OTC Birth Control Pill Sparks Surprising Debate

The FDA's potential authorization of the country's first over-the-counter birth control (OTC) is causing a sharp debate within the medical community.

Several medical organizations and reproductive health specialists support the approval of the Perrigo-manufactured medication Opill to be sold without a prescription. However, FDA scientists have raised numerous concerns about whether the pill should be available for over-the-counter use.

Added to the debate are Catholic groups who oppose the OTC pill on one side, while the Biden administration finds itself on the other side feeling pressure from those wanting more contraceptive options following the Supreme Court's decision last June to overturn Roe v. Wade.

On Wednesday, Opill came one step closer to authorization when two FDA advisory committees voted 17-0 in favor of making the pill available without a prescription. The FDA isn't required to make its final decision based on the committees' votes, but traditionally it has followed the guidance. The final FDA decision is expected to come this summer.

The concerns raised by FDA scientists include potential confusion about the pill's instructions, which require users to take the pill at the same time every day and either abstain from sex or use another form of birth control if they miss a dose. The agency has also noted that the data from HRA Pharma, the unit of Perrigo that makes the drug, is outdated since it came from when the pill was given prescription approval 50 years ago.

Politico reported that groups backing Opill approval's for OTC use expressed disappointment to press members on Monday about the FDA scientists' objections, saying their concerns "absolutely did not reflect what we know about the strong body of evidence on safety and effectiveness" of the medication.

Greer Donley, an associate professor at the University of Pittsburgh law school, spoke with Politico about the debate.

"I'm very aware [that] in this exact moment in time...we have just spent months...screaming 'the FDA is a scientific authority,' over and over and over again," Donley said. "It makes it harder for us to criticize [the FDA] when we think there are legitimate flaws with their decision."

Regarding how the White House will likely face harsh criticism whether the pill is approved or rejected, Donley said to Politico: "We're caught between a rock and a hard place."

During a hearing on Tuesday that included FDA scientists and Perrigo advisers, Dr. Carolyn Westhoff—an obstetrician-gynecologist at Columbia University's Mailman School of Public Health—spoke in favor of granting OTC approval for Opill.

"Despite availability of a variety of contraceptive methods, nearly half of the pregnancies are unintended every year," Westhoff said, according to The New York Times.

Westhoff also reportedly discussed how current OTC methods are less effective than birth control pills and allowing Opill to be available without a prescription would benefit adolescents who face the "most significant barriers to accessing the more effective methods."

Meanwhile, the U.S. Conference of Catholic Bishops, National Catholic Bioethics Center, Catholic Medical Association and National Association of Catholic Nurses wrote a joint letter to the FDA's advisers in November that outlined their objections to making Opill available without a prescription.

The letter noted potential side effects of the contraception, such as abnormal bleeding, ovarian cysts and depression.

"Making such a potentially harmful medication available without a prescription can only cause avoidable harm," the letter said. "We...strenuously oppose the non-prescription availability of Opill."

One group that is not expected to get involved at this time is the Alliance Defending Freedom (ADF). The legal advocacy group helped write the Mississippi law which the Supreme Court used to overturn Roe v. Wade, as well as filed a lawsuit against the FDA last year in an attempt to reverse the agency's approval of the abortion medication mifepristone.

"We continue to call upon the FDA to put the health and safety of women and girls first, put science and good medicine over politics, and follow the law," Denise Harle, senior counsel with ADF, told Newsweek. "We have no plans to litigate if FDA decides to disregard its own scientists and grant final approval of the OTC birth control pill."

When reached for comment, a representative for the FDA referred Newsweek to video clips of advisory hearings.