The report comes on the heels of major arrests for drug counterfeiting in China, Canada, and the US. In the most recent example at the end of August, the US Food and Drug Administration (FDA) and the US Attorney for the Western District of Missouri, indicted 11 individuals, a drug repacker, and two wholesale distributors in cases related to the sale of allegedly counterfeit versions of Pfizer's cholesterol-reducing drug Lipitor (atorvastatin) originating in Latin America. A case involving Lipitor - the world's top-selling medication - has also recently been uncovered in the UK.
"The business of selling fake prescription drugs to unsuspecting consumers is burgeoning, and is a global industry," said Peter Pitts, senior fellow for health care studies at the Pacific Research Institute and director of the CMPI.
Pitts' report estimates counterfeit drug sales will grow 13 per cent a year through to 2010, compared to just 7.5 per cent estimated annual growth for global pharmaceutical commerce. Many of the products sold via drug traffickers contain ingredients that could be harmful, and these products are coming from illegal operations with very poor controls. Many of these operations use phony, fly-by-night websites, he said.
The American debate about health care affordability and access is directly linked to international prescription drug counterfeiting. Not only are counterfeit drugs extremely dangerous and many times lethal, but also they are a potential source of funding in the murky world of crime and terror.
"Nearly $39 billion, or 11 per cent of global pharmaceutical commerce will be counterfeit this year," added Mr. Pitts. "By 2010, that number will nearly double. We must enact controls to strengthen the security of our health care system from outside threats."
The findings of the report will no doubt be used by the US pharmaceutical industry in its efforts to negotiate a block on cross-border trade. The industry is particularly against the practice by US consumers of ordering cheaper prescription drugs from Canada and other foreign countries - which eats into profits and allegedly creates a door for the entry of counterfeit drugs into the US marketplace.
"The increasing flow of counterfeit drugs represents a significant public health threat," said Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs at the U.S. Food and Drug Administration. We must step up our efforts to safeguard the drug supply -- we certainly should not weaken those controls."
In July 2003 the then Commissioner of Food and Drugs Mark McClellan, formed a Counterfeit Drug Task Force specifically to tackle the issue of increasing drug counterfeiting. One of the findings of the task force was that companies should make use of track-and-trace technologies - such as bar coding and radiofrequency identification (RFID) tagging - to make it harder to get fake drugs into legitimate distribution channels.
The release of the report comes just ahead of a conference, to be held on 20 September in Washington DC, that will bring together international experts on illegal pharmaceutical regulation, security, and trade to discuss the threat of illegal, cross border drug trafficking.