FDA to Review Application for First-Ever OTC Birth Control Pill

The non-estrogen pill was first approved by the FDA in 1973.

HRA Pharma has submitted an application to the FDA for the first-ever OTC birth control pill in the United States. The company is asking for an Rx-to-OTC switch for Opill, its progestin-only birth control pill.1

If approved, this would be the first daily birth control pill available OTC without a prescription in the United States.1

Opill is a non-estrogen pill with 0.075 g norgestrel, according to a press release. It has been used to prevent pregnancy in millions of women in the United States since its FDA approval in 1973. With nearly 50 years of use and scientific evidence, the pill has been shown to be effective at preventing pregnancy and for most women to use.1

“This historic application marks a groundbreaking moment in contraceptive access and reproductive quality,” said Frederique Welgryn, chief strategic operations and innovation officer at HRA Pharma, in the press release. “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.”1

Medical organizations such as the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians have expressed support for 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 the press release.1

“As a doctor, I am dedicated to empowering people to make decisions about pregnancy prevention,” Melissa J. Kottke, MD, MPH, MBA, an obstetrician-gynecologist, said in the press release. “For many, a birth control pill may be the best option for them, but requiring a prescription is an unnecessary obstacle that can put it out of reach.”1

The application comes after the US Supreme Court decision in June to overturn Roe v. Wade, the case that legalized abortion nationwide in 1973. Following this decision, some legislators have indicated that they could restrict access to contraception in some states, in particular intrauterine devices (IUDs).

Despite these suggestions from some legislators, legal experts say the future of these discussions is unclear because the Supreme Court decision is vague regarding at what point in a pregnancy abortion could be permitted.

“Basically, this ruling has allowed states to ban abortion but kind of has left the door open, because they were ambiguous…So, this could potentially bleed over into contraception,” Ron Lanton III, Esq, partner at Lanton Law, said in an interview with Pharmacy Times.

HRA Pharma expects the FDA to make a decision in the first half of 2023, according to reporting by Reuters. A period of about 10 months is typical for Rx-to-OTC applications.2

“Removing the prescription requirement for a progestin-only birth control pill will be a historic advancement for pregnancy prevention and a remarkable achievement in community public health,” Kottke concluded in the press release.1

REFERENCES

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

2. Leo L. FDA to review first ever over-the-counter birth control pill. Reuters. July 11, 2022. Accessed July 11, 2022. https://www.reuters.com/business/healthcare-pharmaceuticals/perrigo-unit-submits-approval-application-fda-otc-birth-control-pill-2022-07-11/