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July 12, 2022

French drugmaker asks FDA to approve first over-the-counter birth control pill

Oral contraceptives have been available for more than 50 years, but only via prescription

A birth control pill could be sold over the counter for the first time in the United States if the Food and Drug Administration approves a request by a French drugmaker. 

HRA Pharma has submitted an application to the FDA requesting Opill, a progestin-only, daily oral contraceptive, be switched from a prescription drug to an OTC medication. More than 100 countries sell birth control pills over the counter. 

Oral contraceptives have been available in the U.S. on a prescription-basis only for more than 50 years. Still, nearly half of the more than 6.1 million pregnancies in the U.S. each year are unintended. 

"Moving a safe and effective prescription birth control to OTC will help even more women and people access contraception without facing unnecessary barriers," said Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma. 

The pill called Opill contains a synthetic form of the hormone progesterone, which prevents pregnancy by blocking sperm from the cervix. It was approved on a prescription-only basis by the FDA in 1973 and marketed at first by Pfizer. HRA Pharma acquired it in 2014, but it has not been sold in the U.S. in more than 10 years.

The submission comes less than three weeks after the Supreme Court overturned Roe v. Wade, which made abortion a constitutional right for women. HRA Pharma executives called the timing of the submission coincidental. The company spent several years completing the pre-application process.

"It will provide another option for managing reproductive health," Welgryn told the Washington Post. "But it is not the solution for abortion access." 

Cadence Health, based in Oakland, California, also has been working on a non-prescription oral contraceptive. Its pill is combination of progesterone and estrogen.

Many women's health groups and medical organizations, including as the American Medical Association and the American College of Obstetricians and Gynecologists, have supported making birth control pills available over the counter for years. 

And in March, more than 50 members of the U.S. House's Pro-Choice Caucus, including Congresswoman Mary Gay Scanlon, wrote a letter to FDA Commissioner Robert Califf urging the agency to approve the sale of oral contraceptives without a prescription.

"This is a critical issue for reproductive health, rights and justice," the lawmakers wrote. "We ask for your ongoing commitment to advance public health and follow the science and data in all decisions, including the timely review of the oral contraception applications."

They also emphasized the need for no age restrictions. The age requirement for Plan B., the emergency contraception pill, was lifted in 2013. It was first approved in 2006.

One of the reasons prescriptions are required for birth control pills is to ensure people are screened for conditions that can increase the risk of blood clots. Though rare, they can be life-threatening. 

HRA Pharma has been conducted seven years of research that show people can safely screen themselves for those risks. The company conducted a clinical trial that followed 1,000 women who took Opill for six months.

"Oral contraceptives are safe, and they are safe medications for most people," Dr. Jonas Swartz, an obstetrician and gynecologist at Duke University Health System, told The New York Times, "There's good data that people can do screening with, either online tools or checklists, to determine if they are not candidates for using combined pills or progestin-only pills."

Most oral contraceptives are so-called combination pills that contain progestin and estrogen, which helps make periods lighter and regular, according to the Associated Press. Progestin-only pills, like Opill, are recommended for people with health issues that prevent them from taking combination pills.

Other prescription medicines that made the move from prescription to being sold over the counter include drugs for pain relief, heartburn and allergies. In order to make the switch, the companies had to prove that consumers could understand the labeling on the drug, evaluate any potential risks and use the medication safely and effectively without supervision from a health care provider.

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