May 10, 2023 – FDA advisers today made major progress toward approving the nation’s first over-the-counter contraception pill, voting unanimously that expanding the pill’s availability would do more good than harm.
The FDA approval of the oral contraceptive Opill – a 0.075 mg each day tablet, also called “Mini pills” since it incorporates only the hormone progestin (fairly than a mixture of progestin and estrogen) – could occur as early as this summer. Although the agency just isn’t certain by the advisory panel's recommendations, a 17-0 vote would give the pill serious confidence.
HRA Pharma, the French pharmaceutical company that makes Opill, is looking on the FDA to approve the drug for all women of childbearing age, including teenagers.
The biggest concern for some members of the advisory committee was how making the pill available over-the-counter would affect certain vulnerable populations, including young people and other people with limited literacy skills. Questions were repeatedly raised about whether the general public would have the ability to know and follow the directions for the drug.
Annie Frisse, MD, MPH, an ob-gyn and assistant professor at Mount Sinai Hospital in New York, says focusing an excessive amount of on this potential problem is doing patients across the country a disservice.
“We expect our patients to be able to read the label for any type of medication and take the medication correctly,” Frisse said. “Tylenol, for example, can be extremely dangerous if taken incorrectly, but we trust our patients to take it correctly and not overdose or harm themselves with these pills.”
And with a contraceptive that has been proven to be as secure because the progestin-only pill, the expectation isn’t any different. With any such contraception, sticking to the dosing schedule (taking it once a day at the identical time) is crucial to effectiveness, because the “window for missed pills” is smaller than with the mixture pills that contain estrogen.
But as Dr. Elise Berlan, an FDA committee member and pediatrician at Nationwide Children's Hospital in Columbus, Ohio, noted, adherence to treatment is “highly imperfect,” even for pharmaceuticals.
“Adolescents can be consistent with daily contraceptive use… Inconsistent daily use likely compromises effectiveness but is less likely to cause greater harm than nonuse,” Berlan said.
Other concerns revolved around breast cancer patients or those with a history of the disease, noting that some women will not be aware that they Birth control pills in the event that they fall into one among these categories. However, FDA advisers stressed that many ladies are aware of this precaution and adjust their use accordingly.
According to a study conducted by HRA Pharma, abnormal vaginal bleeding and menstrual irregularities were probably the most common unintended effects related to consistent use of Opill, occurring in not more than 5% of users each.
The FDA's final decision is high stakes because it will come nearly a 12 months after the overturning of Roe v. Wade, which previously guaranteed a girl's constitutional right to an abortion.
“During this turbulent time for reproductive health in the United States, opening up access to over-the-counter oral contraceptives is a safe and necessary step that must be taken to ensure that all people can effectively prevent unintended pregnancy, especially those with limited access to health care options,” said Jack Resneck Jr., MD, president of the American Medical Association in a press release. “We urge the FDA to act swiftly and authorize over-the-counter access to oral contraceptives with no age restrictions.”
Jay Croft contributed to this report.