FDA weighing over-the-counter pill
Would be a first for birth control
The FDA’s decision won’t apply to other birth control pills, only Opill, which was first approved 50 years ago.
WASHINGTON—US health regulators are weighing the first-ever request to make a birth control pill available without a prescription.
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. The two-day public meeting is one of the last steps before an FDA decision.
If the FDA 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.
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.
At 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. The panel vote is not binding and the FDA is expected to make its final decision this summer.
Perrigo executives say Opill could be an important new option for the estimated 15 million US women — or one-fifth of those who are child-bearing age — who use no birth control or less effective methods, such as condoms.
“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.
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.
Hormone-based pills, like Opill, have long been the most common form of birth control, used by tens of millions of women since the 1960s.
Opill was first approved in the United States 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 United States but is sold without a prescription in the United Kingdom.
FDA’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. Birth control pills are available without a prescription across much of South America, Asia, and Africa.
Many common medications have made the over-the-counter switch, including drugs for pain relief, heartburn, and allergies. Generally, drug makers must show that consumers can accurately understand and follow the labeling instructions to safely and effectively use the drug. Non-prescription medicines are usually cheaper, but generally not covered by insurance. Forcing insurers to cover over-the-counter birth control would require a regulatory change by the Department of Health and Human Services.
Perrigo’s main study tracked nearly 900 US women taking its pill without professional supervision for up to six months. The group included women of different ages, races, educational, and cultural backgrounds.
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.
But after Perrigo wrapped up its study, the FDA identified a problem: nearly 30 percent of women erroneously reported taking more pills than they were actually supplied.
The FDA said Friday these cases of “improbable dosing” call into question the company's results.
Perrigo will present a reanalysis of the data that excludes the participants who overreported. The company says the results showed the study still achieved its goal of demonstrating that most women used the pill correctly.
Women reported taking the pill on a daily basis 92 percent of the time during the study, the company says.
The company says its data show there would be about two pregnancies for e ver y 100 women who take its pill for a year. But the FDA called this figure “an imprecise estimate” because the study was significantly smaller than those typically used to evaluate contraceptive effectiveness.