First Application for OTC Birth Control Pills Submitted to FDA

HRA Pharma announced on July 11, 2022 that the company submitted the first application for an over-the-counter (OTC) birth control pill in the United States to the Food and Drug Administration (FDA). [1]

The application asks that Opill, a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill), be switched from prescription-only to OTC. The drug is already sold OTC in England under the brand name Hana. [1] [2]

Frédérique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma, stated: “This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S. More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.” [1]

While the timing of the application, just weeks after the US Supreme Court overturned federal abortion protections, was coincidental, the political climate around reproductive healthcare is likely to continue to influence the debate over whether birth control pills should be available OTC. The FDA is still experiencing blowback from loosening restrictions on medication abortions. [2] [3] [4]

The debate over age-restrictions is especially anticipated given the same debate surrounded the FDA’s approval to move Plan B (an emergency contraceptive) to OTC in 2006. The drug was not approved to be sold OTC without age restrictions until 2013. Kristi Hamrick, spokesperson for Students for Life, said of birth control pills: “it’s common sense not to recklessly sell these pills.… [T]aking adults out of the equation is a problem.” [2] [3]

Birth control pills are available OTC in much of the world. OTC access is supported by many US medical organizations, including the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians. [2] [4]

HRA Pharma, based in Paris, France, stated it expected a response from the FDA in about 10 months, the usual timeline for such applications. [2]

Discussion Questions

1. Should birth control pills be available over-the-counter? Why or why not?

2. If birth control pills were available OTC, should age or other restrictions be implemented? Explain your answer(s).

3. Should other reproductive healthcare medications be available over-the-counter or by mail? Consider Plan B, abortion medication, and others. Explain your answer(s).

Sources

1. Perrigo Company plc, “Perrigo’s HRA Pharma Submits Application to FDA for First-Ever OTC Birth Control Pill,” prnewswire.com, July 11, 2022

2. Sheryl Gay Stolberg and Kate Kelly, “F.D.A. to Weigh Over-the-Counter Sale of Contraceptive Pills,” nytimes.com, July 11, 2022

3. Reuters, “Perrigo Unit Asks FDA to Approve First Ever OTC Birth Control Pill,” reuters.com, July 11, 2022

4. Matthew Perrone and the Associated Press, “Pharma Company Asks to Be the First to Sell Its Birth Control Over the Counter,” fortune.com, July 11, 2022