Originally Published PMPN
January 2004
EDITORIAL
To Assure Your Customer, Secure Your Product, Not Your Profit
Manufacturers usually aren’t too happy when regulators poke around in their business. But when FDA released its interim report on counterfeiting last October, I swear I heard a round of applause.
Seems ideal, right? When manufacturers agree to consider voluntary controls suggested by FDA, patients can only benefit. Right?
Not everyone thinks so. Some observers wonder why industry welcomes an initiative that could increase their costs and limit their options. I recently heard speculation that manufacturers support anticounterfeiting efforts—as well as efforts to stem drug imports—merely because such efforts will stifle their competition.
Such suspicion took root last year when some drug makers restricted exports to Canada to stem the flow of reimported drugs. Attorney General John Ashcroft was later asked by some members of Congress to investigate whether these firms broke antitrust laws.
To combat counterfeit products, some manufacturers are looking at other restrictions. These efforts may also come under fire. Johnson & Johnson, for instance, is now asking its wholesalers to buy its products directly, rather than through other parties.
As manufacturers take steps to thwart counterfeiters, they will need to show that their efforts are to inhibit criminal activity, not competitive pricing. This will be one of the biggest challenges facing the drug industry in the coming years, says Peter Schmitt, founder of Montesino Associates. “There is growing tension in this area. Counterfeiting is real. It shows that the U.S. system of distributing drugs is not secure. Any number of people handle drug products until they are repackaged for the consumer. But, at the same time, there is understandable pressure, especially from price-squeezed seniors, to keep drug prices low. Pharmaceutical companies need to convince their customers that their efforts to secure their products are not attempts to limit competition.”
Many drug makers advocate a multiple-step approach, including packaging, just as FDA suggested. Pfizer offers a number of ideas, including track-and-trace systems. “Electronic Product Codes that are scanned by bar code or RFID technologies are particularly promising,” wrote Pfizer in a November letter to FDA. Also offering input to FDA was the Product Safety Task Force (PSTF), an industry coalition under the Healthcare Distribution Management Association. Members include GlaxoSmithKline, Merck, and other drug firms as well as pharmacies. Calling pharmacy repackaging “important,” PSTF suggested that “any recommendations to utilize authentication and track-and-trace strategies to secure the supply chain should be instituted by commercial repackagers as well.”
Track-and-trace solutions could help control counterfeiting. So could requiring repackagers and distributors to tighten up their operations. But the ultimate safeguards will be built into the product itself. Whether drug makers choose to use track-and-trace tactics, unit-of-use packaging, or covert or overt identifiers, drug products should not be turned loose in the supply chain without some means of protection.
Protecting each product through packaging and labeling offers an added benefit. It will show the U.S. consumer that product protection—not profit protection—is the priority.
Daphne Allen
Editor
Copyright ©2004 Pharmaceutical & Medical Packaging News
