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HRA Pharma Seeks FDA Approval For First OTC Birth Control Pills

If approved, Opill would be the first daily birth control pill available OTC without a prescription in the US.

Photo by Gabriela Sanda from Pixabay.

KUALA LUMPUR, July 12 – HRA Pharma has submitted its application to the United States’ Food and Drug Administration (FDA) for the first over-the counter (OTC) birth control pills in the US. 

The company has applied for an Rx (doctor’s prescription) for Opill, a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill).

If approved, Opill would be the first daily birth control pill available OTC without a prescription in the US. 

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

“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 birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”

Out of the more than 6.1 million pregnancies in the US each year, nearly half are unintended.

Major medical organisations such as the American College of Obstetricians and Gynaecologists, the American Medical Association, and the American Academy of Family Physicians have voiced their support for making birth control pills available OTC.

Approved by the FDA in 1973, Opill has been used to prevent pregnancy in millions of women in the US.

Almost 50 years of scientific evidence and use have shown that progestin-only pills like Opill are effective in preventing pregnancy, and are safe for most women to use. 

As a daily use contraceptive, Opill is to be used pre-conception, for it to be effective in preventing pregnancy. 

In the US, almost a third of adult women who have ever tried to obtain a prescription or refill for contraceptives, whether pill, patch, or ring, have reported difficulties doing so.

If the prescription requirement is removed for Opill, it would improve access to a contraceptive method that is well tolerated and more effective at preventing pregnancy than all current methods available OTC, according to Perrigo Company, a pharmaceutical and self-care product company that owns HRA Pharma, in its press release.

“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-gynaecologist Melissa J. Kottke. 

“Removing the prescription requirement for progestin-only birth control pills will be a historic advancement for pregnancy prevention and a remarkable achievement in community public health.”

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