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Executive Summary

FDA's PRE-APPROVAL INSPECTION TURNDOWN RATE HAS RISEN FOR NDA/ANDAs during the past six months to nearly one in two, according to data recently compiled by FDA field office management. Of 303 NDA/ANDAs and supplemental applications that underwent pre-approval inspections from March through August, 148 (48%) received recommendations to withhold approval from the district offices. By comparison, only 36% of applications audited during the previous year (March 1991 through February 1992) received a turndown recommendation. The most recent data reverses a positive trend in the 1991 data from a year earlier. During the first year that the current pre-approval field review procedures were in place (March 1990 through February 1991), district offices recommended approval delays for about two-thirds (65%) of NDAs/ANDAs following inspections. The decline in adverse audit findings during the second year of the inspection program had been highlighted by FDA field and compliance officials as an indication that industry product development procedures, applications and related manufacturing and control practices were improving ("The Pink Sheet" Feb. 10, T&G-12). The new data on FDA's pre-approval inspection program was presented by Mid-Atlantic Region Assistant Director Joseph Phillips at a workshop on the program cosponsored by the National Association of Pharmaceutical Manufacturers (NAPM) and the National Pharmaceutical Alliance (NPA). Phillips reported that, during the past six months, district offices conducted an inspection for 70% of all applications which they were asked by the Center for Drug Evaluation and Research (CDER) to evaluate. As a percentage of total evaluations, turndowns were recommended for 41% of NDAs and 54% of ANDAs, compared to 37% and 47%, respectively, during the previous year. Supplements, which account for about one-quarter of the applications reviewed by the field offices in the recent six-month period, fared relatively better than full NDAs and ANDAs; only 28% were recommended for turndown. Removing supplements from the data, approval withholdings were recommended for more than half (51%) of NDAs and 59% of ANDAs, based on a compliance status review by the FDA district offices. The recent problems firms have had in passing FDA field audits may reflect, in part, the increased participation of laboratory chemists and microbiologists during the inspections and the more thorough reviews of drug manufacturing facilities and applications, particularly in the lab area. The NDA/ANDA inspection clearance problems, in turn, coincide with the overall increase in FDA enforcement activity in the area of current good manufacturing practice regulations (GMPs). In evaluating the recent six-month data, Phillips reported, FDA determined that a finding of "numerous GMP problems" was the leading reason for the district office recommending NDA/ANDA turndowns -- accounting for 54, or about 10% of those turndowns. A finding of plants not capable or ready to perform as indicated on the application was the primary reason for 41 approval delay recommendations. In 26 cases, regulatory actions were pending against the applicant or a listed supplier, and 21 other turndowns reflected firms implicated in fraud. Findings of significant problems in the areas of product development (16), test methods (14) and stability (13) were other frequent causes for turndowns.

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