medical groups, including the American Medical Association, support making the drugs available over the counter. But the FDA notes that half of women in Perrigo’s study who had unexplained bleeding incorrectly said Opill would be appropriate for them. And women who have unusual vaginal bleeding are instructed to talk to a doctor first, because it could indicate a medical problem. Women with a history of breast cancer should not take the pill, though a few participants in preliminary research incorrectly said they thought they could. The FDA review also flagged concerns that women with potential health problems will appropriately avoid taking the drug. But progestin-only pills have downsides, including reduced effectiveness if they’re not taken at the same time daily. Opill contains only progestin, making it a safer option and, according to experts, an easier regulatory switch to over-the-counter status. The addition of estrogen can help make periods lighter and more regular but it also carries the risk of rare blood clots. The most popular birth control pills today contain a combination of synthetic hormone progestin, which helps block pregnancy, plus estrogen. But the FDA called this figure “an imprecise estimate” because the study was significantly smaller than those typically used to evaluate contraceptive effectiveness. The company says its data show there would be about two pregnancies for every 100 women who take its pill for a year. The group included women of different ages, races, educational and cultural backgrounds. women taking its pill without professional supervision for up to six months. Perrigo’s main study tracked nearly 900 U.S. Forcing insurers to cover over-the-counter birth control would require a regulatory change by the Department of Health and Human Services. Non-prescription medicines are usually cheaper, but generally not covered by insurance. 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. Research for over-the-counter sales of the pill began nearly a decade ago. The company's application has no relation to the ongoing lawsuits over the abortion pill mifepristone, which is not a contraceptive. “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. women - or one-fifth of those who are child-bearing age - who currently use no birth control or less effective methods, such as condoms. Perrigo executives say Opill could be an important new option for the estimated 15 million U.S. The panel vote is not binding and the FDA is expected to make its final decision this summer. Friday'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.Īt the end of the meeting, the FDA panel will vote on whether the benefits of making the pill more widely available outweigh the potential risks.
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