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U.S. Bars Generic Drug Imports

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The Associated Press

Published: September 17, 2008

WASHINGTON - The government closed U.S. borders Tuesday to more than 30 generic drugs, including popular antibiotics and cholesterol medicines, made by India's biggest pharmaceutical company, citing poor quality in two of its factories.

The Food and Drug Administration's move doesn't end U.S. sales by Ranbaxy Laboratories Ltd. Instead, it blocks imports of generic drugs, including generic versions of the antibiotic Cipro and cholesterol pill Zocor, as well as pharmaceutical ingredients made at two suspect plants in India.
FDA inspections this year found violations that could lead to contamination, allergic reactions and other problems, and the company hasn't taken proper steps to correct them, said Deborah Autor, director of the FDA's compliance office.

Also, the FDA said it won't approve new products for sale by Ranbaxy until the manufacturing violations are corrected.

India has become one of the world's leading suppliers of generic drugs, and concern about Ranbaxy has been growing since FDA inspectors uncovered quality problems at one of its factories in 2006.

Yet the FDA told consumers who have Ranbaxy products not to worry or quit using them: Repeated testing hasn't found contaminated products, just the threat of them if factory conditions don't improve.

Also, it would be hard for a patient to tell whether drugs were made at the suspect factories or at one of Ranbaxy's other factories in 11 countries.

"We have seen no evidence of harm to consumers from drugs produced at these two facilities and have no reason to believe that drugs already in the U.S. from these plants pose a safety problem," said FDA deputy drug director Douglas Throckmorton.

Among the blocked drugs: the antibiotics ciprofloxacin and clarithromycin; the antiviral acyclovir; cholesterol-lowering simvastatin and pravastatin; and the diabetes drug metformin.

A call to Ranbaxy's U.S. headquarters was not immediately returned Tuesday.

The move also could affect a U.S. program that funds AIDS drugs for Africa.

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