Birth control over the counter? This might be the reality in the United States if a French pharmaceutical gets it way
Birth control over the counter? This might be the reality in the United States if a French pharmaceutical company gets its way.
In an unprecedented move, French drugmaker, HRA Pharma, has asked permission from the U.S. Food and Drug Administration (FDA) to sell a birth control pill over the counter in the United States.
The company has applied for an Rx-to-OTC switch for its brand-named pill Opill, a progestin-only daily birth control pill. (The pill is also referred to as a mini pill or non-estrogen pill.) If approved, this would be the first daily birth control pill available over the counter without a prescription in the United States.
The move comes as legal and political battles over women’s reproductive rights remain strong since the U.S. Supreme Court overturned Roe v. Wade in June. The company says the timing was unrelated to the ruling, according to the Associated Press (AP).
“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.,” Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma, said. “More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”
According to the New England Journal of Medicine, almost half of the more than 6.1 million pregnancies in the United States in 2011 were unintended. HRA Pharma says access to a range of methods and ways to access contraception that meet people’s needs will increase the likelihood of using effective birth control methods.
Since the 1960s, hormone-based pills have been the most popular form of birth control used by women in the United States. But they have always required a prescription. Why? Primarily because contraceptives’ like this have been related to venous thromboembolisms—blood clots that can lead to very serious or fatal complications.
There are two types of hormonal contraceptives: one that contains only progestin (like the proposed Opill), and another that combines progestin and estrogen. According to the Cleveland Clinic, hormonal birth control that contains estrogen is the type linked to blood clots.
Major medical organizations, including the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians, have expressed support for moving birth control pills to over the counter receipt.
But the American Heart Association (AHA) warns of the risks of taking birth control pills, even the ones that are progestin-only. Although the AHA says progesterone-only birth control is safe for women with congenital heart disease in most cases, it can still lead to fluid retention in the body.
Additionally, smokers should be careful. A combination of birth control pills and smoking can be very dangerous to women and is not recommended by the AHA. Especially in younger women, the combination of birth control pills and smoking increases the risk of heart disease by a whopping 20 percent, according to AHA.
An FDA decision can come as early as the first half of 2023. It would only apply to HRA’s pill. In order for a drug to move from prescription to over the counter, manufacturers must prove the medications’ safety. Generally, they must be clearly labeled, have low potential for misuse and abuse and other important factors.
Many women’s health advocates support HRA’s efforts to make the pill OTC, including Ibis Reproductive Health, an organization that supports abortion and contraceptive access.
“Today we’re celebrating the first-ever application for an OTC birth control pill being submitted to the FDA by HRA Pharm. This is a key milestone in the movement-driven effort to advance #ReproJustice and contraceptive equity across the US,” the organization Tweeted on Monday.
Ibis and other partners conducted research and built consensus on the need for an OTC birth control for a decade. In 2016, the organization partnered with HRA Pharma to conduct the research needed to submit an Rx-to-OTC switch application to the FDA.
Victoria Nichols is a project director of Free the Pill, a project of Ibis’ that works to bring birth control pills over the counter in the United States.
“Research has documented that the prescription requirement is a barrier for many people and can push birth control out of reach because it means a potentially costly health care provider’s visit, taking time off school or work to get to the appointment, and more,” Nichols said.
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