A panel of Food and Drug Administration advisors voted unanimously on Wednesday that the benefits of making an over-the-counter birth control pill outweigh the risks, a significant step in the decades-long effort to make oral contraception available over the counter in the United States.
If the FDA approves over-the-counter sales of the drug, called Opill, this summer, it could significantly expand access to contraception, especially for young women and those who struggle with the time, cost or logistical hurdles involved in visiting a medical, reproductive health Experts say.
The approval is not a foregone conclusion, however. FDA scientists who analyzed data submitted by the pill’s manufacturer, HRA Pharma, raised concerns about whether women with medical conditions that prevent them from taking the pill — particularly breast cancer and undiagnosed vaginal bleeding — would avoid the product.
Agency reviewers also questioned the reliability of data from a company study that purported to show that consumers would follow label instructions to take the pill at approximately the same time each day and use another form of contraception or abstain from sex if that would happen. miss a dose. FDA reviewers also raised questions about whether younger teens and people with limited literacy could follow the instructions.
“The FDA has been put in a very difficult position of trying to determine whether women are likely to safely and effectively use this product in the over-the-counter environment,” said Dr. Karen Murry, deputy director of the FDA’s Office of Over-the-Counter Drugs, during the advisory panel discussion session on Wednesday afternoon.
“We can’t just approve it based on experience in the prescribing environment without the applicant doing adequate studies to see what is likely to happen in the nonprescribing environment,” she said. “But I wanted to emphasize again that the FDA realizes how important women’s health is and how important it is to try to increase access to effective contraception for US women.”
Advisory committee members said those concerns were largely outweighed by the need for public health and the long history of safety and efficacy of Opill, which was approved for prescription use 50 years ago.
“The panel expresses confidence in efficacy not only in the general female population, but also in the adolescent population and those with limited literacy,” said Maria Coyle, committee chair, pharmacist and associate clinical professor at Ohio State University. “The panel seems very comfortable with the limited number of risks of the drug itself.”
Advisory committee members included a wide range of medical professionals: obstetricians-gynecologists, specialists in adolescent medicine, a breast cancer specialist, and specialists in consumer health behavior and health literacy.
The FDA had originally scheduled the committee’s public hearing for last November, but postponed it until this spring after asking the company to submit additional information.
Since the Supreme Court overturned the national right to abortion nearly a year ago, access to contraception has become more urgent. The initiative to make an over-the-counter pill available for all ages has gained support from reproductive and adolescent health experts and groups such as the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians.
In a survey conducted by the health research organization KFF, more than three-quarters of women of reproductive age favored an over-the-counter pill, primarily because of convenience.
While some Catholic organizations have spoken out against over-the-counter birth control, most anti-abortion groups have remained silent on the issue. Support was expressed in the vast majority of the hundreds of comments submitted ahead of the hearing, which began on Tuesday, and by the majority of the 37 people who spoke during the public comment section of the hearing.
Opill is known as a “mini-pill” because it contains only one hormone, progestogen, in contrast to “combination” pills, which contain both progestogen and estrogen. A company that makes a combination pill, Cadence Health, is also in discussions with the FDA about applying for over-the-counter status.
doctor Daniel Grossman, professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, spoke in support of the over-the-counter effort at Tuesday’s advisory committee hearing. He said in an interview that both types of pills were safe and about 93% effective in preventing pregnancy with normal use.
Combination pills have been more popular in the United States, but that may be because progestin-only pills, which are widely used in Europe, are not widely marketed there, he said.
HRA Pharma, which was bought last year by Perrigo, a Dublin-based over-the-counter pharmaceuticals maker, already sells an over-the-counter progestin-only pill in the UK.
