Over-the-counter birth control pill faces FDA questions

WASHINGTON — U.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription.

But 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.

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. The agency also noted signs that study participants had trouble understanding the labeling instructions.

Advisers to the FDA meet next week to review drugmaker Perrigo’s application. The two-day public meeting is one of the last steps before a final FDA decision.

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.

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.

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 U.S. women — or one-fifth of those who are 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, 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 in the U.S., used by tens of millions of women since the 1960s.

Opill was first approved in the U.S. 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 U.S. but is sold without a prescription in the U.K.

FDA’s decision won’t apply to…