- A Food and Drug Administration advisory committee on Wednesday unanimously supported approval of the first over-the-counter birth control pill, saying better access was urgently needed for women of child-bearing age.
- The recommendation comes more than 60 years after the FDA cleared the first oral contraceptive, revolutionizing women’s health. Known simply as “the pill,” versions of the drug have been used all over the world by more than 300 million women.
- Perrigo is now vying to change the prescription-only status of the drug. The company’s version, sold as Opill, was approved by the FDA in 1973. The 17-0 FDA panel vote is a “groundbreaking chapter in reproductive health,” Perrigo said. While the agency isn’t required to accept the advice of its expert committees, it usually does.
Switches from prescription to OTC use are relatively rare, and few are as potentially consequential as birth-control pills. About 3 million unintended pregnancies occur each year in the U.S., and Perrigo cited research showing as many as a third of women who have tried to obtain a prescription for the pill or other reversible birth control have had difficulties doing so.
The FDA will be considering the change amid legal challenges to its approval 23 years ago of the abortion pill mifepristone and a national debate over reproductive rights. In their comments after the vote, advisory committee members said they were extremely concerned about making sure women could obtain contraception, especially after hearing from the public during the two-day meeting.
“Access is an incredibly important issue to women, especially now,” said Abbey Berenson, a professor of obstetrics, gynecology and pediatrics and director of the Center for Interdisciplinary Research in Women’s Health at the University of Texas in Galveston. The switch to OTC “will improve access and allow women to use more effective methods” of birth control, she said.
Panel members said they were reassured by the long history of safe and effective use of the pill and believed consumers could be trusted to use it without the guidance of a doctor.
“The risks to women of an unintended pregnancy are much greater than any of the things we were discussing as risks of putting this pill out over the counter,” said Katalin Roth, a professor at George Washington University’s medical school in Washington, D.C. “The history of women’s contraception is a struggle for women’s control over their reproduction and we need to trust women.”
While all 17 panel members were united in their support for OTC access to the pill, there was some concern when it came to younger adolescents. One panel member suggested behind-the-counter use at a pharmacy could be an option to deal with concerns about young women using the pill without a medical professional. Still others — including pediatric specialists — said there should be no limits by age.
“Barriers and access to contraceptives are real and very harmful and amplified in adolescence,” said Elise Berlan of the Nationwide Children’s Hospital in Columbus, Ohio. “We can trust teens to make these decisions.”
Adolescents also have the lowest risk of any potential patient using contraceptives, said Leslie Walker-Harding, chief academic officer and senior vice president of the Seattle Children’s Hospital. “This safe and effective medication can be used by all ages,” she said.
In briefing documents ahead of the panel hearing, FDA reviewers also raised concerns about whether women who shouldn’t use the pill — such as those with breast cancer or who have survived it — would avoid it if available in the local pharmacy. Panel members said they felt the benefits of OTC use outweighed these risks and noted that breast cancer patients are generally already very engaged with doctors who could also advise them on contraception.
Perrigo expects the FDA to make its final decision on approval of over-the-counter use of Opill later this year.