The jury has spoken, giving a unanimous “yes” to push Perrigo’s birth control tablet Opill over the counter.
Wednesday, experts from a joint FDA meeting of outside experts voted 17 to 0 in favor of Opill’s over-the-counter approval pivot. If approved later this year by the FDA, Opill would become the first OTC daily hormonal birth control pill cleared in the U.S.
The unanimous vote came despite a number of big questions from the FDA about the potential for Opill’s responsible over-the-counter use in the real world. The FDA does not have to follow the advice of its advisory committees when making an approval vote, though it often does.
Panelists had one main question to consider. Namely: Was there “adequate information to conclude that consumers will be likely to use [Opill] properly, such that the benefits of making this available for nonprescription use … exceed the risks.”
Overall, panelists concluded that the benefits of an over-the-counter daily hormonal birth control pill outweighs the risks.
During the meeting, Karen Murry, M.D., deputy director of the FDA’s office of nonprescription drugs, said the FDA recognizes the importance of easier access to daily birth control for women. At the same time, the agency has been put “in a very difficult position” in determining whether Opill could be used safely and effectively over the counter.
The agency would have had a “much easier time” had Perrigo’s HRA Pharma “submitted a development program and an actual use study that was very easy to interpret and did not have so many challenges,” Murry said.
Many panelists, such as Deborah Armstrong, M.D., professor of oncology, gynecology and obstetrics at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, argued that the risks of unplanned pregnancy are much higher than those posed by Opill. Further, Armstrong argued that “the contraindication issues, I think, will be well understood.”
Ahead of the meeting, the FDA stressed that safety and effectiveness of Opill in a nonprescription setting is “contingent on whether a consumer can appropriately self-deselect and adhere closely to the directions for use, or correctly choose not to use the product.”
Still, the FDA’s expert panel concurred that the product is better suited to an over-the-counter nod than not.
“Safety was established 50 years ago when the original [Opill] approval was made,” said Kathryn Curtis, Ph.D. She argued that the “accumulating body of evidence since then has shown that these pills are safe with very few contraindications and long-term safety concerns.”
The regulatory race for over-the-counter Opill has garnered much attention in the wake of the U.S. Supreme Court’s decision last June to overturn the Roe v. Wade case that legalized abortion nationwide.
In support of its OTC approval, Perrigo has furnished the FDA with a label comprehension study designed to assess patients’ understanding of the OTC product’s label and breast cancer patients’ tendency to self-deselect from using the drug.
Perrigo also handed over results from a label comprehension study on its consumer information leaflet, which would accompany the drug facts label in Opill’s over-the-counter packaging.