FDA weighing 1st over-the-counter birth control pill
U.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription
WASHINGTON (AP) — U.S. 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.
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 trouble understanding the labeling instructions.
