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PDUFA funds sought for postmarketing reviews, Public Citizen's Wolfe testifies at Senate hearing.

Executive Summary

USER FEE FUNDING OF POSTMARKETING REVIEWS SOUGHT BY PUBLIC CITIZEN's Health Research Group to address the growing workload at FDA's Division of Drug Marketing, Advertising & Communications, according to the testimony of HRG Director Sidney Wolfe, MD, at an April 11 hearing of the Senate Labor & Human Resources Committee. Wolfe noted that the number of drug launch campaigns jumped from 118 in FY 1993 to over 300 in FY 1996. During that same interval, the number of notice of violation letters issued by DDMAC dropped from 247 to 137. Wolfe attributed the decline in NOV letters to a static staffing level at DDMAC.

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