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A brush with the U.S. Regulators can cost a fortune

The Food and Drug Administration held a meeting with Boston Scientific to talk about the repairs in the quality control problems.

A similar meeting was held in 2001 with Schering-Plough // about problems with its manufacture of asthma inhalers.

But the company failed to make any amendments. This provoked the FDA to withhold approval of Clarinex, a blockbuster allergy drug.

To solve this problem Raul E. Cesan, the company's president and chief operating officer with his executive team flew to Puerto Rico for a meeting with F.D.A. inspectors and officials.

The executives said that the meeting was very tense and Mr. Cesan was known for his autocratic style. One of the executives said that after a week there were FDA inspectors crawling in all the plants.

They found more problems and the approval of the drug Clarinex was delayed by more than a year.

The company also paid a fine of about $500 million. Mr. Cesan left the company in 2001 and has since founded an investment partnership. He is also a director of The New York Times Company.

In case of Boston Scientific if F.D.A. officials detect any defiance, the company could be in trouble.

Daniel E. Troy, a Washington lawyer who is a former F.D.A. general counsel said that in times of overall management failures the company has to show some efforts to repair the quality-control problems that were detailed in the agency's warning letter.

A lot depends upon how the company takes action and necessity changes.


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