FDA advisers endorse over-the-counter birth control pill

A panel of outside advisers to the Food and Drug Administration (FDA) unanimously voted Wednesday that the benefits of making a birth control pill available over the counter outweigh the potential risks.

The 17-0 vote represents a major step forward in the decades-long push to make birth control pills available without a prescription for the first time ever.

The FDA is expected to make a final decision later this summer. The agency does not have to follow the panel’s recommendation, but it often does.

Members of the agency’s advisory board said the risks of unintended pregnancy were far greater than any risks associated with the drug, called Opill.

Making it available over the counter would significantly expand access to contraception, especially for younger women and those in rural and underserved communities, who currently need to overcome logistical barriers to get their birth control.

Hormone-based birth control has required a prescription, usually so providers can screen for risk of rare blood clots. But over-the-counter (OTC) birth control is available in more than 100 countries worldwide.

Opill, manufactured by HRA Pharma, was first approved for use with a prescription 50 years ago. Opill is a progestin-only pill, rather than a combination pill of progestin and estrogen, so it has virtually no risk of clotting. But it can be less effective if it’s not taken around the same time every day.

But FDA scientists raised a number of red flags over the course of the two-day meeting,  especially regarding the quality of the company’s data about whether people would understand and follow the instructions and take the pill at the same time every day.

Agency scientists were also concerned about whether women with medical conditions that should preclude them from taking the pill will know to avoid it without talking to a physician first.

The agency was also concerned about whether adolescents and people with limited literacy would be able to understand the instructions.

Yet the panel members largely disagreed, and said they felt the consequences about a lack of access to contraception outweighed the agency’s concerns.

“I think in the balance between benefit and risk, we have a hard time justifying not taking this action. The benefits are large, the drug is incredibly effective. I think it will be effective in the over the counter realm just as it is in the prescription realm,” said Maria Coyle, the chairwoman of the committee and an associate clinical professor at The Ohio State University College of Pharmacy, who voted yes.

“Do I think we got perfect data? No. Do I think it was a perfect study? No. Do I think it was adequate to feel reassured that a large number of people can use this drug as intended? Yes,” said Cynthia Baur, a health literacy researcher at the University of Maryland who voted in favor of OTC access.

A year after the Supreme Court overturned Roe v. Wade and ended the constitutional right to an abortion, reproductive health has been under political and legal attack. Contraception hasn’t garnered as much pushback, but advocates note threats to access are a constant fear.

A Texas federal judge in December ruled that federal clinics that confidentially distribute contraception to teens violate Texas state law and U.S. constitutional rights.

And Justice Clarence Thomas argued that the Supreme Court “should reconsider” its past rulings codifying the right to contraception access.

Many of the leading anti-abortion groups haven’t taken a stance, but major Catholic groups, including the U.S. Conference of Catholic Bishops, are arguing against over-the-counter access to contraceptives. They argue that teens and young adults should need parental and provider permission, because it will lead to an increase in sexually active young people.

Advocates called on the FDA not to be persuaded by the politics and opposition and to ensure Opill is available for reproductive age women of all ages, without restrictions.

“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.,” said Victoria Nichols, project director of Free the Pill.

Updated at 2:38 p.m.

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