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EX-BOLAR REGULATORY AFFAIRS DIRECTOR SUSAN LONG PLEADS GUILTY

Executive Summary

EX-BOLAR REGULATORY AFFAIRS DIRECTOR SUSAN LONG PLEADS GUILTY to making false statements to FDA and to obstructing an agency investigation of the generic drug company, a Feb. 5 press release from Maryland's U.S. Attorney's Office announced. The counts relate to Bolar's substitution of SmithKline's Dyazide (triamterene/hydrochlorothiazide) for its own generic drug during bioequivalence testing. Long "faces maximum penalties of five years incarceration and a $ 250,000 fine on each of the two charges," the release says. The former Bolar exec "has agreed to cooperate with the government in its continuing criminal probe of Bolar's activities." Long is tentatively scheduled to be sentenced on June 14 in Baltimore Federal Court. However, she is unlikely to be sentenced until her cooperation in the investigation of Bolar is complete, the U.S. Attorney's Office said. The sentencing of two other Bolar execs, former R&D director Gena Finelli and former regulatory affairs manager Gloria Schetlick also depends on future charges brought against other Bolar employees. Finelli's sentencing is tentatively set for May 23 and Schetlick's arraignment is tentatively scheduled for April 29. Schetlick has pled guilty to making false statements and obstructing an FDA inspection ("The Pink Sheet" Dec. 17, T&G-7). She was involved in creating and altering documents to cover Bolar's switching of the branded Dyazide for its own product. Finelli was charged with obstructing FDA's inspection of the firm by directing employees to lie to investigators about the existence of notebooks from the R&D lab ("The Pink Sheet" Oct. 22, p. 11). In a Jan. 16 criminal information, Long was charged with one count of causing the submission to FDA investigators of a fabricated R&D raw material report on one lot of triamterene/hydrochlorothiazide for which there was no free sample lot. The second count charges Long with producing fabricated encapsulation records for the lot of triamterene, as well as for four other drugs ("The Pink Sheet" Jan. 21, In Brief). During an inspection of Bolar manufacturing facilities in Copiague, N.Y. from Aug. 21, 1989 to Oct. 18, 1989, FDA investigators were given "copies of various false records referring to the alleged raw material free samples," the release says. The false records also contained "a false encapsulation record" for the triamterene lot. "The senior Bolar officer who had originated the idea of false encapsulation data later expressed concern that encapsulation records were not customarily prepared for Research & Development lots and, therefore, the record prepared for triamterene/hydrochlorothiazide could prompt suspicions by the FDA investigators," the U.S. Attorney's Office said. "Therefore, the officer directed Long to prepare false encapsulation records for lots of clindamycin HC1 150 mg, danazol 200 mg, fenoprofen calcium 200 mg, and tolmetin sodium 400 mg." The records were given to FDA inspectors on Sept. 20, 1989 "by the senior Bolar officer," the release says. During congressional and FDA investigations, Long, at "the direction of senior Bolar officers," was engaged in destroying documents, gathering documents for removal from Bolar's facilities, "misrepresenting her knowledge of Bolar's activities to FDA investigators, and participating in meetings with which obstructive efforts were planned," the release states. Long also submitted false information on Bolar ANDAs to FDA's Division of Generic Drugs, the release adds.
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