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GENERIC WHISTLEBLOWERS DID NOT FACE FDA RETALIATION

Executive Summary

GENERIC WHISTLEBLOWERS DID NOT FACE FDA RETALIATION, is the conclusion of a three-person panel of outside consultants picked by the agency to review allegations of FDA retaliation against generic drug firms that blew the whistle on industry and FDA during the generic drug investigations. "Retaliation towards a single company is not evident from any data or information which was collected," panel member John Zarembo, PhD, stated in the report. In a May 3 "Talk Paper," FDA announced the panel's conclusion "that there was no evidence that FDA employees engaged in activities that could be considered unfair, retaliatory, or inapproriately directed toward any particular firm or manufacturer." Although the investigation failed to uncover evidence of FDA retaliation, the consultants point out several instances where the agency acted in an arbitrary or sloppy manner when making regulatory decisions or handling documents. The report, submitted to FDA April 30, was written by Zarembo, a private consultant in pharmaceutical chemistry; American Pharmaceutical Association Senior Director of Pharmacy Affairs Arthur Kibbe, PhD; and James Kopf, an inspector in HHS' Office of the Inspector General. The trio was appointed in September 1990 by then FDA Acting Commissioner James Benson ("The Pink Sheet" Oct. 1, T&G-1). The consultants focused their investigation on the history of Barr and Mylan, because of those companies' repeated claims that they were and continue to be victims of agency retaliatory actions, and on Cord and Danbury, because of the firms' volume of ANDA activities and lack of retaliation allegations. The report notes that Danbury "declined to cooperate with the consultants." To accomplish their mandate, the consultants reviewed agency documents and correspondence, interviewed FDA and industry employees, compared ANDA review times, and reviewed the frequency of FDA inspections. Each consultants' analysis and views are provided as separate reports. The panel looked into Barr Labs' allegation that it had been placed on an inspection list by FDA because the firm testified about alleged unfair treatment by FDA's Generic Drug Division at Rep. Dingell's (D-Mich.) May 11, 1989 House Energy & Commerce/Oversight subcommittee hearing, the first hearing that focused exclusively on particular companies' regulatory approval experiences. On the same day, FDA began an inspection of Barr's Pomona, N.Y. facility. "Barr was not added as a direct retaliation on part of any individual or the agency for having testified before Congress," Kibbe concluded. Reviewing the occurrences at an FDA meeting regarding the inspection list, Kibbe determined: "I do not believe any in attendance knew of the hearings content or the witness list. I do believe that the addition was in part due to a reaction to the overall generic drug investigations and a feeling that it would be best to err on the side of inclusion rather than exclusion." Data gathered by the consultants on the number of inspections conducted at Mylan, Barr, Danbury and Cord for fiscal 1987 through FY 1990 show that Mylan was inspected 16 times, Barr 12 times, Cord had nine inspections, and Danbury had eight inspections. "Based on this comparison, the company with the most deficiencies per inspection was inspected the least amount of time," Kopf said. He added that "though it is not believed that deliberate retaliation was the motive in the inspection process, the FDA has done little to dispel the perception given to Mylan and Barr." In fact, as recently as April 16, Mylan Chairman Roy McKnight was repeating the retaliation story, saying his company has been inspected 30 times since its appearance before the May 1989 Dingell hearing. McKnight told a generic drug analysts conference that FDA is trying to "nail" Mylan ("The Pink Sheet" April 22, p. 7). He also asserted that the slow ANDA approval rate for Mylan products is proof of FDA's motives. However, the consultants determined that Barr and Mylan were not retaliated against in terms of the number of ANDAs approved and review times. "The number of ANDA approvals in the last two years is not a matter of retaliation against certain companies, but a result of retaliation against the previous system and its directors," Kopf stated. The panel also investigated Barr's allegation that FDA's denial of its conjugated estrogens ANDAs and the related changing of bioequivalence testing requirements for such products was unfair and unnecessary. Kibbe concluded that "the agency had the duty to examine substantive information and to correct original mistakes if those corrections are necessary to protect the public health." The consultants also concluded that the temporary misplacement of documents submitted by firms on their conjugated estrogens products was not intentional on the part of the agency. In reviewing pending and approved ANDAs, the consultants were able to confirm Cord's claim that one chemistry reviewer has not yet approved any of Cord's ANDAs. "The system allows for individual chemists to have extraordinary power over the success or failure of an individual company and promote arrogance in some individuals," Kibbe stated.
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