The U.S. Food and Drug Administration received its first application for an over-the-counter birth control pill. French drugmaker HRA Pharma announced Monday that it submitted an application to sell the pill in the U.S.
No other company has submitted an application to the FDA to move its birth control pill from prescription to over the counter. According to Time, HRA Pharma has been working on the application for seven years, while another company, Cadence Health, has also been working with the FDA for years to ready an over-the-counter birth control pill.
“We’re very proud of being the first company to submit the first-ever application to the FDA for daily birth control over the counter, and obviously it’s coming at the right moment,” said Frédérique Welgryn, innovation officer at HRA Pharma.
Time reported that the drug company did not plan for the news of the Supreme Court overturning Roe v. Wade and that even though it is the right time to announce, Welgryn emphasized “people need access to the full range of reproductive health care,” including abortion.
The New York Times reports that despite the timing of the submission, just weeks after the Supreme Court decision, HRA Pharma sees it as “a really sad coincidence,” according to Welgryn. “Birth control is not a solution for abortion access,” Welgryn said.
The National Library of Medicine found that nearly one-third of women have faced obstacles in accessing prescription birth control. The study found that most barriers included cost, lack of insurance, challenges obtaining an appointment, getting to a clinic, exams, not having a regular doctor and difficulties accessing a pharmacy.
The Washington Post reported that Susan F. Wood, former employee at the FDA, said she hoped the FDA would promptly approve the application and “doesn’t put any barriers” for its use, referring to age limits.
In 2006 the FDA approved the over-the-counter use of the emergency contraception pill, Plan B, also known as the “morning after pill,” but the medication didn’t become available without age limits until 2013 after major backlash over the age limits turned into legal battles.
Most applications for prescription drugs to become over-the-counter medications do not receive this sort of attention. However, HRA Pharm’s application is gaining recognition in the campaign for post Roe v. Wade decisions. After years in the application process, it is now gaining momentum and decisions should be made soon.
According to The New York Times, HRA Pharma officials expect an FDA decision will come back in 10 months. The FDA hasn’t commented on the application.