The first birth control pill available without a prescription in the US has a chance of becoming a reality. 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 a “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. Getting a prescription 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 or other devices and medications that require a 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.
Opill was first approved by the FDA in 1973. 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 a New York Times report. The FDA didn’t immediately respond to a request for comment.
Read more: Could a Post Roe v. Wade World Impact Your Access to Birth Control?
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.
