Adolescent Access Weighs Heavy In US FDA Decision On First OTC Daily Oral Contraceptive

FDA asks its Nonprescription Drug and Obstetrics, Reproductive and Urologic Drugs advisory committees during a joint meeting on 9-10 May to recommend whether to approve HRA Pharma’s proposal for OTC switch of a daily oral contraceptive, its 0.075-mg norgestrel tablet branded Opill.

Sales to adolescents remain a key factor in Food and Drug Administration decisions on allowing OTC sales of reproductive health drugs while literacy levels among participants in an actual use study also claim space in the agency’s consideration of the first US proposal for a nonprescription daily oral contraceptive.

The FDA will ask its Nonprescription Drug and Obstetrics, Reproductive and Urologic Drugs advisory committees during a joint meeting on...