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Application submitted to FDA for first-ever OTC birth control pill

Perrigo’s HRA Pharma has submitted an application to the US Food and Drug Administration (FDA) for possible future approval of the first-ever OTC birth control pill.

HRA Pharma, a Perrigo company, has announced it submitted an application to the US Food and Drug Administration (FDA) for possible future approval of the first-ever OTC birth control pill.1

This application is for an Rx-to-OTC switch for Opill (HRA Pharma), which is a progestin-only (or non-estrogen) daily birth control pill. Currently, Opill is approved by the FDA in 19731 to prevent pregnancy and has been an available progestin-only option for more than 50 years.

In a company press release announcing the submission, HRA Pharma said that removing the prescription hurdle to the pill would in turn improve access to a contraceptive “that is well tolerated and notably more effective at preventing pregnancy than all current methods available OTC.”

Further, the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians, have all voiced support for making birth control pills available OTC.

"As a doctor, I am dedicated to empowering people to make decisions about pregnancy prevention. 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," said obstetrician-gynecologist, Melissa J. Kottke, MD, MPH, MBA. "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."

An approval decision is expected sometime next year, according to the company.

Reference

1. Perrigo’s hra pharma submits application to fda for first-ever otc birth control pill. HRA_Pharma. Published 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