FDA panel votes in favor of the first over-the-counter birth control pill

In a highly significant move, a panel of independent experts on Wednesday voted unanimously that the Food and Drug Administration should approve the first over-the-counter birth control bill, a recommendation that holds the potential to transform the way contraception is delivered in the United States.

After nearly two days of deliberations, the FDA advisory panel weighed a gamut of data and analyses to assess whether the pill — which was first approved as a prescription medicine decades ago — would be safe, effective and, importantly, easy for women of all ages to use appropriately. It voted 17-to-0 in favor of making the pill accessible over the counter; the FDA is expected to make a final decision this summer.

The meeting was held amid growing support for an over-the-counter birth control pill to lower a high rate of unintended pregnancies. Perrigo, which manufactures the pill, has estimated that 15 million women in the U.S. — or 20% of those who are of child-bearing age — currently do not use birth control or rely on less effective methods, such as condoms.


“The risks to women of unintended pregnancies are much greater than any other risks we discussed about putting this pill out there over-the-counter,” said Katalin Roth, a professor at the George Washington University School of Medicine. “To the extent that approving this pill will go a long way toward rectifying (the health care system) is a very important move.”

The pill, called Opill, contains only progestin, which makes it a safer option compared with combination pills that contain both progestin and estrogen. Women with more medical conditions would be precluded from taking combination pills. But progestin-only pills have downsides, including reduced effectiveness if they’re not taken at the same time daily.


The first day of the meeting included extensive discussion of the barriers many women face to access birth control. Panelists and members of the public in attendence noted women in low income, rural and marginalized communities lack insurance or face logistical hurdles — such as transportation or time off work — to obtain a prescription medicine.

For these reasons, many medical organizations — including the American Medical Association American College of Obstetricians and Gynecologists, and the Society for Adolescent Health and Medicine — have supported making birth control pills available over the counter. The pill is not currently available in the U.S, but oral contraceptives are available in Europe and Latin America.

Advocacy groups quickly hailed the panel vote.

“Decades of coalition-driven advocacy and research efforts that have centered the voices of those most impacted by barriers to contraception caused by systemic inequities have made this possible. It is past time for an over-the- counter birth control pill, which has the potential to advance reproductive justice and expand health equity,” said Victoria Nichols of Free the Pill, an advocacy group, in a statement.

More than three-quarters of women of child-bearing age favor making birth control pills available over the counter without a prescription if research showed they are safe and effective, according to a poll conducted last year by the Kaiser Family Foundation. And 39% reported they would likely use an over-the-counter birth control pill that does not require a prescription if it is approved by the FDA.

Despite the unanimous vote and relatively few reservations subsequently expressed by the panelists, an FDA approval is not a given.

A key issue before the panel was whether women who take the pill — especially younger adolescents or those with limited literacy — may have difficulty understanding instructions on the label. The pill would have to be taken at the same time every day. If a dose is missed, women would be instructed avoid sex or temporarily use other birth control.

The panel, FDA staff, and representatives from the manufacturer, Perrigo, also tackled questions about whether women with certain medical conditions, such as breast cancer or vaginal bleeding, would be aware they should avoid taking the pill.

There was also debate about study data. FDA medical staff raised questions about the reliability of the data after noting about 30% of study participants reported they erroneously took more pills than were actually supplied. FDA officials suggest this outcome – called overreporting, or improbable dosing – suggested that some women incorrectly used the pill or incorrectly reported their use.

“The FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively at the nonprescription setting,” said Karen Murry, deputy director of the FDA Office of Non-Prescription Drugs, during the second day of session, which was held on Wednesday.

“We can’t just approve it based on the experience in the prescription setting without the applicant doing adequate studies to look at what’s likely to happen in the nonprescription setting. But I wanted to again emphasize that (the) FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for U.S. women,” she added.

Although FDA staffers said the manufacturer likely used research methods that exaggerated positive results, the study data appeared to assuage the panel. For instance, 97% of breast cancer patients correctly chose not to take the pill and study participants had taken the pill on 93% of the days when they were supposed to have done so. And nearly 85% of the participants had taken the pill on at least 85 of the days.

Nearly half of U.S. pregnancies are unintended, a significantly higher rate than in many other wealthy countries, according to the Guttmacher Institute, a policy group that supports abortion rights. Many of the speakers during the public session at the meeting argued such incidents rates reflect difficulties some women have gaining easy access to health care.

“It can be days in an ideal situation, but more often its weeks and months” before a woman can see a doctor, said Kristyn Brandi, a health equities fellow at the American College of Obstetricians & Gynecologists. “And for someone that is waiting for contraception at that visit, that can be too long. It would be so much better for people to be able to pick it up right then and there when they need it.”

“In this moment, when a third of our country is facing unprecedented barriers to access reproductive health and abortion care, we need to remove every medically unnecessary hurdle to effective contraception,” said Daniel Grossman, a professor of obstetrics and gynecology, and reproductive sciences at the University of California, San Francisco, who has studied birth control and abortion pills.

Source: STAT