Application Submitted to FDA for First-Ever Over-the-Counter Birth Control Pill

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

This request is for a change from Rx to OTC for Opill (HRA Pharma), which is a progestin-only (or non-estrogen) daily contraceptive pill. Currently, Opill is FDA approved in 19731 to prevent pregnancy and has been a progestogen option available for over 50 years.

In a company press release announcing the submission, HRA Pharma said removing the pill prescription barrier would in turn improve access to a contraceptive that is “well tolerated and significantly more effective in preventing pregnancy.” than all current over-the-counter methods.

Additionally, the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians have all expressed support for making birth control pills available over the counter.

“As a doctor, I am dedicated to empowering people to make decisions about preventing pregnancy. For many, a birth control pill may be the best option for them, but requiring a prescription is an unnecessary barrier that can put it out of reach,” said obstetrician-gynecologist, Melissa J. Kottke, MD, MPH, MBA. “Removing the prescription requirement for a progestin-only contraceptive pill will be a historic advance in 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 FDA application for first-ever over-the-counter 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

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