NAPM on user fees

Executive Summary

The National Association of Pharmaceutical Manufacturers submitted comments to the Administrative Conference April 13 objecting to FDA's proposal for user fees. The association objected to FDA's proposal to have one set fee for NDAs and, although a fee was not proposed for ANDAs, questioned the equity of previous fee proposals for ANDAs. NAPM suggested that user fee programs should be centralized, "perhaps in OMB, where necessary expertise, if not already present, can be developed and applied to all agencies".