Application to FDA for first-ever over-the-counter birth control pill

pharmafile | July 12, 2022 | News story | Manufacturing and Production  

The FDA is due to consider whether oral birth control medication should be made available to consumers over the counter, thus removing requirements to access such pills through a prescription, only. HRA Pharma submitted the first application for an over-the-counter pill to the FDA.

The company applied to the FDA for over-the-counter authorization of Opill®, a progestin-only daily birth control pill. The medication, known as a mini- or non-oestrogen pill, is currently approved as a prescription drug, and has been approved since 1973

Birth control pills require a prescription in the US. Whilst online birth control delivery services have made birth control pills more accessible, they still require a prescription, which may be difficult or expensive for some people.

Currently, the only birth control methods available in the US without a prescription are barrier methods, including condoms or birth control sponges.

Almost half of the over 6.1 million pregnancies in the US each year are unintended. Access to a range of methods for, and means of access to contraception, that meets people’s needs, will increase the likelihood of their use of effective birth control methods.

“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.,” said Frédérique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma. “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. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”

Following the Supreme Court’s overturn of Roe vs Wade revoking the federal right to abortion, the future of access to birth control has been under a spotlight. However, HRA Pharma’s chief strategic innovations officer told the New York Times that the timing of the application to the FDA was “a really sad coincidence”.

HRA Pharma officials have shared that they expect a decision from the FDA within 10 months.

Ana Ovey

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