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Executive Summary

U.S. v. BARR: PRODUCT SAMPLE TESTING FAILURES CITED BY FDA field investigator David Mulligan as one of the reasons the agency is seeking a temporary injunction against the generic drug firm from Newark, N.J. federal court Judge Alfred Wolin. Mulligan discussed sample testing failures uncovered by FDA investigators during inspections of Barr Labs during the last day of cross- examination Oct. 1. Barr Labs defense attorney Bruce Downey (Washington, D.C. office of Winston & Strawn) asked Mulligan why FDA wanted to recall Barr's aspirin with codeine. The FDA inspector replied that the product had failed content uniformity testing because one tablet of the initial 10 tested had failed by a wide margin. "It's the fact that you have the codeine at 64.8%, which is outside the 75%" content uniformity allowance, Mulligan said. The FDAer acknowledged that Barr had conducted tests on an additional 50 tablets, all of which were within specifications. However, he continued, the gross failure of the one tablet indicated a bad lot and made additional tests irrelevant. "And so from your point of view, even if Barr had tested another thousand tablets from this lot [and] all of them were within the 85 to 115 [percent specifications], because of this one would say it couldn't be released. Is that your view?" Downey asked. "Yes," Mulligan replied. Sample testing failures are one point of dispute between FDA and Barr in the trial, which began Aug. 17. FDA is asking the court to order Barr Labs to cease production of 15 of its products, improve its production methods and process testing for 45 other products and recall 30 lots due to alleged problems with current Good Manufacturing Practices regulations. Barr challenged FDA claims of GMP violations that were not observed during inspections but were cited in the period since the agency filed suit against the company. Mulligan said during cross-examination that "since the second inspection" by FDA investigators last February-March, "we've received a lot of material in the litigation process...which has shown to us that the failure investigations have not included all systems, all situations." The FDAer told the court that a "graphic example would be the meclofenamate lots, where as much as two-fifths of a lot failed weight variation or were rejected, and there was no failure investigation at all." The trial concluded on Oct. 12, four days before scheduled. A decision in the trial is expected by mid-November. Judge Wolin, who has been trying to accelerate the pace of the trial due to a heavy autumn court schedule, informed both sides on Oct. 9 that he had heard enough testimony and gave Barr one final day to call additional witnesses. Barr was told to submit its affidavits on Oct. 14; the government must respond to those affidavits within one week. Final papers are due Oct. 23.

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