An advisory panel of the U.S. Food and Drug Administration (FDA) voted to recommend Opill be sold over the counter (OTC) without a prescription. Opill is a hormonal contraceptive pill first approved in 1970. Advisory committees are panels of outside medical experts who advise the FDA on matters related to the specific area they were appointed to. There are numerous advisory panels. In the latest vote, one panel advises on over-the-counter medications. Another panel advises on reproductive health. The combined panel was composed of 17 experts in a 2-day hearing.
…the U.S. Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) voted unanimously 17 to 0, with no abstentions, that the benefits of making Opill®, a progestin-only daily oral contraceptive, available for over-the-counter (OTC) use outweighs the risks. The joint committee’s vote, while not binding, will be considered by the FDA when making its final decision regarding the potential approval of Opill® for OTC use, which is expected later this year.
Advisory panels have no real authority and their votes are nonbinding. However, the FDA usually takes their advice but not always. Unfortunately, politics sometimes gets in the way. The FDA famously overruled an advisory panel in the case of a questionable Alzheimer’s drug. Aduhelm was approved because it was the first new Alzheimer’s drug in many years despite lacking evidence it worked. The following is what I wrote about it at the time:
The FDA appoints outside experts to advisory panels to evaluate the safety and efficacy of new drug applications and advise the agency on approval. Guess what? At the November 2020 advisory committee meeting, of the 11 members on the advisory panel, 10 voted against approving the drug and the 11th pronounced the data questionable. After reviewing the data, an F.D.A. statistician wrote “there is no compelling, substantial evidence of treatment effect or disease slowing.” The side effects seemed pretty wicked too. Approximately, 40% of trial participants who received the highest dose had brain swelling and bleeding.
A decision by the FDA is not expected until this Summer. However, there is an indication the FDA will again overrule its own advisory panels and decline to allow OTC sales of Opill. At the hearing this week the FDA questioned the drug maker’s data. Opill may have been approved for prescription sales more than 50 years ago but the firm is required to illustrate in studies that consumers will understand how to use the medication correctly. For instance, Opill is an older version of hormonal contraceptives. It works best if taken at about the same time every day. It is also contraindicated in breast cancer patients and is less effective in large women with a high body mass index. The maker has to show that these facts are conveyed and understood by all potential consumers. At the hearing, the FDA did not appear convinced.
In contrast, F.D.A. scientists questioned the reliability of company data that was intended to show that consumers would take the pill at roughly the same time every day and comply with directions to abstain from sex or temporarily use other birth control if they missed a dose. The agency seemed especially concerned about whether women with breast cancer or unexplained vaginal bleeding would correctly choose not to take Opill and whether adolescents and people with limited literacy would use it accurately.
The drug agency has never been aggressive about giving consumers control over their own medical care. The federal agency has approved far fewer prescription drugs for OTC use than many other developed countries. At a time when women’s reproductive health is polarized the FDA may take the safe route.
Dr. Pamela Horn, director of an F.D.A. division for nonprescription drugs, said Tuesday that she “cares deeply about women’s health” and would “love to have unambiguous data” to support the application.
But she said there were numerous concerns, concluding that “the evidence for likelihood of effectiveness in the nonprescription setting submitted by the applicant is mixed and has many limitations.”
It makes me wonder if her superiors didn’t order her to give them some cover in case politics makes it difficult to approve. According to the New York Times, presentations made by Opill’s maker gave a vey different viewpoint:
“Despite availability of a variety of contraceptive methods, nearly half of the pregnancies are unintended every year,” Dr. Carolyn Westhoff, an obstetrician-gynecologist at Columbia University’s Mailman School of Public Health, testified. She noted that other over-the-counter methods, such as condoms, were less effective than the pill and added, “We need more effective methods to be available without a prescription.”
Dr. Pamela Goodwin, a breast cancer oncologist at Sinai Health System in Toronto, testified that very few breast cancer patients would be at risk, because their doctors would advise them against using it. The company’s study found that 97 percent of breast cancer patients correctly opted not to take the pill.
As one expert put it, the directions are very simple, take a pill the same time every day. Most women in the study did that. If they failed they took precautions. By contrast, the FDA is famous for taking something simple and trying to make it complicated in the name of patient safety (or is it in the name of bureaucracy?).