FDA advisors recommend sale of over-the-counter birth control pill

A Food and Drug Administration advisory panel on Wednesday endorsed selling what could be the first birth control pill to be available without a prescription.

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The panel, which included the Nonprescription Drugs Advisory Committee and the Reproductive and Urologic Drugs Advisory Committee, unanimously voted to recommend selling Perrigo’s Opill over the counter.

“The evidence demonstrates that the benefits clearly exceed the risks,” Dr. Kathryn Curtis, a panel member and health scientist in the Centers for Disease Control and Prevention’s Division of Reproductive Health, said during Wednesday’s meeting. She cited increased taxes, a reduction in unintended pregnancies and more equitable access to contraceptives.

“With respect to risks, for safety, safety was established 50 years ago when the original approval was made and the accumulating body of evidence since then have shown that these pills are safe with very few counter-indications and long-term safety concerns,” she said.

Officials with the FDA raised concerns over the risk of breast cancer or progestin-sensitive cancers and vaginal bleeding without any known causes with use of the pill, Reuters reported. Authorities noted that the risks “are different from risks associated with currently available nonprescription contraceptive methods.”

However, the panel mostly dismissed those concerns, saying that the benefits for people who don’t currently have access to birth control carried more weight.

“Overall, I do think as a risk-communication situation the benefits outweigh the risks, and that’s why I voted yes,” Dr. Cynthia Baur, director of the Horowitz Center for Health Literacy, said Wednesday. She urged regulators to ask sponsors to continue to bring in better data about how well people understand the proper way to use the medications in question.

Perrigo last year asked the FDA to make Opill available over the counter. The progestin-only daily birth control pill was first approved by the FDA for prescription use in the U.S. in 1973.

A final FDA decision is expected this summer, The Associated Press reported.

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