The Food and Drug Administration on Friday posted its initial review of Opill, which could potentially become the United States’ first birth control pill to be sold over-the-counter rather than requiring a prescription.
Perrigo, French drugmaker HRA Pharma, applied to switch Opill from prescription-only to over-the-counter last July.
The FDA said in March that a panel would meet to discuss Perrigo’s request in May. That two-day meeting is scheduled for next week.
In Friday’s initial review, the FDA raised several questions about studies of OpIll, citing the reliability of some of the company’s data. The agency also raised questions about whether women with certain other medical conditions would correctly opt out of taking it. It further noted that some study participants had trouble understanding the instructions on the medication’s label.
The FDA planned to raise other questions at its upcoming meeting, as well, including whether younger teenagers would be able to understand and follow Opill’s instructions.
At the end of next week’s two-day meeting, the FDA panel will vote on whether to approve Opill over the counter, weighing whether the benefits of doing so would outweigh the risks. A final decision is expected this summer.
Perrigo executives say Opill could potentially benefit the estimated 15 million U.S. women—one-fifth of those of child-bearing age—who currently 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, Perrigo’s global vice president for women’s health, said earlier this week.
Hormone-based pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s.
Opill was first approved for use by prescription in the U.S. roughly 30 years ago.
Whatever the FDA decides, it won’t apply to any other birth control pills except Opill, though advocates hope that a decision to approve could push other drugmakers to seek over-the-counter sales.
