May 10, 2023 -- Advisors from the FDA made strides today toward approving the country’s first over-the-counter birth control pill, voting unanimously that widening the pill’s availability would provide more benefits than harm.
The FDA approval of the oral contraceptive Opill – a 0.075mg daily tablet also called the “mini pill” as it only contains the hormone progestin (rather than a combination of progestin and estrogen) – could happen as soon as this summer. While the agency is not bound by the advisory panel’s recommendations, a 17-0 vote will lend serious credence to the pill.
HRA Pharma, the French drug company that makes Opill, is calling for the FDA to approve the drug for all reproductive females -- including teenagers.
The major areas of concern for some on the advisory committee were how making pill available over-the-counter option would affect certain vulnerable populations, including adolescents and those with limited literacy capabilities. Questions came up again and again about the public’s ability to understand and adhere to the medication’s instructions.
Annie Frisse, MD, MPH, an OB-GYN and assistant professor at Mount Sinai Hospital in New York, says that over-focusing on this potential problem does a disservice to patients nationwide.
“We expect our patients for any type of medication to be able to read a pill label and administer the medication appropriately,” Frisse said. “For example, Tylenol, when taken incorrectly can be extremely dangerous, but we trust our patients to take that over the counter appropriately and not overdose or harm themselves with those pills.”
And with a contraceptive proven as safe as the progesterone-only pill, the expectation is no different. With this type of birth control, adherence to the pill’s schedule (taken once at the same time daily) is crucial to its effectiveness, as its “missed-pill window” is more narrow than the combination pills that include estrogen.
But as Elise Berlan, MD, a member of the FDA committee and pediatrician at Nationwide Children's Hospital in Columbus, OH, noted, adherence is “highly imperfect” even with prescription drugs.
“Adolescents can adhere to daily contraceptive use… Non-adherent daily dosing is likely to compromise effectiveness but it’s unlikely to pose harm greater than non-use,” Berlan said.
Other concerns centered around breast cancer patients or those with a history of the disease, citing that some women may not know they shouldn’t take birth control pills if they fall into one of those categories. But FDA advisors stressed that many women are aware of this precaution and adjust their usage accordingly.
According to a study conducted by HRA Pharma, the most common side events related to the consistent use of Opill was abnormal vaginal bleeding and menstrual irregularity, neither of which exceeded more than 5% of users.
The stakes are high for the FDA’s final ruling, as it would come almost a year after the overturning of Roe V. Wade, which previously guaranteed a woman’s constitutional right to an abortion.
“At this tumultuous time for reproductive health in the United States, allowing access to OTC oral contraceptives is a safe and necessary step that must be taken to ensure that all individuals are able to effectively limit unintended pregnancies, particularly those with limited access to health care options,” said Jack Resneck Jr., MD, president of the American Medical Association in a statement. “We urge the FDA to act swiftly to approve over-the-counter access to oral contraceptives without an age restriction.”
Jay Croft contributed to this report.