First U.S. Application for Over-the-Counter Birth Control Pill

SInce, the Supreme Court was overturnedRoe V. WadeAccess to contraception is now more important than ever. This has triggered a series of bans on abortion in the United States. Patients still require a prescription to obtain birth control pills or other hormonal contraceptives within the United States. However, birth control pills now have a chance to be sold over the counter.

French drugmaker HRA Pharma has applied to the U.S. Food and Drug Administration for the first ever over-the-counter contraceptive pill.

“We’re very proud of being the first company to submit the first-ever application to the FDA for daily birth control over the counter, and obviously it’s coming at the right moment,” says Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma. Although the company had been working on its application for years before the Supreme Court’s decision, the announcement is “a bit of light in this very dark moment” for reproductive rights in the U.S., Welgryn says.

Unintended pregnancies account for nearly half of all U.S. pregnancies. Research also shows that almost one-third of those who tried prescription birth control have encountered obstacles. 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 throughout the country, especially for poor people, those in rural areas, and other marginalized communities.

The FDA approved oral contraceptives for the first time more than 60 year ago. They are still the most widely used non-permanent form of birth control in America. They are available in over 100 countries. Data for Progress polls show that Americans, regardless of party affiliation, support making birthcontrol pills accessible without the need for a prescription.

FDA requires that any medication sold under the oath in America must be safe. It must also treat a condition the user can diagnose, has a low risk of misuse and be easy to use.

Many researchers and major medical associations in the U.S. say oral contraceptives meet all of the FDA’s requirements. American College of Obstetricians and Gynecologists and American Academy of Family Physicians (AMA), have all supported the sale of contraceptives over the counter over many years. Last month, the AMA urged FDA to grant over-the–counter access to birth control pills to everyone without age restrictions.

While millions of people take birth control pills every year and research has shown they are safer than pregnancy—which carries a higher risk of blood clots, among many other issues—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 sales are for pills that include both estrogen and progesterone, but HRA Pharma’s pill, called Opill, contains only progestin. Research has shown that progestin pills that are only available in the form of progestin do not have an increase risk for blood clots.,HRA Pharma may have been the first company that was ready to file with FDA.

The FDA has never received a request from any company to transfer its contraceptive pill. HRA Pharma is working towards its application since around seven years. Cadence Health, a company that also works with FDA, has worked for many years on preparing an over-the counter pill. Times reported last year, though Cadence hasn’t yet submitted its application.

There are likely several reasons that it’s taken years for pharmaceutical companies 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 an overall trend of large pharmaceutical companies reducing their investment in women’s health, and especially in contraceptives. Because the market for birth control is largely made of generic drugs, it does not bring in the same large revenue as more specialty drugs. Over-the-counter drugs in the U.S. tend to be used for acute conditions and not on an ongoing basis like birth control pills. Drugmakers may be cautious about trying out new products. Blanchard points out that there may still be stigma associated with sexual and reproductive issues, which might have discouraged some companies from seeking an over-the–counter medication.

FDA stated that it will make a decision on a request to transfer a drug from prescription status to over-thecounter status within 10 months. HRA Pharma therefore expects to find out if the company’s pill has been approved or rejected in the first quarter of 2023.

One remaining question will be the pill’s cost. It’s too soon to know the exact price, but HRA Pharma has started discussions with retailers, Welgryn says, and it plans to create a program that would offer financial assistance. “We’re committed to making the pill affordable for all those who need it,” she says.

The Affordable Care Act mandates that all FDA-approved methods of birth control be covered by most insurance policies. However, many insurers will only pay for birth control that has been prescribed by a doctor. (And even then, some health insurers have been denying coverage for birth control or imposing costs—an issue that congressional Democrats and the Biden Administration have recently sought to address as abortion access is curtailed around the country.)

Recently, both the Senate and the House Democrats reintroduced legislation to mandate that insurers cover over-the counter birth control. Ibis Reproductive Health will advocate for the FDA to approve the coverage of the new pill to ensure it is covered by their insurers. “One of our key goals is to ensure coverage for over-the-counter contraceptives,” Blanchard says. It has been able to expand birth control coverage in some states and will continue to advocate for employers and insurance companies to cover the over-the-counter pills. “We are hopeful that we will move towards it being more common for insurance to cover it,” she adds, “because it’s really important for access and affordability that insurance does cover an [over-the-counter] pill.”

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

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