• Posted May 9, 2023

FDA Experts to Consider First Over-the-Counter Birth Control Pill

As a U.S. Food Drug Administration advisory panel prepares to weigh whether to recommend that a birth control pill be sold over the counter in this country, a coalition of advocates on Monday called attention to the safety and effectiveness of the medication.

If approved, Opill, a daily progestin-only birth control pill, would become the first such drug sold over the counter in the United States. Opill was first approved by the FDA in 1973. During a media briefing on the coming decision, the Free the Pill coalition said it hopes this pill will be fully covered by insurance and available to people of all ages and backgrounds without a prescription.

Meanwhile, the FDA's expert panel will hold a two-day meeting, starting on Tuesday, to decide whether to recommend allowing the Opill to be sold without a prescription.

There is no precise information available on how much Opill will cost if sold over the counter, but Opill manufacturer Perrigo said in a recent statement that it is committed to making it affordable.

The American Medical Association, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists (ACOG), and other medical organizations support over-the-counter access to hormonal contraception without age restrictions.

The Free the Pill coalition has been advocating for over-the-counter status for birth control pills since 2004, citing the many barriers that exist for people who want to use birth control pills, especially those from marginalized communities.

"For many, these barriers include the cost and time associated with a health care visit to get a prescription, transportation to that visit, finding childcare during the appointment for parents, and parental consent for young people," said Victoria Nichols, project director of Free the Pill, during the briefing.

The FDA isn't obligated to follow the guidance of its advisory panels, but it typically does.

Exactly how the panel will vote on Wednesday is unknown, but there have been some signals to suggest members may be skeptical.

In briefing documents filed before the meeting, FDA officials raised concerns about whether people will use these pills appropriately. The label suggests that pills must be taken at the same time every day, and there isn't enough information about what could happen if someone misses this window. There's also a risk of breast cancer and undiagnosed vaginal bleeding with this pill, and some concern that people won't be able to evaluate these safety risks for themselves. All of these issues will be up for discussion during the two-day panel hearing,

Opill was first up for review in November 2022, but the FDA delayed a decision to review additional information. The FDA is expected to decide on Opill by the end of the summer, and this decision won't apply to other birth control pills.

Dr. Kristyn Brandi believes Opill should be sold over the counter. She is ACOG's Darney-Landy Fellow and an obstetrician/gynecologist in Newark, N.J.

"I trust my patients to read the label, read the box and take the medication they need,"she said during the briefing.

The risks are incredibly low, Brandi said. Side effects may include breast tenderness, acne, headache or bloating, among others.

The one major contraindication for this pill is having active breast cancer.

But "the vast majority of people with active breast cancer are already seeing several health care providers who will have the conversation with them about birth control,"Brandi added.

The FDA also cited concerns that the pill may not be as effective in people who are overweight or obese. Brandi does not think that this will or should be an issue. "We don't do anything different for patients that are obese who take the pill [via prescription],"she said.

Making a birth control pill available without a prescription is even more important in the wake of the U.S. Supreme Court ruling overturning Roe v. Wade last June, a decision which eliminated the constitutional right to terminate pregnancies, kicking the issue back to the states.

"People are already facing barriers to the reproductive health care that they need and deserve,"Brandi noted. "Over-the-counter access to contraception is not a solution to abortion bans, but increasing access to contraception will help more folks be able to prevent pregnancy"¦ and the value of this can't be overstated."

More information

The American College of Obstetricians and Gynecologists offers more on choosing the best birth control method.

SOURCES: May 8, 2023, media briefing with: Victoria Nichols, project director, Free the Pill, Cambridge, Mass.; Kristyn Brandi, MD, Darney-Landy Fellow, American College of Obstetricians and Gynecologists, obstetrician/gynecologist, Newark, N.J.