FDA Panel Makes Big Move on OTC Birth Control Pill

If FDA gives full approval, it could be sold later this year
By Newser Editors and Wire Services
Posted May 11, 2023 12:00 AM CDT
Birth Control Pill Could Be Available OTC This Year
FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. Federal health advisers said Wednesday, May 10, 2023, that a decades-old birth control pill should be sold without a prescription, paving the way for a likely U.S. approval of the first over-the-counter...   (AP Photo/Andrew Harnik, File)

Federal health advisers said Wednesday that a decades-old birth control pill should be sold without a prescription, paving the way for a likely US approval of the first over-the-counter contraceptive medication, the AP reports. The panel of FDA advisers voted unanimously in favor of drugmaker Perrigo's request to sell its once-a-day medication on store shelves alongside eye drops and allergy pills. The recommendation came at the close of a two-day meeting focused on whether women could safely and effectively take the pill without professional supervision. A final FDA decision is expected this summer. If the agency follows the nonbinding recommendation, Perrigo’s drug, Opill, would become the first contraceptive pill to be moved out from behind the pharmacy counter. The company said sales could begin late this year if OK'd.

The New York Times offers a primer on the drug, known as a "mini pill" that contains just progestin, a synthetic version of the hormone progesterone, which thickens cervical mucus to make it more difficult for sperm to get into the uterus. Most current birth control pills contain both progestin and estrogen; progestin-only pills typically have fewer side effects and health risks, but can be less effective if not taken consistently. If the 28 pills per pack are taken at about the same time each day with no break taken between packs, the failure rate is around 7%, or more effective than the current OTC birth control options including condoms and spermicides. Among the other points made in the Times' explainer: The cost of the drug is not yet clear. (More birth control stories.)

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