Faulty Drugs

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FDA Advisory

So-Called ‘Canadian’ Products Really From Other Countries

An FDA operation found that nearly half of the imported drugs that the agency 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. A number of these products also were found to be counterfeit.

“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,” says Acting FDA Commissioner Andrew von Eschenbach, M.D. “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.”

The FDA conducted its “Operation Bait and Switch” over a few days in August 2005 at the John F. Kennedy International Airport in New York, Miami International Airport, and Los Angeles International Airport. The FDA examined all mail parcels suspected of containing pharmaceuticals sent from four countries–India, Israel, Costa Rica, and Vanuatu–that the agency had previously noticed were sources of drugs apparently ordered from pharmacies alleged to be Canadian.

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 these “Canadian” drugs 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, were determined to be counterfeit. The FDA is working closely with the Canadian drug regulatory and law enforcement authorities on this matter. Visit www.fda.gov/importeddrugs/ for more on imported drugs and www.fda.gov/counterfeit/ for additional information on counterfeits.

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