First U.S. Application for Over-the-Counter Contraceptives

Sto the supreme court overturned Roe v. Wade and imposed a series of abortion bans across the country, access to contraception became increasingly important. To get birth control pills and other American hormonal contraceptives, patients still need a prescription. But now the birth control pill is one step closer to being 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 US.

Frédérique Welgryn, director of strategic operations and innovation at HRA Pharma. While the company worked on its application for years before the Supreme Court decision, the announcement is “a bit of light in this very dark time” for reproductive rights. in the US, Welgryn said.

Nearly half of all pregnancies in the US are unintended, and research shows almost a third of women who have tried to access prescription contraceptives have encountered obstacles. If HRA Pharma’s application is approved, reproductive rights activists and researchers argue that the over-the-counter drug will remove barriers to healthcare and expand access to health care. birth control across the country, especially for the poor, those in rural areas and other marginalized communities.

Oral contraceptives were first approved by the FDA over 60 years ago, and they are most popular Non-permanent birth control in the United States The drug is available over the counter in more than 100 Nation. And recent poll from Data for Progress shows that a majority of US voters across party lines support the provision of over-the-counter birth control pills in the US

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For a drug to be sold over-the-counter in the U.S., the FDA says it must be safe, treat a condition that users can self-diagnose, have a low potential for abuse, and be something people can’t afford. can be used effectively. without the supervision of a healthcare provider.

Many researchers and major medical associations in the US say the pill meets all of the FDA’s requirements. Groups include American College of Obstetricians and Gynecologiststhe American Academy of Family Physiciansand the American Medical Association (AMA) have been supporting the shift of birth control pills over the counter for several years, and the AMA last month urge FDA to approve the right to use over-the-counter drugs without age restrictions.

While millions of people take birth control pills each year and research has shown them to be safer during pregnancy – which carries a higher risk of blood clots, among many other problems – there are some risks to these women. people with certain medical conditions, which is why oral contraceptives traditionally require a prescription. The majority of oral contraceptive sales are for pills that include 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, that may be part of why HRA Pharma is the first company willing to file with the FDA.

Previously, no company had applied to the FDA to move birth control pills over the counter. HRA Pharma has been working towards its application for about seven years, and another company called Cadence Health has also worked with the FDA for many years to get an over-the-counter drug ready, New York Times report last year, although Cadence has yet to submit an application.

According to Kelly Blanchard, president of Ibis Replictive Health, a research and advocacy group that has worked closely with HRA Pharma, there are a number of reasons it took pharmaceutical companies years to get to this point. First, there has been a general trend of large pharmaceutical companies reducing their investment in women’s health, and especially in contraceptives. The birth control market is comprised of many generic drugs, so the products don’t generate the kind of big sales that more specialized drugs can. Most over-the-counter drugs in the U.S. are also intended to treat acute symptoms rather than being used consistently the way birth control pills do, and drug manufacturers can be wary of trying new ideas. Finally, Blanchard notes that the lingering stigma surrounding sexual and reproductive health may have prevented some companies from pursuing the over-the-counter drug.

The FDA says it aims to make a decision within 10 months of a company’s application to move a drug from prescription to over-the-counter status, so HRA Pharma expects to know if its drug is effective. approved in the first half of 2023. .

One remaining question will be the cost of the pill. It’s too early to know the exact price, but HRA Pharma has already begun discussions with retailers, Welgryn said, and they plan to create a program to provide financial assistance. “We are committed to making the pill affordable for everyone who needs it,” she said.

While the Affordable Care Act requires most health plans to cover all FDA-approved birth control methods with no out-of-pocket costs, most insurers only pay for birth control prescribed by a health care provider. (And even then, some health insurance companies have deny coverage for birth control or impose costs—An issue that congressional Democrats and the Biden administration have recently sought to address as access to abortion is restricted across the country.)

Recent House and Senate Democrats reintroduce the law aims to require insurance companies to cover over-the-counter birth control, and Ibis Replictive Health plans to lobby insurers to cover the new pill if the FDA approves it. “One of our main goals is to secure coverage for over-the-counter contraceptives,” says Blanchard. The group has had some success expanding birth control coverage at the state level and plans to make a case with insurers and employers that they should cover the drug. prescription. “We hope that we will move towards making it more common for insurance to cover it,” she added, “because that is really important to accessibility and affordability.” insurance pays for a [over-the-counter] Pill.”

However, while HRA Pharma’s application marks an important milestone in accessing birth control in the United States, Welgryn stressed that even if the FDA approves their application, the pill does not must be a panacea. “We know that everyone should have access to a full range of reproductive health care and including contraception, including abortion, including all that women need to be healthy,” she said. control their reproductive lives.”

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