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

by Medindia Content Team on February 4, 2006 at 1:55 PM
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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.

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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.
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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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