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Drugmaker seeks FDA approval of over-the-counter contraceptive pill: Shots

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

Peter Dazeley/Getty Images

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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 assessment process is estimated to take approximately 10 months.

Peter Dazeley/Getty Images

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

“This could be a truly groundbreaking change in access,” said Victoria Nichols of Free the Pill, a coalition of advocates, researchers and healthcare providers that helped build the groundwork and support for regulatory approval of over-the-counter pill options in the United States. United States.

The coalition’s work began more than a decade ago, but the application for approval – filed in the wake of the overthrow of Roe v. Wade — comes at a time of renewed focus on the importance of access to contraception. “I think there is definitely more urgency these days to have better access to birth control in the United States,” said 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 getting a birth control prescription or refills, according to survey research published in 2016. The reasons include not having insurance, not having a regular doctor, or having trouble making an appointment. “There are definitely barriers to birth control and access for people in this country,” said Dr. Jennifer Villavicencio, chief of stock transformation at the American College of Obstetricians and Gynecologists (ACOG), which has about 60,000 members. She points out logistical obstacles — or hassles — of seeing a doctor and filling prescriptions. “Taking time off, arranging childcare, 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 expressed its support. “The science and data has shown for some time that birth control is very safe to offer without a prescription and does not require 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 selling the pills over the counter in pharmacies without a prescription. “Lessons learned from other countries that have had over-the-counter birth control have shown us that it works,” Villavicencio says. In 2021, HRA Pharma was licensed to also bring a non-prescription contraceptive pill to the UK.

HRA Pharma’s daily contraceptive pill is called Opill. Because it does not contain the hormone estrogen, it has a lower risk of blood clots, which is a risk factor that healthcare providers look for when prescribing birth control pills.

This lower-risk profile can make it easier to get 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,” said Dr. Melissa Simon, a professor of clinical gynecology at Northwestern University.

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

HRA Pharma must meet a number of criteria to gain over-the-counter approval in the United States. For example, it must show that individuals can screen themselves to determine whether the pill is right for them. The company must also demonstrate that people without a doctor’s certificate can take the daily contraceptive pill as intended. “That’s what the drug company has to prove through their data and research,” says Free the Pill’s Nichols. She explains that over the past decade, the coalition has contributed to the collection of evidence, which she says is strong. “We believe that these pills are safe and effective and people should be able to follow the simple instructions,” Nichols says.

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 inequalities in the health care system that hinder access. “These barriers are disproportionately borne by people of color, immigrants, LGBTQ+ people, low-income people, youth and people in rural communities – individuals who have faced and continue to face the greatest inequality,” the letter reads. Lawmakers said the FDA has an important role to play in reducing barriers to give people more control over their reproductive health.

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

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