A birth control pill available for 50 years can now be used without a prescription, making it the first over-the-counter oral contraceptive approved by the FDA. The regulatory decision makes contraception more accessible to more people, offering the potential to reduce the incidence of unintended pregnancies.

The product, Opill, is made by HRA Pharma, a subsidiary of Perrigo. Dublin-based Perrigo said Thursday it plans to make the non-prescription version of this drug available in stores and online in the first quarter of next year. The company said pricing and distribution plans will be provided in the coming months in advance of the product launch.

Opill’s main ingredient is norgestrel, a synthetic version of the hormone progestogen. This drug and others like it work by suppressing ovulation. Opill has been used safely for years, but the product’s label warns it should not be used by those who have ever had breast cancer or any cancer that is sensitive to progestin, which is synthetic progestogen. The FDA also said Opill should not be used together with other hormonal birth control products, nor should it be used for emergency contraception.

“Overall, I expect that the availability of nonprescription norgestrel tablet will result in a substantial increase in use of effective contraception among people who wish to avoid unintended pregnancy,” Karen Murry, deputy director of the FDA’s office of nonprescription drugs, wrote in the FDA decision document. “I expect this to be particularly true among people who currently experience significant barriers to obtaining contraception, for example people who live in poverty, those who cannot take off from work or school to attend physician appointments, and adolescents.”

In order to switch a prescription drug to non-prescription status, the FDA requires a company to demonstrate consumers can use the product safely and effectively based only on the nonprescription drug labeling and without the help of a clinician. Generating that evidence does not require another clinical trial. Typically, companies conduct a label comprehension study to assess whether the drug facts label effectively communicates safe and effective use of the product.

HRA’s Opill application was based on a label comprehension study and a targeted breast cancer self-selection study, in which those with breast cancer or a past case of breast cancer must correctly choose not to use the product. The FDA said that while three people with a history of progestin-sensitive cancers chose incorrectly, overall consumer comprehension of the drug’s label was good in both studies.

HRA also conducted an actual use study of Opill. In this study, which required participants to report how many pills they took, the results were more problematic. The FDA noted 30% of participants reported taking more tablets than were dispensed, which calls into question all of the study data. The FDA concluded the issue was likely due to design flaws in the electronic diary used to capture data. In the future, the FDA said it will ask drug companies to design these diaries in ways that reduce the likelihood of inaccurate reporting.

The FDA advisory committee that discussed the Opill application in May was not overly concerned about the data challenges in the drug’s consumer studies. Committee members said there is a public health need to increase access to effective contraception, consumers are likely to take the tablet daily as the drug’s label instructs, and the drug is safe. The committee voted unanimously that the benefits of making Opill an OTC product outweigh the risks.

Public support for OTC oral contraception is strong. A Kaiser Family Foundation survey last fall found that 77% of respondents want birth control pills to be available without a prescription. The change also has support in the medical community. The American College of Obstetricians and Gynecologists (ACOG) has long backed OTC access to hormonal contraception.

“Barriers to access are one reason for inconsistent use or lack of use of contraception,” ACOG interim CEO Christopher Zahn said in a statement issued after the FDA decision. “Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers, such as taking time off work for an appointment, paying an office visit copay, or navigating sometimes-confusing prescription refill protocols. This change will allow for more patients to easily begin and continue using birth control consistently.”

Opill was originally a product of Pfizer, which marketed the pill under the brand name Ovrette. In 2005, the drug giant discontinued the product for business reasons, according to documents HRA submitted to the FDA as part of the product’s review. HRA acquired the drug’s rights in 2015 and began discussions with the agency about the data needed to support an application to switch the drug to OTC use.

Opill is an old drug but it’s a relatively new product for Perrigo. The company acquired HRA last year in a €1.8 billion (about $2.1 billion) deal that bolstered its OTC offerings. Soon after that deal closed, the new Perrigo subsidiary submitted an application seeking to change the drug from prescription to over-the-counter status. Women’s health, a new financial reporting category encompassing products from both Perrigo and HRA, accounted for $45.2 million in sales last year, according to Perrigo’s 2022 annual report.

Photo: Getty Images, Sarah Silbiger