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FDA v. BARR TRIAL RESUMES IN NEWARK FEDERAL COURT ON SEPT. 10

Executive Summary

FDA v. BARR TRIAL RESUMES IN NEWARK FEDERAL COURT ON SEPT. 10 with continued cross-examination of FDA field inspector David Mulligan by defense attorney Bruce Downey (Washington, D.C. office of Winston & Strawn). The trial, which began on Aug. 17, had been suspended on Aug. 19 by Judge Alfred Wolin to allow both sides an opportunity to negotiate an out-of-court settlement. However, they could not reach an agreement, and the trial was rescheduled. Indicating some frustration that the case was not settled, Wolin informed attorneys for both sides on Sept. 10 that he has a busy criminal court schedule in September and FDA v. Barr must be squeezed into free time between cases. Consequently, the trial could be protracted. Cross-examination of Mulligan, the first witness, was expected to continue through Sept. 14; both sides have additional witnesses to question. Barr said it plans to summon between 10 and 20 experts who will support the firm's manufacturing procedures. Trying the case on behalf of FDA, Assistant U.S. Attorney Beth Kaswan described Barr as "among the worst violators" of good manufacturing practice regulations (GMPs). FDA is asking the court to demand a halt in the manufacturing of 15 products, improvements in Barr's production methods and process testing for 45 other products. FDA is also seeking the recall of 30 lots of Barr products due to "egregious" GMP violations ("The Pink Sheet" Aug. 24, In Brief). Downey told the court in his opening statement Aug. 17 that "you will not hear in this proceeding...that there is any Barr product in any pharmacy in the U.S. that does not meet the U.S. Pharmacopoeia standards." Mulligan testified that in his experience of conducting about 500 inspections of 40 or 50 different drug manufacturers, he found Barr "the worst in terms of failures and several other areas," such as the number of "product mix-ups" and "lack of failure investigations." He added that "in a number of cases, Barr would conduct an investigation to confirm that the results failed" without finding out "why it failed" and how to "make whatever corrections are necessary so that other lots of the product don't fail again." Judge Wolin indicated during the first day of the trial that he suspected FDA of imposing subjective standards on the company. The judge interrupted Mulligan's testimony at one point Aug. 17 to ask whether a requirement for validating the cleaning of equipment is stipulated in FDA regs. "The reason that I ask the question is, part of the problem here as I view it is that the FDA may be asking Barr to do things that [are] not in the GMPs. I do not know where the truth lies. So when you say [a cleaning validation process is] 'prescribed,' prescribed by Mulligan may not have the full force of law as opposed to prescribed by the [regs] and the GMPs." He later asked: "How am I going to deal with a situation where I have someone who subjectively from the bureaucracy is unreasonable?" One observation in an FDA inspection report cited Barr for testing for content uniformity of a product in a drum rather than in the blender from which it was poured. Mulligan testified that "the pharmaceutical literature" for 20 years and industry literature discuss the weak uniformity that can result in ribbon blenders; consequently, he said, "if you want to best sample your blend, you're going to do it from those areas of weak uniformity." The judge replied: "But as a trier of fact, where there's no code I can look to, there's no USP I can look to, there's no industry standard I can look to, maybe that's a disputed issue and maybe we're going to have to have people come in and testify about blenders and drums and where to look for the mix so that the issue is decided in fairness." Wolin then asked: "Does the literature say blend samples shall not be taken from drums?" The inspector replied: "No, it does not," and if a firm disagrees with FDA's interpretation, "I guess we end up where we are now." The court "has to determine whether or not the literature supports" FDA's interpretation, Wolin observed. On Aug. 19, the first day of cross-examination, Downey produced the Sept. 29, 1978 Federal Register to cite the preamble to the pertinent regulation. The preamble says the reg does not specify that samples ust be taken directly from a blender "so that manufacturers could choose to do potency assays at either phase, but certainly before release for marketing." When the trial resumed Sept. 10, Wolin could devote only about 90 minutes to hear the case. During that time, Downey questioned several judgments made by FDA that Mulligan acknowledged to be errors. At one point, Wolin seemed bemused that FDA lacks the kind of enforcement powers that Congress has tried to authorize this year. After Mulligan complained that Barr "made a significant change" in the manufacturing method and the batch size of propoxyphene with acetaminophen in April 1990 but did not request approval for the change until December 1990, Wolin asked why the agency did not "order a recall." Informed by Mulligan that "FDA doesn't have the authority to order a recall," Wolin commented: "Strange law, that something doesn't comply and you do not have the administrative wherewithal or power to order a recall."
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