FDA Approves First Over-the-Counter Birth Control Pill

THURSDAY, July 13, 2023 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday approved the nation's first over-the-counter birth control pill, a move that will likely pave the way for far greater access to contraception for Americans.

Women will be able to buy the progestin-only oral contraceptive at drug stores, convenience stores, and grocery stores, the FDA said. There is no age limit.

Opill (norgestrel) should be available in stores starting in January or February, The Washington Post reported. The suggested retail price is expected to be announced this fall. Opill was first approved by the FDA in 1973. Other types of birth control pills will remain prescription only.

"Today's approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States," Patrizia Cavazzoni, M.D., director of the FDA Center for Drug Evaluation and Research, said in an agency news release announcing the approval. "When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy."

In its decision, the FDA followed the recommendation of an advisory panel, which voted unanimously in May in favor of the over-the-counter pill. In briefing documents filed before the advisory panel meeting, the agency raised concerns about whether people will use these pills appropriately. Studies showed that a high proportion of consumers understand the Opill label instructions, supporting their ability to properly use the drug over the counter, the FDA has said.

The American Medical Association, American Academy of Family Physicians, American College of Obstetricians and Gynecologists, and other medical organizations already support over-the-counter access to hormonal contraception without age restrictions.

The approval of Opill was granted to Laboratoire HRA Pharma, recently acquired by Perrigo.

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