The FDA could approve the first over-the-counter birth control pill
Birth control pills require a prescription in the US, but that could change soon. HRA Pharma has filed an application with the U.S. Food and Drug Administration to sell its “mini-pill” over-the-counter, according to a Monday Notice by HRA Pharma parent company Perrigo.
The specific drug in use is Opill, a progestin-only pill or mini-pill approved since 1973.
More than 65% of women aged 15 to 49 use some form of birth control, including 14% who choose the birth control pill. by data from 2017 to 2019 by the US Centers for Disease Control and Prevention. Oral contraceptives, another term for birth control pills, are highly effective in preventing pregnancy. They are also used to treat some diseases, including endometriosis.
While American College of Gynecologists and Obstetricians and the American Academy of Family Physicians have supported access to over-the-counter birth control pills to reduce unplanned pregnancies and other health outcomes.have made it easier for some to get birth control pills, they still require a prescription. Actually getting the drug prescribed can be difficult or expensive for some people and medical communities
The only birth control methods available in the US without a prescription are barrier methods, including condoms or contraceptive sponges. While condoms have the benefit of protecting against sexually transmitted infections, barrier methods are generally less effective than birth control pills, IUDs, and other methods that require a doctor’s visit or prescription.
Mostincluding Plan B, Take Action, and other brands that contain levonorgestrel do not require a prescription and are available over the counter.
That abortion rights last month. But the timing of HRA Pharma’s application to the FDA for the first over-the-counter pill was a “really sad coincidence,” said Frédérique Welgryn, the company’s chief strategic and innovation officer, said The New York Times.has been part of the conversation for the past few weeks, particularly since the US Supreme Court revoked federal
Mini pills like Opill only contain progestin instead of the more common ones combination pills who have estrogen and progestin. However, because they work slightly differently than combination pills, minipills need to be taken within one of each day tighter time window to be effective. However, since they do not contain estrogen, mini pills are safe or cannot tolerate estrogen for any reason.
HRA Pharma officials expect a decision from the FDA within 10 months, according to the Times. The FDA did not respond to comment.
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 healthcare provider with any questions about a medical condition or health goals.