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The FDA considers first birth control pill without a prescription

Advisers to the Food and Drug Administration will make a recommendation about whether the agency should approve the first over-the-counter birth control pill in the U.S.
Sarah Silbiger
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Getty Images
Advisers to the Food and Drug Administration will make a recommendation about whether the agency should approve the first over-the-counter birth control pill in the U.S.

For the first time, the Food and Drug Administration is considering allowing women to get birth control pills in the U.S. without a prescription.

"It's a very exciting historic moment for contraceptive access," says Kelly Blanchard, who heads Ibis Reproductive Health, a nonprofit research group.

On Tuesday, the agency is convening a two-day meeting of independent advisers to help it decide what to do. The FDA advisers will sift through the scientific evidence and make a recommendation to the agency, which is expected to make a final decision by the end of the summer.

Eliminating prescriptions would ease access

Birth control pills have a long track record. But in the U.S. women have always had to get a prescription first to get them, which can make it hard for many women, Blanchard says.

"It could be someone doesn't have a health care provider," Blanchard says. "It could be the time it would take to get an appointment, the cost to get to that appointment, taking time off work, organizing child care. All of those things really add up."

Allowing women of any age to just walk into their any drug store to buy pills off the shelf could make a huge difference, especially for less affluent women, she says.

The request is for a pill that would be sold by Perrigo under the brand name Opill, a so-called progestin-only pill that only contains a synthetic version of the hormone progesterone to prevent pregnancy. Most pills also contain estrogen.

Major medical groups, such as the American Medical Association and the American College of Obstetricians and Gynecologists, are backing the request.

Drugmaker Perrigo is seeking Food and Drug Administration approval to sell the oral contraceptive Opill without a prescription.
/ Perrigo
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Perrigo
Drugmaker Perrigo is seeking Food and Drug Administration approval to sell the oral contraceptive Opill without a prescription.

But groups like the Catholic Medical Association are opposed, and not just on religious grounds.

In addition to questioning the safety of making a birth control available without a prescription, that group argues that easier access would help sex traffickers and that skipping the requirement to see a doctor would harm women's health in other ways.

"It eliminates the need to see a physician for young ladies to see a physician for the prescription," says Dr. Timothy Millea, who head's the association's health care policy committee. "That will eliminate the screenings for ovarian cancer, for cervical cancer, for sexually transmitted infections."

The FDA asks questions

An FDA assessment also raised questions about taking a health professional out the equation. FDA scientists questioned whether women would take the pill every day at the same time, as they're supposed to, and whether women who shouldn't take the pill because of certain health problems would know that.

But proponents dismiss those concerns, arguing there's plenty of evidence that women can easily handle it. Pills are available without a prescription in more than 100 other countries.

"We think the evidence is quite clear," says Dr. Jack Resneck Jr., the AMA's president. "First of all, oral contraceptives have been used safely by millions of women in the United States and around the world since the 1960s."

Moreover, while regular exams are important, "they're not necessary prior to initiating or refiling an oral contraceptive," Resneck says.

Resneck and others add that easy access to effective birth control has never been more important, given that access to abortion is increasingly being restricted in this country.

"Reproductive rights are under attack," says Dr. Daniel Grossman, who studies reproductive health issues at the University of California, San Francisco. "Certainly in places where abortion access have become more restricted, it's critical that people have access to all the the possible tools to prevent an unwanted pregnancy."

Editing by Scott Hensley

Copyright 2023 NPR. To see more, visit https://www.npr.org.

Rob Stein is a correspondent and senior editor on NPR's science desk.