ACCESS Through OTC Innovation Act

This bill changes federal drug law for over-the-counter (OTC) monograph drugs, which are nonprescription drugs sold under set FDA standards. When a company asks the Department of Health and Human Services to issue an order recognizing such a drug as safe and effective, the agency would have to use the least burdensome appropriate means for supporting and reviewing that request. If published reports are not enough, the agency would have to meet with the requestor upon a reasonable written request to recommend what evidence is needed, including possible study design and size. The agency would have to write meeting minutes, share them with the requestor, and add its study recommendations and a meeting summary to the official record. The bill states that it does not change the existing standards for judging whether a request is complete or whether a drug is safe and effective.

Full text and official record on Congress.gov

Sponsors

• Greg Landsman Democrat sponsor
• 0 cosponsors