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Executive Summary

FDA's recently initiated program to monitor bulk pharmaceutical quality is up and running, FDA Division of Generic Drugs Director Marvin Seife, MD, told a Regulatory Affairs Professional Society educational workshop in Morristown, N.J., on Aug. 7. "We went out [to the Bureau of Drug Analysis in St. Louis] last April to see if we could develop a program on bulk pharmaceuticals," Seife explained. "We know that companies, when they first submit an ANDA, give us top of the line for bulk pharmaceuticals, and we expect good results. It's when our people pick this stuff up at the docks 10, 12 months, two years, three years from now that we'll start finding all sorts of imperfections." Seife noted that the division now receives monthly computer-generated reports from the Bureau of Drug Analysis of completed ANDA drugs that include sample history and analytical results. "It's the first time, to the best of my knowledge, in the 20 years at the agency that a program 1ike this has started and been carried out." Seife declared. He noted that the operation has been computerized by FDA's Compliance Office. The Bureau of Drug Analysis has "the facilities and is capable of doing it," Seife added. "We think for the first time, over the next few years, we will get a handle on bulk pharmaceuticals." Approximately 650 Post-1962 ANDAs Submitted To Agency Since Enactment of Waxman/Hatch Commenting on the flood of ANDAs submitted to the generic drug division since the Waxman/Hatch law want into effect, Seife noted that approximately 835 post-1962 and pre-1962 ANDAs have been submitted since November. "In addition to the approximate 200 'paper' NDAs transferred to us beginning in March 1984 and our usual influx of approximately 45 original ANDAs and Form 6's per month received prior to November 26, 1984," Seife said, "we have received 650 post-1962 ANDAs and approximately 185 pre-1962 ANDAs since the Act of 1984 became effective." Seife reported that the pending applications came from 93 different firms, with four firms having "more than thirty applications being reviewed or awaiting review." Only 29 firms had one pending ANDA. Seife pointed out that the division has "continued to approve an average of 32 ANDAs per month, or three every two working days." In addition, the division currently has a backlog of approximately 90 ANDA suitability petitions, Division of Generic Drugs Review Support Branch Chief David Rosen said. "We were surprised at the number of ANDA suitability petitions that we received right in the beginning," Rosen said. "We have some 90 pending at this point in time from a large variety of products from many different companies." He noted that the division has "gotten out a substantial number" of petitions since June. "We do have a number of issues pending that we feel that once we get a determination on the more difficult issues, we will be able to respond in an expeditious manner," Rosen said. "We are trying to meet the 90 day statutory response time. . .It's been very difficult but we are diligently working to meet that time frame." Rosen asserted that the agency has no ANDAs awaiting FDA review over the 180 day statutory limit. Rosen also noted that the proposed regulations incorporating the provisions of the Drug Price Competition and Patent Term Restoration Act applying to ANDAs "will be published in the Federal Register in the near future."

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