USA — The U.S. Food and Drug Administration (FDA) is considering whether to allow the first-ever over-the-counter contraceptive pill.
Perrigo, the drug manufacturer, has submitted an application to sell its birth control pill, Opill, without a prescription.
Recently, the Food and Drug Administration (FDA) released a preliminary review expressing numerous concerns about Perrigo’s application to sell its contraceptive pill, Opill, over the counter.
The FDA cited problems with the reliability of some of the company’s data, including participants’ difficulty in understanding the labeling instructions and questioned whether women with certain medical conditions would be able to correctly opt out of taking it.
Perrigo executives argue that Opill could be a crucial option for the estimated 15 million U.S. women who currently use no birth control or less effective methods, such as condoms.
The company’s application has no relation to the ongoing lawsuits over the abortion pill mifepristone, which is not a contraceptive. Research for over-the-counter sales of the pill began nearly a decade ago.
However, the FDA’s review suggests serious reservations about broad access to the drug, including whether younger teenagers would be able to correctly follow the labeling directions.
The FDA’s panel of advisers will meet next week to review Perrigo’s application in a two-day public meeting.
The panel will vote on whether the benefits of making Opill more widely available outweigh the potential risks. While the panel vote is not binding, the FDA is expected to make its final decision this summer.
Hormone-based pills, like Opill, have been the most common form of birth control in the U.S. since the 1960s.
Opill was first approved in the U.S. 50 years ago and was acquired by Perrigo last year with its buyout of Paris-based HRA Pharma, which bought the pill from Pfizer in 2014.
Opill is not currently marketed in the U.S. but is sold without a prescription in the U.K.
FDA’s decision will only apply to Opill, not to other birth control pills. However, advocates hope that an approval decision might push other pill makers to seek over-the-counter sales.
While many common medications have made the over-the-counter switch, including drugs for pain relief, heartburn, and allergies, drugmakers must show that consumers can accurately understand and follow the labeling instructions to safely and effectively use the drug.
Perrigo’s main study tracked nearly 900 U.S. women taking its pill without professional supervision for up to six months.
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, which is key to the drug’s ability to block pregnancy.
However, after the study, the FDA identified nearly 30% of women erroneously reported taking more pills than they were actually supplied.
The FDA flagged concerns that women with potential health problems may take the drug inappropriately.
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.
Additionally, women who have unusual vaginal bleeding are instructed to talk to a doctor first, because it could indicate a medical problem.
But the FDA notes that half of women in Perrigo’s study who had unexplained bleeding incorrectly said Opill would be appropriate for them.
Opill contains only progestin, making it a safer option and, according to experts, an easier regulatory switch to over-the-counter status.
However, progestin-only pills have downsides, including reduced effectiveness if they’re not taken at the same time daily.
Opill’s data show that there would be about two pregnancies for every 100 women who take its pill for a year.
However, the FDA called this figure “an imprecise estimate” because the study was significantly smaller than those typically used to evaluate contraceptive effectiveness.
Several major U.S. medical groups, including the American Medical Association, support making the drugs available over the counter.
However, Catholic groups, including the United States Conference of Catholic Bishops, are opposing Opill’s application, stating that women should be evaluated by a doctor before getting it.
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