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French Pharmaceutical Company Applies to Sell Over-The-Counter Birth Control Pills in America

Oral contraceptive pills are only available with a prescription in the United States

The Food and Drug Administration could approve an application from a French pharmaceutical company that wants to make birth control pills available without a doctor’s prescription.

The application form HRA Pharma would be the first of its kind in the United States.

“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,”  Frédérique Welgryn, the company’s chief strategic operations and innovation officer, said in a July 11 statement.

“More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant,” added Welgryn. “Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”

HRA Pharma has asked the FDA to move its once-daily progestin birth control pill Opill from prescription medication designation to an OTC product that women can access without needing to consult a doctor.

The company says over 6.1 million unintended pregnancies occur annually in America and that increasing access to and available methods of contraception “will increase the likelihood of using effective birth control methods.”

“Removing the prescription requirement with Opill would improve access to a contraceptive method that is well tolerated and notably more effective at preventing pregnancy than all current methods available OTC,” stated HRA.

The FDA first approved Opill for prescription use in 1973.

Medical organizations, including the American College of Obstetricians and Gynecologists and the American Medical Association, have called for the non-prescription oral contraceptive to be made available to consumers. 

A regulatory pathway exists at the FDA for converting oral contraceptives from prescription products to OTC products and a required manufacturer application for a switch is expected to be submitted before the end of 2022,” the American Medical Association said in a press release in June.

“Providing patients with OTC access to the birth control pill is an easy call from a public health perspective as the health risks of pregnancy vastly outweigh those of oral contraceptive use,” added Dr. David Aizuss, a board member of the organization. “Expanding OTC access would make it easier for patients to properly use oral contraceptives, leading to fewer unplanned pregnancies.”

Oral contraceptives have been the most commonly used form of birth control since they were initially approved by the FDA in the 1960s.

According to data from the Centers for Disease Control and Prevention, 14% of women between the ages of 15-19 use the birth control pill as a form of contraceptive. About 10% use a long-acting reversible contraceptive such as an intrauterine device.

The Kaiser Family Foundation, a national health issues nonprofit, reports that “White women are more likely to use [Oral Contraceptive Pills] than Hispanic or Black women” and that  “OCP use increases with higher educational attainment.”

While HRA Pharma’s application came weeks after the Supreme Court overturned federal protections for abortion, the company has been working on providing an over-the-counter birth control pill for almost six years. In December of 2016, HRA Pharma and Ibis Reproductive Health announced they would partner to “conduct the research needed” to apply for an Rx-to-OTC switch with the FDA.

“This is an exciting step forward in our work to increase access to reproductive health care and improve women’s ability to access safe and effective contraceptive methods,” Ibis Reproductive Heath said in a press release at the time. “Too many people in the United States face barriers to accessing the contraceptive methods they want; a safe and effective hormonal birth control pill available over the counter would improve access and help people overcome some of those barriers.”

In 2019, Republicans in the Senate introduced a law to expedite the approval process for drug makers applying to have their hormonal birth controls made into OTC products.

Senator Joni Ernst of Iowa and Senator Cory Gardner of Colorado introduced the Allowing Greater Access to Safe and Effective Contraception Act which would have required the Health and Human Services Secretary to give priority to applications for applicable medications. The lawmakers also wanted to end the tax on over-the-counter medications.

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