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http://www.nytimes.com/2002/06/20/business/20PHAR.html

U.S. Is Investigating Schering on Ingredients Used in Drug

By MELODY PETERSEN

he United States attorney's office in Newark is investigating how the Schering-Plough Corporation manufactured one or more prescription drug products, the company said yesterday.

The company, which makes the popular allergy medications Claritin and Clarinex, issued a news release last night after The Star-Ledger of Newark reported that federal investigators in New Jersey had begun an inquiry into whether Schering-Plough had used imported, relatively inexpensive chemical ingredients not approved for use in the United States in its products.

Robert J. Consalvo, a spokesman for Schering-Plough, said last night that the company had learned yesterday that the investigation reported by The Star-Ledger was the same as an investigation that the company had already disclosed.

The company said last month that the Food and Drug Administration's Office of Criminal Investigation was conducting an inquiry into its manufacturing in Puerto Rico, where Schering-Plough has two large factories. That investigation, Mr. Consalvo said, is now being handled by federal officials in New Jersey. He did not elaborate.

Mr. Consalvo said the company did not know specifically what the federal investigators were looking at except that the inquiry appeared to involve products made in Puerto Rico.

"We're confident that all our pharmaceutical products in the marketplace are safe and effective," he said.

Last month, Schering-Plough agreed to pay $500 million to the federal government because of its repeated failure over the years to fix problems in manufacturing dozens of drugs at four factories, in New Jersey and Puerto Rico.

Michael Drewniak, a spokesman for the United States attorney's office in Newark, declined to comment.

Pharmaceutical companies often buy chemical ingredients made by foreign suppliers. F.D.A. approval is needed for a chemical supplier that makes ingredients for prescription drugs sold in the United States.

Sidney Wolfe, the director of a Public Citizen health research group, said he had been interviewed by a lawyer for the United States attorney's office in New Jersey and an official from the F.D.A.'s Office of Criminal Investigation last fall about information Dr. Wolfe had about some patients who had died after using asthma inhalers that the company later recalled. The company has said it has no indication the inquiry involves inhalers.

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