FDA Advisers OK Approval of First Over-the-Counter Birth Control Pill

WEDNESDAY, May 10, 2023 (HealthDay News) -- In a unanimous vote, a panel of expert advisers to the U.S. Food and Drug Administration on Wednesday endorsed the over-the-counter (OTC) sale of a birth control pill, a recommendation that will likely pave the way for far greater access to contraception for Americans.

Opill was first approved by the FDA in 1973. There is no precise information available on how much Opill will cost if sold OTC, but Opill manufacturer Perrigo said recently that it is committed to making the medication affordable.

"Today's vote to recommend a switch of Opill to OTC is a new, groundbreaking chapter in reproductive health. Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.," Perrigo President and CEO Murray Kessler said in a company news release. "We are motivated by the millions of people who need easy access to safe and effective contraception."

The American Medical Association, American Academy of Family Physicians, American College of Obstetricians and Gynecologists, and other medical organizations already support OTC access to hormonal contraception without age restrictions.

And the FDA panel agreed. "I do believe this is a viable option to support access and will support the prevention of unintended and unwanted pregnancies," said panel member Jolie Haun, Ph.D., a researcher with the U.S. Department of Veterans Affairs, who voted in favor of the pill, the Associated Press reported.

However, FDA officials have voiced some misgivings about OTC access to birth control pills, including concerns about whether people will use these pills appropriately. But those fears did not sway the advisory panel.

"The panel expresses confidence in the effectiveness, not only in the general population of females, but also in adolescent populations and those with limited literacy," said panel chairwoman Maria Coyle, a pharmacist and an associate clinical professor at Ohio State University, the AP reported. "The panel seems very comfortable with the limited number of risks from the medication itself."

With a full decision expected this summer, the FDA is not obligated to follow the guidance of its advisory panels, but it typically does.

Associated Press Article