FDA Panel Supports Rx

The Food and Drug Administration's (FDA) Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee voted 17 to 0, with no abstentions, that the benefits of making Opill®, a progestin-only daily oral birth control pill, available for over-the-counter (OTC) use outweighs the risks.

Opill contains 0.075mg of norgestrel, a single active steroid ingredient. According to scientific evidence, progestin-only pills like Opill have been shown to be effective for the prevention of pregnancy and are safe for most women to use.

The OTC development program included several label comprehension studies, including the ACCESS trial (ClinicalTrials.gov Identifier: NCT04112095), which assessed whether consumers select and use Opill for contraception in a manner consistent with the OTC package directions in an OTC-like setting. The data package also included a pregnancy impact model, which suggested that the availability of an OTC progestin-only pill would lead to clinically meaningful reductions in unintended pregnancies in the US.

While the panel did vote unanimously in favor of OTC availability, issues related to adherence and appropriate use in adolescents and individuals with limited literacy were noted. There were also concerns over whether women would be able to correctly self-identify if they were not eligible to use the product (eg, current or past history of breast cancer, vaginal bleeding of undiagnosed etiology).

Although not bound by the committees’ recommendations, the FDA does take them into consideration when making final decisions on approval. Medical organizations, such as the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians have all expressed support of OTC access for oral hormonal contraceptives.