US FDA to weigh over-the-counter birth control pill

The US Food and Drug Administration (FDA) has received its first application to supply a birth control pill over the counter, rather than by prescription weeks after the Supreme Court overturned Roe vs Wade.

Paris-based pharmaceutical company HRA Pharma submitted an application to the FDA on Monday. It said the timing of its application is unrelated to the June 24 Supreme Court decision.

The contraceptive is currently a prescription drug sold under the brand name Opill. If approved, Opill would become the first daily hormonal birth control pill sold over the counter in the US, broadening access to millions of people.

"This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the US," Frédérique Welgryn, the company's chief strategic and innovations officer, said in a statement.

Oral contraceptives have been widely used in the US since the 1960s. The FDA is expected to make a decision next year, according to the company. The approval will apply only to the company's Opill drug, which has been used with a prescription since FDA approval in 1973.

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

Meanwhile, US Health and Human Services Secretary Xavier Becerra wrote in a letter to healthcare providers on Monday that physicians must provide abortions in medical emergencies under federal law and will face penalties if they decline to offer the procedure in these cases.

He said federal law pre-empts state abortion bans in cases where women face medical emergencies associated with pregnancy under the Emergency Medical Treatment and Active Labor Act. If an abortion is necessary to treat a woman facing a medical emergency, physicians must offer the procedure, the health secretary wrote.

Hospitals that decline to provide abortions in these cases could have their Medicare provider agreement terminated or face financial penalties, Becerra said. Individual physicians could also be cut from Medicare and state health programs if they refuse to offer abortions in medical emergencies, he added. Physicians can also use federal law as a defense if they face state prosecution when providing abortions in emergencies, according to HHS.

Before submitting its application, the company had been studying thousands of subjects for more than six years to prove to the FDA that people could understand a drug's label and use it properly without a doctor's guidance, Politico reported.

The timing of HRA Pharma's FDA. Submission shortly after the Supreme Court decision is "a really sad coincidence", Welgryn told The New York Times. "Birth control is not a solution for abortion access."

According to the Times, Cadence Health, another pill manufacturer that has been in close dialogue with the FDA about switching its pill to over-the-counter status, said it hopes to move closer to submitting an application in the coming year.

The only contraception pill available for women without a prescription is the emergency oral pill that can be taken within three days after having unprotected sex.

Globally, more than 100 countries provide oral contraceptives without a prescription, making the US one of the few countries to require one.

Last month, the American Medical Association called on the FDA to make birth control pills available over the counter to Americans, without an age restriction.

In March, more than 50 House Democrats wrote to FDA Commissioner Robert Califf to urge the agency to approve over-the-counter birth control pills.

Late last year, the FDA eased access to the abortion pill, and the agency was condemned by abortion opponents and praised by women's rights advocates. The agency faced similar political pressure in 2006 when it approved over-the-counter use of the emergency contraception pill Plan B.