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BARR LABS' SEPTEMBER INSPECTION REPORTS CITE GMP VIOLATIONS

Executive Summary

BARR LABS' SEPTEMBER INSPECTION REPORTS CITE GMP VIOLATIONS only and do not implicate the company in fraud or misrepresentation of data, Barr declared in an Oct. 24 press release. The firm reported that its Northvale, N.J and Pomona, N.Y. manufacturing facilities were subject to FDA inspections from April to September. "The inspectors' reports (Form 483) raised several CGMP [current good manufacturing practices] issues," Barr said. The agency, however, "uncovered no incidence of fraud, misrepresentation, deception or other similar unlawful acts," Barr said. The 483s were issued at the end of September. Barr said it responded to the 483s within 10 days and then met with representatives from FDA's field offices in Brooklyn, N.Y. and West Orange, N.J. to "reassure the agency of Barr's continued commitment to manufacturing quality generic pharmaceutical products." Barr said it "is confident that its responses fully addressed all of the agency's concerns" and that "FDA is currently reviewing Barr's responses." Reportedly, FDA has threatened to seek an injunction against Barr if the company does not comply with GMPs. Barr characterized "many" of the observations in the inspection reports as "trivial in nature" and suggested that they "could be considered subjective and retaliatory." The press release adds that "certain observers also believe that Barr has been systematically retaliated against by the FDA for being one of the whistleblowers during the recent generic drug scandal and for questioning dubious scientific and administrative decisions made by the FDA." Among observations on the 483s that Barr said it considers "trivial" are a citation for a misidentified lot number of methotrexate that was recorded as OJ572GF instead of OG572GF. The company noted that it was also cited for "reworking" products which Barr contends were continually mixed in accordance with an approved ANDA. Another citation was for inadequate training of employees, Barr said. The company maintains that its staff, including 73 full-time chemists, have more outside training than any other generic firm and that Barr is "totally dedicated" to high quality performance. The company indicated that it may draft a letter to members of Congress to discuss FDA's handling of Barr as well as overall problems in the Office of Generic Drugs. Prominent among Barr's complaints will be what it perceives to be the Office of Generic Drug's slow movement on its generic AZT application. Barr filed an ANDA on March 19 for a generic zidovudine and announced it was challenging Burroughs-Wellcome's patent on the AIDS drug ("The Pink Sheet" April 23, T&G-4). The company believes that approval of its ANDA would strengthen its position in the challenge. FDA reportedly expects to complete the first review cycle on AZT close to the 180-day statutory limit. The office reportedly considers the drug a candidate for expedited approval under the "blockbuster" policy it is putting into place. Barr has performed one recall as a result of the inspections, the company said. The company initiated a recall of allopurinol 300 mg tablets that failed dissolution testing in the last month before expiration. The company said it expects that little if any of the product covered by the recall is still on the market.
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