Pharmaceutical Labeling

In 2003, the FDA announced a mass recall of the cholesterol-lowering drug Lipitor. The recall, triggered
by the discovery of counterfeits, affected more than 130,000 bottles.

While drug counterfeiting in the U.S. is still rare, the number of investigations are on the rise. According to the FDA, the number of counterfeit drug investigations has risen from an average of five per year in the 1990s to more than 20 per year since 2000.

Growing use of the Internet to purchase prescription drugs also complicates matters. “The biggest threat now to every pharmaceutical manufacturer is online buying of prescription products. How do you control that, make sure that the authentic product is being purchased, plus at the correct price?” asked Neil Sellars, director of product development and marketing for National Label Company in Lafayette Hill, PA. “Online purchasing brings everything to a whole new threshold.”

“Counterfeiting is a huge problem for the pharmaceutical industry as it relates to direct liability. The drug companies annually lose billions of dollars to very clever counterfeiters. From a cost standpoint, if they could reduce the amount of counterfeit drugs in the marketplace, that will help them with their bottom line,” said Bob Piefke, business development manager for Appleton in Dayton, OH.

Widely publicized cases such as the U.S. Lipitor recall of 2003 have catapulted the issue of counterfeited drugs into public view. All this attention has trickled down into the label industry, where many industry pundits report a rise in interest of tamper-evident and security packaging.

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