FDA Might Authorize First Over-the-Counter Birth Control Pill

Birth control pills require a prescription in the US, but that might be on track to change. HRA Pharma has submitted an application to the US Food and Drug Administration for over-the-counter sales of its "mini pill," according to a Monday announcement from HRA Pharma parent Perrigo.

The specific medication in the application is Opill, a progestin-only pill, or mini pill, that's been approved since 1973.

More than 65% of women ages 15 to 49 use some form of birth control, including 14% who choose birth control pills, according to data from 2017 to 2019 from the US Centers for Disease Control and Prevention. Oral contraceptives, another term for birth control pills, are highly effective at preventing pregnancy. They're also used to manage some medical conditions including endometriosis.

While online birth control delivery services have made it easier to get birth control pills for some, they still require a prescription. Actually getting prescribed the medication may be difficult or expensive for some people, and medical societies including the American College of Gynecologists and Obstetricians and the American Academy of Family Physicians have supported access to birth control pills over the counter as a way to reduce unplanned pregnancies and other health outcomes.

The only birth control methods available without a prescription in the US are barrier methods, including condoms or birth control sponges. While condoms have the benefit of protecting against sexually transmitted infections, barrier methods in general are usually less effective than birth control pills, IUDs and other methods that require a doctor's visit or prescription. 

Most emergency contraception pills, including Plan B, Take Action and other brands that contain levonorgestrel, don't require a prescription and are available over the counter. 

The future of birth control access has been part of the conversation in recent weeks, especially since the US Supreme Court overturned Roe v. Wade last month, revoking the federal right to abortion. But the timing of HRA Pharma's application to the FDA for the first pill available without prescription was a "a really sad coincidence," Frédérique Welgryn, the company's chief strategic and innovations officer, told The New York Times.

Mini pills like Opill contain just progestin, instead of the more-common combination pills that have estrogen and progestin. Because they work slightly differently than combination pills, however, mini pills need to be taken each day within a narrower window of time in order to be effective. But because they don't contain estrogen, mini pills are safe for someone who's breastfeeding or can't tolerate estrogen for any reason.  

HRA Pharma officials expect a decision from the FDA within 10 months, according to the Times. The FDA didn't respond for comment.