FDA advisers vote unanimously in favor of OTC birth control pills

A panel of independent medical experts for the Food and Drug Administration voted unanimously on Wednesday in favor of allowing the hormonal birth control pill Opill (norgestrel) to be sold over the counter rather than by prescription.

The 17-0 vote by the panel came after a two-day meeting in which the experts reviewed data and analyses from the pill's maker, Laboratoire HRA Pharma, and FDA scientists, as well as heard public comments on the potential switch.

Opill is a once-a-day pill containing only progestin. It was first approved in 1973 and has shown to be remarkably safe in the five decades since then, proving safer than combination hormone pills that have risks of blood clots. Experts estimate Opill is about 93 percent effective at preventing pregnancy in real-life use, higher than the real-life efficacy of other easily accessible birth-control methods, such as condoms (around 87 percent).

If the FDA chooses to follow the advisers' recommendation and make the pill OTC, it would be the first time that a hormonal birth control pill would be accessible without a prescription or other barriers. The move comes at a time when women's health care and reproductive autonomy are under intense attack, with most abortions now banned in 14 states and other restrictions either in place or brewing in many others.

The panel of experts followed their unanimous vote with strong statements to the FDA that Opill's switch to OTC would be safe, effective at preventing unwanted pregnancies, and would significantly improve reproductive autonomy and equity in the country.

"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," panel member Katalin Roth, a medical professor at George Washington University, said in closing remarks. "The history of women's contraception is a struggle for women's control over their reproduction, and we need to trust women."

In addition to considering the safety and efficacy data presented and discussed at the meeting, Roth and several other panelists pointed to the moving arguments made in the public comment section yesterday, the vast majority of which supported the switch to OTC.

The commenters included college sophomore Rebecca Heimbrock, who provided a personal example of the struggles for access to birth control in rural, low-resource settings. Heimbrock grew up in rural Appalachia and was denied birth control pills that could help her manage pain from endometriosis. "As a teenager I was told by my doctor that I shouldn't start the birth control pill because it would make me more likely to become sexually active," she said. "Of course we know that this is not true, and young people without access to birth control simply have sex without being on birth control."

Strong consensus

There was much discussion in the meeting about whether teens would be able to navigate use of the pill without guidance from a doctor, particularly since the pill's efficacy is tied to consistent use every day in the same three-hour window. But, several experts on the panel who care for adolescents were not particularly worried about this--adherence is a problem across the board, and a short conversation with a doctor who might only see a woman once a year isn't going to be remarkably different than reading instructions on a box, they argued. Overall, the easier access to the pill clearly outweighed the risks, they said.

Elise Berlan, a clinical pediatrics professor at Ohio State University and a faculty doctor in the adolescent medicine division at Nationwide Children's Hospital, championed access for teens. "The barriers in access to contraceptives are real and very harmful--and amplified in adolescence," she said in remarks explaining her vote. Those barriers perpetuate health inequities in communities, such as poor birth outcomes, and morbidity and mortality from pregnancy, she added. "The health risks of pregnancy--which is the condition that these products aim to prevent--is much greater than the use of any contraceptive product, and this is among the safest of the contraceptive products."

"I also wanted to emphatically state that I do believe that adolescents will make good decisions about their reproductive health," Berlan concluded. "We can trust teens to make these decisions."

Although the FDA scientists had expressed concern about the reliability of the data on patient adherence to the once-a-day schedule, several panel members urged the regulator not to delay OTC availability while collecting more data.

"I think this represents a landmark in our history of women's health," said Margery Gass, a retired professor of obstetrics and gynecology at the University of Cincinnati. "Unwanted pregnancies can really derail a woman's life and especially an adolescent's life, so I'm very pleased that the FDA is seriously considering this, and I look forward to it being on the market."

The panel's support for OTC birth control aligns with major health organizations. The American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians have all previously endorsed OTC availability of oral birth control.