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BOLAR DEBARRED FROM PHARMACEUTICAL SALES TO DEFENSE DEPARTMENT

Executive Summary

BOLAR DEBARRED FROM PHARMACEUTICAL SALES TO DEFENSE DEPARTMENT, according to a March 21 memorandum by the department's purchasing branch, the Defense Logistics Agency. Bolar Pharmaceutical, Bolar Inc., former execs Robert Shulman, Jacob Rivers and President Lawrence Raisfeld "are hereby suspended" from supply arrangements, the decision states. "Findings" on which the suspension is based include Bolar's submissions of "false, misleading or inaccurate information to FDA in conjunction with Bolar's ANDAs for nitrofurantoin, triamterene/hydrochlorothiazide and phenytoin sodium," the memo explains. Such submissions raise "serious concerns about the safety and effectiveness of Bolar products and about the business integrity and honesty of Bolar," the document states. Furthermore, the company's "seriously improper" conduct "seriously affects the present responsibility of Bolar to be a government contractor or subcontractor and provides a basis for the suspension of Bolar." The decision follows a March 19 letter from Rep. Dingell (D-Mich.) to the Defense Department in which the congressman expressed "continuing concern about the lack of full cooperation...by Bolar's new management" with Dingell's House Oversight Subcommittee investigation into the generic drug crisis ("The Pink Sheet" March 26, T&G-11). * In justifying the suspension, the Defense Department memo links Bolar's new President Raisfeld with former President Shulman and former Exec VP Rivers. Bolar named Raisfeld, the former treasurer, to replace Shulman -- and decreased Shulman's and Rivers' roles -- in an initial effort to rectify Bolar's tainted image. Bolar's improper acts are "imputed to Messrs. Shulman, Rivers and Raisfeld...because as officers and directors of Bolar, [they] participated in, knew of, or had reason to know of Bolar's conduct," the department said. Therefore, "the imputation of Bolar's seriously improper conduct to Messrs. Shulman, Rivers and Raisfeld provides a cause for their suspension," the memo states. Special Assistant for Contracting Integrity Janet Cook, who signed the document, wrote that "protection of the government's business interests requires the immediate suspension of Bolar, Bolar Inc., and Messrs. Shulman, Rivers and Raisfeld. Effective on March 21, "the suspension is temporary, pending completion of an investigation of Bolar and any legal proceedings that may ensue," the memo states.
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