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BARR LABS ORDERED TO CEASE DISTRIBUTION OF 24 OF 58 PRODUCTS

Executive Summary

BARR LABS ORDERED TO CEASE DISTRIBUTION OF 24 OF 58 PRODUCTS currently being manufactured and shipped by the firm pending validation of product processes in a Feb. 4 decision by Newark federal court Judge Alfred Wolin. Barr explained Feb. 5 that the products involved in the temporary suspension, "on a full year basis," represent approximately 40% of the company's sales. Barr said it will continue to manufacture and ship 34 products. The 24 products involved in the court-ordered suspension include various strengths and formulations of 12 drugs. Among these are six erythromycin products, two strengths of cephalexin in oral suspension, two cephradine formulations, and two strengths of meclofenamate caps and meperidine tabs. Explaining the need for suspensions, Judge Wolin specifically cited Barr's lack of failure investigations, releasing of batches "on the basis of selective data" and "refusal" to validate cleaning processes. "There can be no dispute that Barr has violated" good manufacturing practices and the FD&C Act, Wolin maintained. "Due to established past violations and the risk of future violations...the court concludes that injunctive relief is necessary to safeguard the public interest." The 80-page decision requires Barr to submit to FDA and the court a proposed schedule of validation within 10 business days and to complete all validation studies within one year. The decision further requires the firm to "produce the data underlying its analytical [methods] validation studies relied upon during the proceeding of this case" within 30 days. Barr said that "well before" Wolin's opinion was issued, "many of the validation studies the judge is requesting on the temporarily suspended products" already had been initiated by the firm. Judge Wolin also ordered Barr to recall 12 lots of eight of the products involved in the suspension. In the case of these lots to be recalled, Wolin agreed with FDA's contention that Barr inappropriately had ignored or invalidated failing test results on the products. The court decision calls for FDA to provide a recommendation regarding "the appropriate recall class for each batch Barr must recall, together with evidence supporting their position" within 10 business days "after which time the Court will issue further instructions on the mechanics of the required recall." Arguments on the case of U.S. v. Barr began in August and were concluded in October ("The Pink Sheet" Oct. 19, 1992, T&G-12). The case involved two suits filed during the spring of 1992: a request for preliminary injunction by FDA against Barr filed by the Justice Department in June seeking the suspension, recall or revamping of various Barr products due to alleged GMP violations; and a suit filed by Barr in April seeking relief from allegedly ad hoc drug regulation by FDA ("The Pink Sheet" June 15, 1992, p. 11). The two suits were combined by Wolin into the current case under the jurisdiction of the Newark, N.J. district court. The compliance problems with FDA led Barr in April to suspend production of a variety of products judged less central to the firm's operations pending resolution of the problems with the agency. Barr says it plans to bring most of those products back into production, along with those products in the court-ordered suspension, as soon as feasible. The suspensions have had an impact on Barr's financial results. Net sales for the six months ended Dec. 31 were $33 mil., down from $60 mil. last year. FDA issued a statement following the decision, declaring that "the court clearly found that Barr violated the FD&C Act by failing to comply with [CGMPs] and might do so again unless it were ordered to comply." FDA expressed support for the court order as being "strongly in the public interest. Compliance with [GMPs] is necessary to ensure the safety and efficacy of drug products," the agency maintained. Barr President Bruce Downey commented that "our job right now is to explain the judge's decision to our customers, correct what the judge believes needs attention, and get back to a productive working relationship with the FDA." Barr indicated that a final decision has not been made on appealing the decision, although the firm's cooperative tone suggests that an appeal will not be forthcoming.
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