An article in one edition of The Evening Sun yesterday erroneously attributed to a federal prosecutor a statement that both Perkal and PharmaKinetics would plead guilty to the charges. The Evening Sun regrets the error.
Federal prosecutors today charged Baltimore-based PharmaKinetics Laboratories Inc. and Mark B. Perkal, its former executive vice president, with obstructing a U.S. Food and Drug Administration investigation of a generic drug maker.
The charges are contained in criminal information documents filed in U.S. District Court in Baltimore. Prosecutor Gary P. Jordan said both defendants have agreed to plead guilty.
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The documents allege that Bolar Pharmaceutical Co. substituted Dyazide, a name-brand hypertension drug, for its own generic substitute, Triamterene/Hydrochlorothiazide, in FDA-required bioequivalency tests conducted by PharmaKinetics in 1987. The product-switching was done to ensure that Bolar could obtain FDA approval to sell the popular Triamterene capsules, which generated $140 million in sales over the next three years.
When Bolar officials told Perkal of the substitution last June, he allegedly allowed them to replace Dyazide with Triamterene in "retained samples" that the FDA required PharmaKinetics to keep as a backup to support the test results.
Perkal, who served as PharmaKinetics' chief scientific officer, also failed to report Bolar's drug-switching scheme to FDA investigators who were probing the generic drug industry, the documents said.
U.S. Attorney Richard D. Bennett said today's charges end the federal investigation of PharmaKinetics that began last summer. No other company employees have been implicated in criminal conduct, he said.
Bolar and three of its former officers have been convicted of criminal charges for orchestrating the product-switching scheme. Bolar recently agreed to pay a $10 million fine and withdraw is FDA approvals of more than 150 generic drugs.