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Drugmaker seeks FDA approval for over-the-counter birth control pill: Shots

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Drugmaker HRA Pharma has applied to the Food and Drug Administration for approval of an over-the-counter birth control pill called Opill. The agency’s review process is expected to take approximately 10 months.

Peter Dazeley/Getty Images


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Peter Dazeley/Getty Images


Drugmaker HRA Pharma has applied to the Food and Drug Administration for approval of an over-the-counter birth control pill called Opill. The agency’s review process is expected to take approximately 10 months.

Peter Dazeley/Getty Images

A Paris-based pharmaceutical company, HRA Pharma, is ask for approval from the United States Food and Drug Administration for an over-the-counter birth control pill. The pill contains only progestin, no estrogen, and is known as the mini-pill. If approved, it would be the first oral contraceptive available in the United States without a prescription.

“This could be a truly game-changing change in access,” says Victoria Nichols of release the pilla coalition of advocates, researchers, and healthcare providers that helped lay the groundwork and build support for regulatory approval of over-the-counter pill options in the United States.

The work of the coalition began more than a decade ago, but the request for approval — made following the overthrow of the Roe vs. Wade — comes at a time of renewed attention to the importance of access to contraception. “I think there is absolutely more urgency today to have better access to contraceptives across the United States,” says Cynthia Harperprofessor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco.

Nearly 30% of women of childbearing age report a problem getting a prescription or refills for contraception, according to survey research published in 2016. Reasons include lack of insurance, not having a regular doctor, or difficulty making appointments. “There are absolutely barriers to contraception and access for people in this country,” says Dr. Jennifer Villavicence, who leads equity transformation at the American College of Obstetricians and Gynecologists (ACOG), which has approximately 60,000 members. She points to the logistical hurdles — or hassles — of seeing a doctor and also filling prescriptions. “Getting time off work, babysitting, driving, parking, all those things,” she says.

ACOG has supported access to over-the-counter hormonal contraceptives since 2012. The American Medical Association has also signaled his support. “Science and data have shown for some time that birth control is very safe to offer over-the-counter and doesn’t require a prescription,” says Villavicencio.

She cites other countries, including Mexico and many others in Latin America and Europe, which have opened up access to oral contraceptives by allowing the pills to be sold in pharmacies without a prescription. “Lessons from other countries that have had over-the-counter contraceptives have shown us that it works,” says Villavicencio. In 2021, HRA Pharma has obtained a license bring a birth control pill without a prescription into the UK as well.

HRA Pharma’s daily contraceptive 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 medical providers look for when prescribing birth control pills.

This lower-risk profile can make it easier to get an 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 Simonprofessor of clinical gynecology at Northwestern University.

The progesterone-only pill has a little less margin for error than the combination pill, which contains both estrogen and progesterone. “What that means is that you don’t have as much room to miss a pill or even mistime your pill,” says Villavicencio. And because of that, the efficiency with typical use drops to around 91%, according to the UK National Health Service. “It’s still very effective,” says Villavicencio.

HRA Pharma must meet a bunch of criteria to gain OTC approval in the United States. For example, it must provide evidence that individuals would be able to self-screen to determine if the pill was right for them. The company must also show that people can take the daily birth control pill as planned without a doctor’s explanation. “It’s something the pharmaceutical company has to prove through their data and their research,” says Free the Pill’s Nichols. She explains that the coalition has helped gather evidence over the past decade, which she says is solid. “We think these pills are safe and effective and people should be able to follow the simple instructions,” says Nichols.

In March, a group of lawmakers, including 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 requests for over-the-counter birth control pills without delay. Lawmakers have 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 people, youth, and people in rural communities – people who have faced and continue to face the most great inequalities,” the letter reads. Lawmakers said the FDA has an important role to play in reducing barriers to help provide people with greater control over their reproductive health.

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