FDA Considering Use Of Foreign Marketing Data For OTC Review

Industry comments are being sought by the US Food and Drug Administration on a possible proposed rule that would set eligibility requirements for material time/extent marketing under the OTC Review to allow over-the-counter conditions into the monograph system. Most importantly, according to the US Non-prescription Drug Manufacturers Association, the agency is considering whether to allow use of foreign marketing data to satisfy material time/extent marketing.

The FDA's Advanced Notice of Proposed Rulemaking published last month also addresses a two-step application procedure for companies interested in seeking a new monograph condition; declares the FDA's intent to propose a rule to require US Pharmacopeia chemical standards for monographed ingredients; and describes the marketing policy the agency is considering for these new OTC drug conditions, the NDMA reports.

Agency Emphasis On Assistance Meantime, speaking at the NDMA's 28th annual Manufacturing Controls Seminar last month, FDA deputy commissioner for external affairs Sharon Smith Holston told attendees that the agency has shifted its emphasis from "enforcement to assistance, from censure to communication and consultation."