Officials of two generic drug manufacturers pleaded guilty in U.S. District Court in Baltimore yesterday to charges of falsifying records submitted to the U.S. Food and Drug Administration while seeking approval for new drugs.
Kumar S. Prasad, 53, manager of research and development at Chicago-based Pharmaceutical Basics Inc., pleaded guilty before Judge John R. Hargrove to making false statements to the FDA's generic drug division in 1987.
The company sought approval for the product Timolol Maleate, which is used to treat hypertension, migraine headaches and heart attacks. It is a generic substitute for Blocadren, which is made by Merck Sharp and Dohme.
Statements submitted to the FDA misrepresented the number of capsules and tablets produced in the company's drug tests.
Assistant U.S. Attorney Gary P. Jordan said the company tried to cut costs by making the smaller batch size. He said the small-batch tests carried a danger of being unreliable when the company tried to duplicate the blend with a larger sample.
Prasad will be sentenced Sept. 15.
In the other case, Arnold S. Mendell, 47, director of quality assurance at Bolar Pharmaceutical Co., pleaded guilty to filing fabricated batch production records for the drug Phenytoin Sodium, an anti-convulsive medication, and to obstruction charges.
Mendell admitted to helping the company maintain two sets of records -- one kept for company use that contained actual formulas, the other submitted to the FDA that concealed deviations.
Federal investigators said Bolar earned millions from products sold as a result of FDA approvals based on false records.