other medical conditions would correctly opt out of taking it. health regulators are weighing the first-ever request to make a birth control pill available without a prescription.īut in an initial review posted Friday, the Food and Drug Administration raised numerous concerns about drugmaker Perrigo’s application to sell its decades-old pill over the counter.

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