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Executive Summary

FDA top managers are preparing for Round 2 before Rep. Dingell's (D-Mich.) House Energy & Commerce/Oversight Subcommittee. A followup hearing to focus on the agency's handling of the generic drug industry is tentatively set for Nov. 17. The mid-November hearing is contingent on the progress of the Clean Air Act amendments, which are scheduled to be marked up by the full committee, also chaired by Dingell. If FDA is called to testify in mid-November, it will be the second time for Com. Young before the subcommittee on the generic regulation issue. Young first testified on the generics situation, along with other FDAers, on July 11. FDA investigators have testified subsequently, but the committee took a different attitude toward them than toward the agency management. Dingell called the investigators part of the solution, not part of the problem ("The Pink Sheet" Sept. 18, p. 13). In the intervening two months, FDA has been actively reviewing the generic industry, and the agency could be in a better position to answer Dingell's inquiries. In an Oct. 13 internal memorandum, Young requested the rapid completion of FDA's activities in the generic drug area. "Prior to the hearing," Young noted, "I would like to complete actions on as many projects and initiatives as possible to further demonstrate FDA's commitment to swiftly resolving the generic drug situation." The memo specifically refers to the "management implementation plan" that is being developed in response to the HHS Inspector General's audit report on the ANDA approval process. The HHS Inspector General's office expects to receive the plan during the week of Oct. 23. Young pointed out that the wrap-up of FDA's analysis of the top 30 generic drugs, is scheduled to be ready by Oct. 31. FDA's for-cause inspections of 13 generic firms and the inspections of 20 additional companies are "to be completed by early November," the memo says. So far, a number of generic firms have received relatively clean bills of health, with inspection reports citing minor deviations from good manufacturing practice (GMP) regulations ("The Pink Sheet" Oct. 16, p. 3). Mylan, for example, is currently being inspected by FDA as one of the 20 largest generic firms. The company said that it has been "found to be absolutely clean." Mylan precipitated the generic drug investigation when it provided evidence to Dingell's subcommittee of irregularities involving FDA's review of ANDAs. The firm testified at the subcommittee's May 11 hearing that its ANDA approvals were deliberately being held up by FDA reviewers. Copley Pharmaceutical, a Canton, Mass.-based generic firm was inspected by FDA from Aug. 22 to Sept. 8. Five district inspectors reviewed Copley's ANDAs: procainamide HCl tabs, potassium chloride extended release tabs, thiothixene oral solution, thioridazine HCl oral solution, and betamethasone dipropionate lotion. FDA's review of the ANDAs found everything "in order," Copley said. Although FDA did not find any problems with the five ANDAs, it did issue a form FD-483 list of adverse observations that cites 14 minor GMP deviations. Those GMP problems already have been corrected, most of them during the inspection, Copley said. The FD-483 was issued on Sept. 11 and Copley responded to the report on Sept. 18. FDA conducted an inspection of Lemmon Company from Aug. 24 through Sept. 19. Inspectors did not find any ANDA problems, Lemmon said. FDA reviewed at least three ANDAs including doxycycline hyclate and indomethacin. Lemmon also received a FD-483 that lists GMP violations. The company says that it is correcting the problems.

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