Drugmaker seeks FDA approval of over-the-counter birth control pill : Shots - Health News Birth control pills are available in the U.S. only with a prescription. Now a drugmaker is asking the FDA to approve a progestin-only contraceptive that would be available without one at pharmacies.

Over-the-counter birth control pills are available worldwide. The U.S. may be next

Drugmaker HRA Pharma has asked the Food and Drug Administration to approve an over-the-counter birth control pill called Opill. The agency's review process is estimated to take about 10 months. Peter Dazeley/Getty Images hide caption

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Peter Dazeley/Getty Images

Drugmaker HRA Pharma has asked the Food and Drug Administration to approve an over-the-counter birth control pill called Opill. The agency's review process is estimated to take about 10 months.

Peter Dazeley/Getty Images

A pharmaceutical company based in Paris, HRA Pharma, is seeking approval from the U.S. Food and Drug Administration for an over-the-counter birth control pill. The pill includes progestin only, not estrogen, and is known as a mini pill. If approved, it would be the first oral contraceptive available in the U.S. without a prescription.

"This could be a really groundbreaking change in access," says Victoria Nichols of Free the Pill, a coalition of advocates, researchers and health care providers that has helped lay the groundwork and build support for regulatory approval of over-the-counter pill options in the United States.

The coalition's work began more than a decade ago, but the application for approval — submitted in the wake of the overturning of Roe v. Wade — comes at a time of renewed attention to the importance of contraception access. "I think there's absolutely greater urgency today to have better contraceptive access across the United States," says Cynthia Harper, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco.

Nearly 30% of women of childbearing age report a problem obtaining a birth control prescription or refills, according to survey research published in 2016. The reasons include lack of insurance, not having a regular doctor or challenges making an appointment. "There absolutely are barriers to contraception and access for people in this country," says Dr. Jennifer Villavicencio, who heads equity transformation at the American College of Obstetricians and Gynecologists (ACOG), which has about 60,000 members. She points to logistical obstacles — or hassles — to seeing a doctor and filling prescriptions as well. "Taking time off work, getting child care, driving, parking, all of those things," she says.

ACOG has supported access to over-the-counter hormonal contraceptives since 2012. The American Medical Association has also signaled its support. "The science and data has shown for a while that birth control is very safe to offer over the counter and doesn't need a prescription," Villavicencio says.

She points to other countries, including Mexico and many others in Latin America and Europe, that have opened up access to oral contraceptives by allowing the pills to be sold over the counter at pharmacies without a prescription. "The lessons learned from other countries who have had over-the-counter birth control have shown us that it works," Villavicencio says. In 2021, HRA Pharma received a license to bring a nonprescription contraceptive pill to the United Kingdom too.

HRA Pharma's daily birth control pill is called Opill. Because it does not contain the hormone estrogen, it carries a lower risk of blood clots, which is a risk factor that medical providers screen for when prescribing birth control pills.

This lower-risk profile may make it easier to win over-the-counter approval. "The progesterone-only pill as the first over-the-counter pill in the United States would make a lot of sense," says Dr. Melissa Simon, a professor of clinical gynecology at Northwestern University.

The progesterone-only pill has a little bit less room for error than the combined pill, which has both estrogen and progesterone in it. "What that means is you don't have as much room to miss a pill or to even mistime your pill," says Villavicencio. And because of that, the efficacy with typical use goes down to about 91%, according to the U.K.'s National Health Service. "That is still very effective," says Villavicencio.

HRA Pharma must meet a bunch of criteria to win over-the-counter approval in the United States. For instance, it must provide evidence that individuals would be able to screen themselves to determine whether the pill was right for them. The company must also show that people could take the daily contraceptive pill as intended without a doctor's explanation. "That's something the pharmaceutical company has to prove through their data and research," says Free the Pill's Nichols. She explains that the coalition has helped build evidence over the last decade, which she says is strong. "We believe that these pills are safe and effective and that people should be able to follow the simple instructions," says Nichols.

In March, a group of lawmakers, including the co-chairs of the Pro-Choice Caucus in the House of Representatives, sent a letter to FDA Commissioner Robert Califf urging the agency to review applications for over-the-counter birth control pills without delay. The lawmakers pointed to systemic inequities in the health care system that create barriers to access. "These barriers are disproportionately borne by people of color, immigrants, LGBTQ+ people, low-income individuals, young people, and people in rural communities — individuals who have faced and continue to face the greatest inequities," the letter stated. The lawmakers said the FDA has an important role to play in reducing barriers to help provide people greater control over their reproductive health.

The FDA review process is expected to take about 10 months, with a decision expected in 2023.