FDA weighing 1st over-the-counter birth control pill

WASHINGTON (AP):

United States (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 granted 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 yesterday, 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 labelling 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 currently use no birth control or less effective methods, such as condoms.

“We have no doubt that our data clearly show 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 US, used by tens of millions of women since the 1960s.