First U.S. demand for the over-the-counter birth control pill

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Ssince the Supreme Court overturned Roe vs. Wade and triggered a cascade of nationwide abortion bans, access to contraception took on increased importance. To obtain birth control pills and other hormonal contraceptives in the United States, patients still need a prescription. But now birth control pills are about to be available over the counter.

HRA Pharma, a French drugmaker, has filed an application with the US Food and Drug Administration (FDA) for the first over-the-counter birth control pill in the United States

“We are very proud to be the first company to submit the first-ever FDA application for an over-the-counter daily contraceptive, and it obviously comes at the right time,” said Frédérique Welgryn, Director of Strategic Operations and innovation at HRA Pharma. Although the company worked on its application for years before the Supreme Court’s decision, the announcement is “a bit of light at this very dark time” for reproductive rights in the United States, Welgryn says.

Nearly half of pregnancies in the United States are unintended, and research shows that almost a third of women who have tried to access prescription contraception have encountered barriers. If HRA Pharma’s application is approved, reproductive rights activists and researchers say an over-the-counter pill would remove barriers to health care and expand access to birth control nationwide, especially for children. poor, those in rural areas and other marginalized communities. .

Oral contraceptives were first approved by the FDA over 60 years ago, and they are the the most popular non-permanent method of birth control in the United States. The pills are already available over-the-counter in the United States. over 100 countries. And recent survey of Data for Progress shows that the majority of American voters of all parties support the availability of birth control pills without a prescription in the United States

For a drug to be sold without a prescription in the United States, the FDA states that it must be safe, must treat a condition that users can self-diagnose, must have low potential for abuse, and must be something that people can use effectively. without the supervision of a health care provider.

Many researchers and major medical associations in the United States claim that oral contraceptives meet all FDA requirements. groups whose American College of Obstetricians and Gynecologiststhe American Academy of Family Physiciansand the American Medical Association (AMA) have supported the displacement of birth control pills without a prescription for several years, and the AMA last month urged the FDA to approve access to over-the-counter pills with no age limit.

While millions of people take birth control pills each year, and research has shown them to be safer than pregnancy – which carries a higher risk of blood clots, among many other problems – there are certain risks for people with certain medical conditions, which is why oral contraceptives have traditionally required a prescription. The vast majority of sales of birth control pills are pills containing both estrogen and progesterone, but HRA Pharma’s pill, called Opill, contains only progestin. Most progestin-only pills are not associated with an increased risk of blood clots, studies have shown, which perhaps partly explains why HRA Pharma was the first company to be ready to apply to the FDA.

No company has ever submitted an application to the FDA to sell its birth control pill over the counter. HRA Pharma has been working on its application for about seven years, and another company called Cadence Health has also been working with the FDA for years to make an over-the-counter pill, the New York Time reported last year, although Cadence has not yet submitted its application.

There are likely several reasons why it took pharmaceutical companies years to get to this point, says Kelly Blanchard, president of Ibis Reproductive Health, a research and advocacy group that has worked closely with HRA Pharma. First, there has been a general trend by big pharma to reduce their investments in women’s health, and in contraceptives in particular. The birth control market is made up of many generic drugs, so the products do not generate the significant types of revenue that more specialized drugs can. Most over-the-counter drugs in the United States are also meant to treat acute symptoms rather than be taken continuously like birth control pills, and drugmakers may be hesitant to try new ideas. Finally, Blanchard notes that lingering stigma around sexual and reproductive health may have deterred some companies from seeking an over-the-counter pill.

The FDA said it aims to make a decision within 10 months once a company submits an application to move a prescription drug to over-the-counter status, so HRA Pharma expects find out if his pill is approved in the first half of 2023.

A remaining question will be the cost of the pill. It’s too early to know the exact price, but HRA Pharma has started discussions with retailers, Welgryn says, and plans to create a program that would offer financial assistance. “We are committed to making the pill affordable for everyone who needs it,” she says.

While the Affordable Care Act requires most health insurance plans to cover all FDA-approved birth control methods free of charge, most insurers only cover birth control prescribed by a healthcare provider. health. (And even then, some health insurers have refused to cover birth control or imposed costs — an issue that congressional Democrats and the Biden administration have recently sought to address as abortion access is restricted nationwide.)

Democrats in the House and Senate recently reintroduced legislation which aims to require insurers to cover over-the-counter contraceptives, and Ibis Reproductive Health plans to advocate with insurers to cover the new pill if the FDA approves it. “One of our main goals is to provide coverage for over-the-counter contraceptives,” says Blanchard. The group has succeeded in expanding birth control coverage statewide and plans to advocate to insurers and employers that they should cover an over-the-counter pill. “We’re hoping we’re going to make it more common for insurance to cover it,” she adds, “because it’s really important for access and affordability for insurance to cover a [over-the-counter] pill.”

Still, while HRA Pharma’s application marks a milestone in access to birth control in the United States, Welgryn points out that even if the FDA approves their application, the pill is not a panacea. “We know that people need access to the full range of reproductive health care,” she says, “and that includes contraception, which includes abortion, which includes the full range of what women need. need to control their reproductive life”.

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Write to Abigail Abrams at abigail.abrams@time.com.

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