The FDA has approved the first over-the-counter oral contraceptive, making it more accessible and potentially reducing unintended pregnancies. The product, Opill, manufactured by HRA Pharma, will be available without a prescription in stores and online next year. Opill contains norgestrel, a synthetic hormone that suppresses ovulation. Despite being used safely for years, the drug should not be taken by those who have had breast cancer or cancer sensitive to progestin. The FDA decision aims to make effective contraception more accessible to those who face barriers to obtaining it, such as poverty, work or school commitments, and adolescents.
To switch a prescription drug to non-prescription status, the FDA requires evidence that consumers can use the product safely and effectively based solely on the nonprescription drug labeling. HRA’s application for Opill was backed by a label comprehension study and a breast cancer self-selection study, which showed good consumer understanding of the drug’s label. However, an actual-use study revealed that 30% of participants reported taking more tablets than were dispensed, which was attributed to design flaws in the electronic diary used to capture data.
Despite the data challenges, the FDA advisory committee voted unanimously in favor of making Opill available over the counter due to the public health need for increased access to effective contraception and the perception that consumers are likely to follow the drug’s instructions. Public support for OTC oral contraception is strong, with 77% of respondents in a Kaiser Family Foundation survey favoring non-prescription availability.
The American College of Obstetricians and Gynecologists (ACOG) also supports OTC access to hormonal contraception, acknowledging that barriers to access contribute to inconsistent or lack of use. ACOG believes that making birth control pills easily accessible at pharmacies or drug stores will eliminate some barriers, such as time off work for appointments, copays, and confusing prescription refill protocols.
Opill, originally marketed as Ovrette by Pfizer, was discontinued in 2005 for business reasons. HRA Pharma acquired the drug’s rights in 2015 and began discussions with the FDA to switch it to OTC use. Perrigo acquired HRA last year in a €1.8 billion deal, expanding its OTC offerings. Women’s health products, including Opill, accounted for $45.2 million in sales for Perrigo and HRA last year.
Overall, the FDA’s decision to approve the over-the-counter use of Opill marks a significant milestone in contraception access. It offers the potential to increase the use of effective contraception, particularly among those facing barriers to obtaining it. The approval aligns with the desires of the public and medical community and may contribute to the reduction of unintended pregnancies in the future.
