The lawmakers pointed to systemic inequities in the health care system that create barriers to access. 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. "We believe that these pills are safe and effective and that people should be able to follow the simple instructions," says Nichols. She explains that the coalition has helped build evidence over the last decade, which she says is strong. "That's something the pharmaceutical company has to prove through their data and research," says Free the Pill's Nichols. The company must also show that people could take the daily contraceptive pill as intended without a doctor's explanation. For instance, it must provide evidence that individuals would be able to screen themselves to determine whether the pill was right for them. HRA Pharma must meet a bunch of criteria to win over-the-counter approval in the United States. "That is still very effective," 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. "What that means is you don't have as much room to miss a pill or to even mistime your pill," says Villavicencio. The progesterone-only pill has a little bit less room for error than the combined pill, which has both estrogen and progesterone in it. Melissa Simon, a professor of clinical gynecology at Northwestern University. "The progesterone-only pill as the first over-the-counter pill in the United States would make a lot of sense," says Dr. This lower-risk profile may make it easier to win over-the-counter approval. 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. HRA Pharma's daily birth control pill is called Opill. In 2021, HRA Pharma received a license to bring a nonprescription contraceptive pill to the United Kingdom too. "The lessons learned from other countries who have had over-the-counter birth control have shown us that it works," 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 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. The American Medical Association has also signaled its support. "Taking time off work, getting child care, driving, parking, all of those things," she says.ĪCOG has supported access to over-the-counter hormonal contraceptives since 2012. She points to logistical obstacles - or hassles - to seeing a doctor and filling prescriptions as well. Jennifer Villavicencio, who heads equity transformation at the American College of Obstetricians and Gynecologists (ACOG), which has about 60,000 members. "There absolutely are barriers to contraception and access for people in this country," says Dr. The reasons include lack of insurance, not having a regular doctor or challenges making an appointment. Nearly 30% of women of childbearing age report a problem obtaining a birth control prescription or refills, according to survey research published in 2016. "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. Wade - comes at a time of renewed attention to the importance of contraception access. 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. "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. If approved, it would be the first oral contraceptive available in the U.S. The pill includes progestin only, not estrogen, and is known as a mini pill. Food and Drug Administration for an over-the-counter birth control pill. The agency's review process is estimated to take about 10 months.Ī pharmaceutical company based in Paris, HRA Pharma, is seeking approval from the U.S. Drugmaker HRA Pharma has asked the Food and Drug Administration to approve an over-the-counter birth control pill called Opill.
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