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AG Nessel Urges FDA to Approve Country’s First OTC Birth Control Pill
November 07, 2022
LANSING — Michigan Attorney General Dana Nessel joined a multistate coalition of 21 attorneys general, led by California, in submitting a letter urging the U.S. Food and Drug Administration (FDA) to approve over-the-counter birth control bills that meet applicable safety and efficacy standards, including a pending application for the nation’s first over-the-counter (OTC) pill. If approved, safe and effective birth control pills will become available for purchase over the counter, removing barriers that currently keep many people from being able to access safe and timely reproductive care. In the letter, the attorneys general argue that approval of the pill would allow individuals — especially those from vulnerable populations — greater control over their health, lives, and futures, and help them avoid the health and economic perils that come with unwanted pregnancies.
"This over-the-counter pill provides an important advancement in access to birth control for millions of women, especially Michigan women who, since the Dobbs decision overturning Roe v. Wade, remain in a holding pattern with regard to their bodily autonomy," Nessel said. "Easier access to birth control is valuable for women's health and self-determination and I am proud to join my colleagues in asking the FDA to approve HRA Pharma's pending application to make an over-the-counter birth control pill."
The FDA is currently reviewing an application to approve a birth control pill, named Opill, for OTC use. If approved, people in need of birth control would be able to walk into a pharmacy and buy it without a prescription, making it the first-ever birth control pill that people can buy OTC.
In the open letter to the FDA, the attorneys general assert that the pill should be approved for OTC use because:
- It has been found to be safe and effective for most users. Studies show that progestin-only pills, like Opill, carry a much lower risk of blood clots than traditional-combination estrogen and progestin birth control pills because they contain synthetic progestin and no estrogen. And studies of progestin-only birth control pills show that they are over 90% effective in preventing unintended pregnancies — more effective than methods such as spermicide, condoms, or the sponge.
- It would remove barriers faced by many in obtaining birth control. Researchers say one-third of adults in the U.S. who have ever tried to obtain prescription contraception have reported facing challenges, such as in getting an appointment, having to travel for clinic visits, or navigating restrictions on the amount they can buy monthly. Further, one-third of birth control users say they have missed taking their birth control because they could not get their next supply in time. An OTC birth control pill would remove many of these challenges and make it less likely for people to be forced to go through unintended pregnancies due to circumstances outside their control.
- It would provide critical help to people from vulnerable populations. Barriers to accessing birth control disproportionately impact people of color, low-income families, and individuals living in rural areas, who are more often underinsured or uninsured, and thus find it harder to get the reproductive care they need. OTC options would go a long way in reducing these inequities and making the healthcare system fair and accessible for all. The benefits of such a system include lower maternal mortality rates, less poverty, higher levels of physical and mental health, and more economic freedom and opportunity for vulnerable communities.
In the letter, the Attorneys General point out that approving an OTC birth control pill is supported by the medical community. Three major medical organizations in the United States — The American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians — support making birth control available without prescription. Moreover, birth control pills are already available over the counter in approximately 100 countries, including Mexico.
The Attorneys General also assert that in the wake of the U.S. Supreme Court’s decision overturning Roe v. Wade earlier this year, many states have banned or restricted abortion care, narrowing the choices for those seeking reproductive care and making access to birth control even more critical nationwide, including for residents of Michigan who may be traveling, living, working, or studying in anti -abortion states.
In filing the open letter, AG Nessel joins the attorneys general of California, Colorado, Connecticut, Hawaii, Illinois, Iowa, Maine, Maryland, Massachusetts, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington.
A copy of the letter is available here.