OTC Daily Oral Contraceptive Proposal In US Packs Promise Of Access, But Peril Of Single Option

Discussion of whether progestin-only formulation will be approved for OTC sales and succeed in the US nonprescription market perhaps has been overshadowed by expectations of political pressures affecting FDA’s evaluation and decision after HRA submitted its NDA.

Discussion emerged soon after a proposal for the first OTC daily oral contraceptive in the US was announced on whether approval would swing on influences other than the drug’s safety and efficacy for use without the intervention of a medical professional.

Prevalent in the discussion are mentions of HRA Pharma’s new drug application for OTC 0.075-mg norgestrel emerging soon after a...