Since the Supreme Court overturned Roe v. Wade, triggering a chain reaction of abortion bans across the country, access to contraception has become increasingly important. Patients in the United States still require a prescription to obtain birth control pills and other hormonal contraceptives. Birth control pills, on the other hand, are one step closer to being available over the counter.
HRA Pharma, a French pharmaceutical company, has applied to the US Food and Drug Administration (FDA) for the first over-the-counter birth control pill in the country.
“We’re very proud of being the first company to submit the first-ever application to the FDA for over-the-counter daily birth control, and it obviously comes at the right time,” says Frédérique Welgryn, HRA Pharma’s chief strategic operations and innovation officer.
Despite the fact that the company had been working on its application for years prior to the Supreme Court’s decision, Welgryn describes the announcement as “a bit of light in this very dark moment” for reproductive rights in the United States.
Birth Control Pills Without a Prescription in The United States
Almost half of all pregnancies in the United States are unintended, and research shows that nearly one-third of women who attempted to obtain prescription birth control 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 across the country, particularly for the poor, rural residents, and other marginalized groups.
Oral contraceptives were approved by the FDA more than 60 years ago and are now the most widely used non-permanent method of birth control in the United States. The pills are already available without a prescription in over 100 countries.
According to recent Data for Progress polling, the majority of American voters across party lines support making birth control pills available without a prescription in the United States.
To be sold over the counter in the United States, a medication must be safe, treat a condition that users can self-diagnose, have a low potential for misuse, and be something people can use effectively without the supervision of a health care provider, as per the FDA.
Oral contraceptives, according to many researchers and major medical associations in the United States, meet all of the FDA’s requirements. For several years, organizations such as the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, and the American Medical Association (AMA) have advocated for the FDA to approve over-the-counter access to birth control pills without an age restriction.
While millions of people use birth control pills each year, and research has shown that they are safer than pregnancy—which has a higher risk of blood clots, among other problems—there are some risks for people with certain medical conditions, which is why oral contraceptives have traditionally required a prescription.
The vast majority of oral contraceptive pills sold contain both estrogen and progesterone, but HRA Pharma’s Opill pill contains only progestin.
According to studies, most progestin-only pills are not associated with an increased risk of blood clots, which may explain why HRA Pharma was the first company to be prepared to file an application with the FDA.
No company has previously applied to the FDA to make its birth control pill available over the counter. HRA Pharma has been working on its application for about seven years, and Cadence Health has also been working with the FDA for years to prepare an over-the-counter pill, according to the New York Times last year, though Cadence has not yet submitted its application.
According to Kelly Blanchard, president of Ibis Reproductive Health, a research and advocacy group that has worked closely with HRA Pharma, there are likely several reasons why pharmaceutical companies have taken so long to reach this point.
First, large pharmaceutical companies have been decreasing their investment in women’s health, particularly in contraception. Because the birth control market is dominated by generic drugs, the products do not generate the large revenues that more specialized drugs can.
Most over-the-counter medications in the United States are also intended to treat acute symptoms rather than be used on a regular basis, as birth control pills are, and drugmakers can be wary of experimenting with new ideas.
Finally, Blanchard points out that the continued stigma surrounding sexual and reproductive health may have discouraged some companies from developing an over-the-counter pill.
The FDA has stated that once a company submits an application to move a drug from prescription to over-the-counter status, it will make a decision within 10 months, so HRA Pharma expects to know whether its pill is approved in the first half of 2023.
One remaining question is how much the pill will cost. It’s too early to know the exact price, but HRA Pharma has begun discussions with retailers and plans to create a financial assistance program, according to Welgryn. “We are dedicated to making the pill affordable for all who require it,” she says.
While the Affordable Care Act requires most health insurance plans to cover all FDA-approved birth control methods with no out-of-pocket costs, most insurers only cover birth control that has been prescribed by a health care provider.
Even so, some health insurers have denied coverage for birth control or imposed fees—an issue that congressional Democrats and the Biden Administration have recently sought to address as abortion access is being restricted across the country.
Democrats in the House and Senate recently reintroduced legislation requiring insurers to cover over-the-counter birth control, and Ibis Reproductive Health intends to lobby insurers to cover the new pill if it is approved by the FDA.
One of our primary goals is to ensure coverage for OTC contraceptives, Blanchard says.
The organization has had some success expanding birth control coverage at the state level and intends to make the case to insurers and employers that an over-the-counter pill should be covered. “We are hopeful that it will become more common for insurance to cover it,” she adds, “because it is critical for access and affordability that insurance does cover a [over-the-counter] pill.”
Nonetheless, while HRA Pharma’s application represents an important step forward in birth control access in the United States, Welgryn emphasizes that even if the FDA approves their application, the pill isn’t a cure-all.
“We know that people need access to the full range of reproductive health care,” she says, “which includes contraception, abortion, and everything else women need to control their reproductive lives.”