FDA Panel Votes Unanimously in Favor of First OTC Birth Control Medication

An FDA advisory committee voted unanimously today to recommend the approval of the first birth control pill to be made available OTC without a prescription.

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The FDA committee voted 17-0 to make the once-daily birth control medication Opill, manufactured by HRA Pharma under parent company Perrigo, available OTC. The vote followed a 2-day meeting that discussed whether the pill could be taken safely and effectively without supervision from a health care provider, according to a report by the Associated Press.¹

The FDA is expected to rule on the recommendation during the summer months. Committee members cited the benefits of making the Opill available OTC, including expanded access to effective birth control, fewer unintended pregnancies, and greater reproductive autonomy.

"I voted yes because the evidence demonstrates that the benefits clearly exceed the risks," Kathryn Curtis, a CDC health scientist with the division of reproductive health, told NPR.² "Opill has the potential to have a huge public health impact."

Opill is a non-estrogen medication with 0.075 g norgestrel, according to an HRA press release.³ It has been used to prevent pregnancy in millions of women in the United States since its FDA approval in 1973.

Progestin-only oral contraceptives block conception by inhibiting ovulation in approximately half of the cycles of users. The contraceptives thicken the cervical mucus to suppress sperm penetration, reducing the midcycle LH and FSH peaks, and slowing the movement of the ovum through the fallopian tubes.

With nearly 50 years of use and scientific evidence, Opill has been shown to be effective at preventing pregnancy and for most women to use.³

“This historic application marks a groundbreaking moment in contraceptive access and reproductive quality,” Frederique Welgryn, chief strategic operations and innovation officer at HRA Pharma, said in a press release after the company submitted the Opill application to the FDA in July 2022.³ “More than 60 years ago, prescription birth control pills in the US 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.”

Medical organizations such as the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians previously released statements in support of making birth control pills available OTC. Removing the prescription requirement would enable wider access to Opill, which is well tolerated and notably more efficient at preventing pregnancy than all currently available OTC methods, according to Perrigo.³

Prior to the unanimous vote, some FDA scientists expressed concerns regarding whether the pill could be effectively switched from prescription to OTC use, according to a report by NBC News.⁴

The scientists expressed doubts that the directions on the package's instruction label for correct use of the medication could be followed correctly after noting skepticism as to whether the manufacturer provided sufficient data. The FDA scientists said that the data submitted by the drug-maker was based on low quality studies, some of which were conducted in the 1960s and 1970s.⁴

The FDA scientists also pointed to findings from the Access study, which found that approximately 97% of the time, individuals reported taking the drug correctly or following the label’s instructions if a dose was missed. However, the FDA said “a substantial portion” of those in enrolled in the trial overestimated the amount of pills they took or took more pills than were dispensed.⁴

In a statement by Perrigo, the company noted that Opill has a long history of safe and effective use.

“Daily birth control was approved more than 60 years ago and progestin-only pills have a long track record as a safe and effective method to prevent pregnancy,” a Perrigo spokesperson told NBC News.⁵

Proponents of making Opill available OTC also pointed to the long history of safe and effective birth control use, adding that the benefits of OTC availability far outweigh the harms.

“We need to trust women,” Dr. Katalin Roth, a professor of medicine at the George Washington University of School of Medicine and Health Sciences, said after the vote, as reported by NBC News.⁵ “I urge the FDA to approve.”

References

1. Perrone M. FDA panel backs over-the-counter birth control pill. Associated Press. May 10, 2023. Accessed May 10, 2023. https://apnews.com/article/birth-control-pills-without-prescription-fda-d6e863b0d41a8c6c783c569773efa349

2. Hensley S; Stein R. Advisers to the FDA back first over-the-counter birth control pill. NPR. May 10, 2023. Accessed May 10, 2023. https://www.npr.org/sections/health-shots/2023/05/10/1175255611/advisers-to-the-fda-back-over-the-counter-birth-control-pill

3. Perrigo’s HRA Pharma Submits Application to FDA for First-Ever OTC Birth Control Pill. News release. HRA Pharma. July 11, 2022. Accessed May 10, 2023. https://www.hra-pharma.com/articles/perrigos-hra-pharma-submits-application-to-fda-for-first-ever-otc-birth-control-pill-66.

4. Lovelace, Jr B. FDA appears skeptical about over-the-counter birth control pill. NBC News. May 5, 2023. Accessed May 10, 2023. https://www.nbcnews.com/health/womens-health/otc-birth-control-fda-appears-skeptical-switching-prescription-only-rcna82858

5. Lovelace, Jr B. FDA advisory panels back making Opill birth control pill available over-the-counter. NBC News. May 10, 2023. Accessed May 10, 2023. https://www.nbcnews.com/health/health-news/opill-over-counter-birth-control-fda-advisory-committee-vote-rcna83506