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Attorney General Josh Stein Urges FDA to Approve Country’s First OTC Birth Control Pill

For Immediate Release:
Friday, November 4, 2022

Contact: Nazneen Ahmed

 If approved, the pill would be available to buy without a prescription, removing barriers to accessing safe and timely reproductive care

(RALEIGH) Attorney General Josh Stein today urged the U.S. Food and Drug Administration (FDA) to approve over-the-counter birth control pills 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.

“Women’s reproductive freedom is extremely important to their ability to live the kind of lives they want,” said Attorney General Josh Stein. “I will continue to do everything in my power to ensure that women have access to the life-changing reproductive health care they need.”

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. 
  • It would remove barriers to obtaining birth control many users face. 
  • It would provide critical help to people from vulnerable populations. 

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.

In filing the open letter, Attorney General Stein joins the attorneys general of California, Colorado, Connecticut, Hawaii, Illinois, Iowa, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington.

A copy of the letter is available here.