FDA Advisers Vote to Allow Perrigo's Opill Birth Control Pills to be Sold Over-the-Counter
Key Highlights :
The Food and Drug Administration (FDA) is one step closer to allowing the sale of Perrigo's Opill brand birth control pills over-the-counter in stores without a prescription. On Wednesday, a panel of federal advisers voted unanimously in favor of the drugmaker's request to make the progestin-only birth control pills available for purchase without a doctor's supervision.
This would be the first time oral contraception is available on store shelves in the United States without a prescription. If approved by the FDA, the Opill brand product could be rolled out as early as the end of this year. This move would address a key unmet need for contraceptive access and be a groundbreaking expansion for women's health nationwide.
The panel was asked to discuss and vote on whether the benefits of making norgestrel tablets available over-the-counter outweighed the risks of consumers taking them without a doctor's supervision. Ahead of the meeting, Perrigo told investors that it was expecting the FDA could decide on approval of over-the-counter Opill within the next three months.
The FDA had several concerns with Perrigo's request, including whether a key study might need to be re-run. In the study, which was designed to simulate over-the-counter use of Perrigo's drug, almost a third of participants reported taking far more tablets than they were supposed to receive. This raised doubts over the validity of the results from the study by Perrigo's contractor.
However, the FDA also acknowledged the stakes riding on their looming decision, especially as women face growing hurdles in trying to access contraceptives or abortion care. The panel members were skeptical that keeping norgestrel in a prescription-only status, for which it has already been long-approved, would be any better for patients.
Birth control pills are widely prescribed in the U.S., but most American patients take a newer "combined" version that includes an additional estrogen hormone. Only a small number who need to avoid estrogen take progestin-only pills, which the FDA says must be taken on a stricter regimen to be effective.
More than a hundred countries already allow sale of birth control pills without a prescription, a disparity the FDA acknowledges makes it harder for many Americans to access birth control. However, the FDA cautioned the panel that most of those countries had widened access to the pills within required guardrails unavailable to U.S. regulators. Pharmacists overseas still screen for issues that could make it unsafe or ineffective for patients to take it, like around potential drug interactions.
The FDA's decision on Perrigo's Opill brand birth control pills will be a major step forward in ensuring people can have improved access to contraception without unnecessary barriers. If approved, the product could be available in stores later this year and could be a groundbreaking expansion for women's health nationwide.
