FDA advisers have recommended the availability of OTC birth control pill, pending a final decision. Switching prescription drugs to OTC status is rare, and birth control pills are a significant example.
Perrigo, the pharmaceutical company that applied for OTC approval of the pill, expects the FDA to make its final decision later this year.
OTC Birth Control Pill: A Possible Solution to Unintended Pregnancies in the US
- Around three million unintended pregnancies occur annually in the US
- Up to one-third of women face obstacles in getting a prescription for the pill or other reversible contraception
The FDA will be evaluating the switch to OTC availability for birth control pills at a time when the approval of the abortion pill mifepristone is being legally contested, and reproductive rights are the focus of national debates. Following the vote, members of the advisory committee expressed significant concern about ensuring that women could obtain contraception. The public’s comments during the two-day meeting heightened their apprehension about the issue.
Abbey Berenson, the director of the Center for Interdisciplinary Research in Women’s Health, as well as an obstetrics, gynecology & pediatrics professor at the University of Texas (Galveston), stated, “Access is an incredibly important issue to women, especially now. The switch to OTC will improve access and allow women to use more effective methods”.
The members of the panel expressed confidence in the pill’s safety and effectiveness, based on its long history of use. They opined that consumers could be entrusted to use the pill without a doctor’s guidance.
Katalin Roth, a professor at George Washington University, stated that the risks associated with unintended pregnancies are much higher than any potential risks associated with making the pill available over the counter. Roth emphasized that the history of women’s contraception has been a struggle for control over their reproductive health and that women should be trusted.
All 17 members of the panel supported OTC access to the pill, although there were concerns about adolescents using it. One panel member suggested that the pill be kept behind the counter at pharmacies to address concerns about young women using it without medical supervision.
However, some panel members, including pediatric specialists, advocated for no age limits. Elise Berlan of the Nationwide Children’s Hospital highlighted that adolescents face significant access barriers and that teens can be trusted to make their own decisions regarding contraception.
Leslie Walker-Harding, who is the chief academic officer and senior vice president of the Seattle Children’s Hospital, stated that among all potential contraceptive users, adolescents have the lowest risk. She mentioned that people of all ages can use this medication in a safe and effective manner.
While the FDA reviewers expressed concern about whether women who should not use the pill would avoid it if it were available over the counter, such as those with breast cancer or who have survived it, the panel members pointed out that the benefits of OTC use outweighed the risks. They also noted that breast cancer patients usually consult with their doctors who can advise them on contraception.
In briefing documents ahead of the panel hearing, the FDA had expressed concern about women who may be discouraged from seeking medical care if the pill were available OTC. The agency also highlighted concerns about whether OTC access to the pill could reduce the use of condoms, which can help prevent sexually transmitted infections (STIs).
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