FDA Operation Reveals Many Drugs Promoted as
December 16, 2005 -- An FDA operation found that nearly half of the imported drugs FDA intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with "Canadian" pharmacies. Of the drugs being promoted as "Canadian," based on accompanying documentation, 85 percent actually came from 27 countries around the globe. A number of these products also were found to be counterfeit.
"This operation suggests that drugs ordered from so-called Canadian' Internet sites are not drugs of known safety and efficacy," said Dr. Andrew von Eschenbach, Acting FDA Commissioner. "These results make clear there are Internet sites that claim to be "Canadian" that, in fact, are peddling drugs of dubious origin, safety, and efficacy. We believe that these bait and switch' tactics-offering patients one thing and then giving them something else- are misleading to patients and potentially harmful to the public health."
FDA conducted its operation, named "Operation Bait and Switch," over a few days in August 2005 at JFK Airport in New York City, Miami International Airport, and Los Angeles International Airport. FDA examined all mail parcels suspected of containing pharmaceuticals sent from four countries-India, Israel, Costa Rica, and Vanuatu-that FDA had previously noticed were sources of drugs apparently ordered from pharmacies alleged to be Canadian in origin. Out of nearly 4,000 parcels examined, almost 1,700 or about 43 percent had been ordered from "Canadian" Internet pharmacies and were represented as being of Canadian origin.
However, only 15 percent of the "Canadian" drugs in the parcels examined actually originated in Canada. The remaining 85 percent were manufactured in 27 different countries. In addition to having been falsely promoted as being of Canadian origin, many of these drugs were not adequately labeled in English to help assure safe and effective use.
Thirty two of the pharmaceuticals sampled, representing three distinct drug products, have been determined to be counterfeit. FDA is working closely with the Canadian drug regulatory and law enforcement authorities on this matter. FDA will take appropriate action to keep these counterfeit products out of the U.S. drug supply and pursue actions against those responsible for attempting to defraud the American public.
Posted: December 2005
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