Expert says FDA will be more vigilant in inspecting Chinese imports

WASHINGTON The Food and Drug Administration plans to be more watchful in inspecting overseas active pharmaceutical ingredient production facilities in the wake of the heparin contamination, according to a counterfeiting expert.

“As a whole, the FDA is going to be much more aggressive in inspecting and approving Chinese (drugs), particularly APIs, coming into the United States,” Donald deKieffer, a principal at the deKieffer & Horgan law firm, said. An expert on international counterfeiting and diversion, he said there are probably 30–40 counterfeiting rings operating in the U.S., some of which have substantial operations.

DeKieffer detailed a Florida counterfeiting ring led by Michael Carlow, who set up wholesale distribution companies, established relationships with wholesalers and sold them stolen medicines at discounted prices.

He then started buying medications in foreign countries at substantial discounts and shipping them to the U.S. for distribution. He used counterfeit pedigrees to authenticate the product, which he sold to wholesalers that then sold the drugs to other wholesalers. The counterfeit product ended up in warehouses of the big three distributors: McKesson, Cardinal Health and AmerisourceBergen.

DeKieffer said firms need to know their suppliers and customers. Checking to make sure customers are not in any databases of known diverters or counterfeiters is essential. “It’s always been astonishing to me that some very large and sophisticated manufacturers ... continue to do business with known crooks ... to whom they’re selling, both in this country and overseas. They’re selling lots and lots of product,” he said.