Health regulators in the United States are considering the first request to make a birth control pill available without a prescription.
Food and Drug Administration (FDA) advisers will meet next week to review drugmaker Perrigo’s request to sell a decades-old pill without a prescription. The two-day public meeting is one of the last steps before the FDA makes a decision.
If the FDA grants the company’s request, Opill will be the first birth control pill available over the counter, either over the counter or online.
In an initial review published Friday, the FDA raised several concerns about Opill’s studies, citing issues with the reliability of some of the company’s data and raising questions about whether it is used by women with certain other medical conditions.
The agency will ask the panel to consider whether the younger women will be able to understand and follow the instructions.
At the end of the meeting, the FDA panel will vote on whether the benefits outweigh the potential risks. The panel’s vote is not binding and the FDA is expected to make its final decision in the middle of this year.
Perrigo executives say Opill could be an important new option for the nearly 15 million American women, or one-fifth of those of reproductive age, who are currently not using birth control or less effective methods, such as female condoms.
Opill was first approved in the United States about 30 years ago. Perrigo acquired the rights to the drug last year with its purchase of Paris-based HRA Pharma.
The FDA’s decision will not apply to other birth control pills, only Opill, although supporters of the move hope its approval could encourage other pill makers to get OTC approval. Birth control pills are available without a prescription in much of South America, Asia, and Africa.
