FDA Schedules Advisory Committee Meeting for Nonprescription Birth Control

The FDA has scheduled a joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) on Nov. 18, 2022, to review the Perrigo’s application for Opill daily oral contraceptive for over-the-counter use.

Opill is a progestin-only daily birth control pill, which is also referred to as a mini pill or non-estrogen pill. While progestin-only birth control pills can still increase your risk of blood clots and stroke, they’re generally seen as safer for some women, including those who smoke, have high blood pressure or those at risk for blood clots.

HRA Pharma, a Perrigo company, had submitted its application in July 2022. “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,” Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma, said in a press release at the time. “Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”

Almost one-third of adult U.S. women who have ever tried to obtain prescription contraception reported access barriers, according to a 2016 survey. Women without insurance and those who spoke Spanish were significantly more likely to report difficulties. Barrier include costs, challenges obtaining an appointment or getting to a clinic, the clinician requiring a clinic visit, exam, or Pap smear, and not having a regular doctor/clinic.

Nonprescription birth control pills are available in many parts of the world, including Mexico. In July 2021, HRA received authorization from the Medicines and Healthcare Products Regulatory Agency for the OTC switch of Opill the United Kingdom.