FDA weighing 1st OTC birth control pill

Agency questioning drugmaker’s study results already.

U.S. health WASHINGTON — 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 this week to review drug- maker 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.

In an initial review posted Friday, the FDA raised several concerns about studies of Opill, citing problems with the reliability of some of the company’s data and raising questions about whether women with certain other medical conditions would correctly opt out of taking it. It also noted signs that study participants had trou- ble 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 poten- tial 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-thecounter setting,” Frederique Welgr yn, 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.

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.

Perrigo’s m ain study tracked nearly 900 U.S. 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% 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.