FDA Advisors OK Approval of First Over-the-Counter Birth Control Pill

WEDNESDAY, May 10, 2023 (HealthDay News) -- In a unanimous vote, a panel of expert advisors to the U.S. Food and Drug Administration on Wednesday endorsed the over-the-counter sale of a birth control pill, a recommendation that will likely pave the way for far greater access to contraception for Americans.

Opill, as the pill is called, was first approved by the FDA in 1973. There is no precise information available on how much Opill will cost if sold over the counter (OTC), but Opill manufacturer Perrigo said recently that it is committed to making the medication affordable.

"Today’s vote to recommend a switch of Opill to OTC is a new, groundbreaking chapter in reproductive health. Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.,” Perrigo President and CEO Murray Kessler said in a company news release. “We are motivated by the millions of people who need easy access to safe and effective contraception."

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

And the FDA panel agreed.

“I do believe this is a viable option to support access and will support the prevention of unintended and unwanted pregnancies,” said panel member Jolie Haun, a researcher with the U.S. Department of Veterans Affairs, who voted in favor of the pill, the Associated Press reported.

Meanwhile, 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.

On Wednesday, the group applauded the panel's decision.

“Today, in a historic step forward for reproductive health, a joint FDA advisory committee voted in favor of moving a progestin-only birth control pill over the counter," said Victoria Nichols, project director of Free the Pill. "It is past time for an over-the-counter birth control pill, which has the potential to advance reproductive justice and expand health equity. Now, we look to the FDA to follow the committee’s recommendation, in addition to the overwhelming data, and approve the first-ever over-the-counter birth control pill in the U.S."

With a full decision expected this summer, the FDA isn’t obligated to follow the guidance of its advisory panels, but it typically does. However, FDA officials have voiced some misgivings about over-the-counter access to birth control pills.

In briefing documents filed before the meeting, the agency 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.

But those fears did not sway the advisory panel.

“The panel expresses confidence in the effectiveness, not only in the general population of females, but also in adolescent populations and those with limited literacy,” said panel chairwoman Maria Coyle, a pharmacist and an associate clinical professor at Ohio State University, the AP reported. “The panel seems very comfortable with the limited number of risks from the medication itself.”

Opill was first up for over-the-counter 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, ACOG’s Darney-Landy Fellow and an obstetrician/gynecologist in Newark, N.J., believes Opill should be sold over the counter.

“I trust my patients to read the label, read the box and take the medication they need,” she said during a Monday media briefing held by the Free the Pill coalition.

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, but 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.; Associated Press; The New York Times