Drug company pitches FDA to make birth control pill formerly owned by Pfizer available OTC

The French pharmaceutical company HRA Pharma has just petitioned the FDA to sell over the counter a contraceptive pill that was once owned by Pfizer.

Though birth control pills have been widely available since the 1960s, American women have always needed a prescription in order to access them because they may increase the risk of blood clots. However, HRA Pharma now argues that women should be able to weigh those risks for themselves without the hassle of consulting a physician.

“For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available,” said Frédérique Welgryn, HRA Pharma's chief strategy officer.

The pill, originally called Opill, has been available via prescription since 1973, and HRA acquired Opill from Pfizer back in 2014. On Monday, just weeks after the United States Supreme Court overturned Roe v. Wade, HRA submitted the application to take Opill over the counter. Still, HRA insists that the timing is a coincidence — "a really sad coincidence," according to Welgryn, who says that "[b]irth control is not a solution for abortion access."

That hasn't stopped some pro-abortion and pro-contraception advocates from supporting HRA Pharma's proposal.

"This is an exciting moment for the coalition," says a group which calls itself Free the Pill. "[I]n July 2022, HRA Pharma announced that it has submitted the first-ever application to the FDA to switch Opill, a progestin-only, daily birth control pill from prescription to over-the-counter status. Free the Pill celebrates this important milestone and looks forward to continuing to work with coalition members to ensure that future OTC birth control pills are affordable, fully covered by insurance, and accessible to people of all ages in the United States."

Members of the Free the Pill "coalition" include the ACLU, the American College of Obstetricians and Gynecologists, Guttmacher Institute, NARAL Pro-Choice America, and Planned Parenthood Federation of America.

Free the Pill and HRA Pharma both claim that about one-third of women who have sought a prescription for oral contraceptives have faced obstacles. They argue that an OTC option will liberate women from these obstacles and help them maintain their economic productivity without having to sacrifice an active sex life.

Contraceptive use has been linked to "fuller participation in the workforce, career advancement, and greater economic well being" for women, a video on the Free the Pill website boasts.

PBS claims that the FDA could make a decision on the HRA Pharma proposal as early as next year. If it is approved, Opill will become the first birth control pill in the U.S. to be available over the counter.