Anti-Counterfeiting, but Anti Rule

 

I’ve given anticounterfeiting much thought these past few weeks, and I’ve changed my mind. 
In one of our latest ePackage Newsletters, e-mailed to a number of you on July 31, I wrote that we would welcome an FDA rule requiring counterfeit-resistant packaging. On July 16, FDA had announced an initiative “to more aggressively protect American consumers from counterfeit drugs.” I was excited that FDA finally acknowledged that counterfeiting is a threat to U.S. manufacturers and consumers and is taking action. FDA plans to “better identify the risks and threats from counterfeit drugs.” In addition, the agency will “establish a public and private coalition to fight drug counterfeiting and distribution and develop new tools to aid in identifying, deterring, and combating counterfeiting.”

I am still excited, but I no longer believe that FDA should mandate packaging that deters counterfeiters. Make no mistake: I want manufacturers to use such packaging. And I want counterfeiters to know it will be in place. But I don’t want it to be a rule.

If it were, manufacturers would need to describe in their applications to FDA the specific elements used to make packaging hard to copy or to use later to authenticate products. FDA would need to approve the use of those elements. And manufacturers may then need to notify FDA if they needed to change them.

Such a system leaves manufacturers vulnerable in two ways. First, their plans to foil counterfeiters, which may involve covert printing and packaging methods, would be spelled out for others to see. FDA protects proprietary company information every day, but anticounterfeiting experts advise limiting knowledge to only a select few within the company. 

Second, a rule may make it difficult to update methods in order to stay one step ahead of the counterfeiters. The methods may then become static, giving counterfeiters the chance to catch up in knowledge and technology. And using different technologies for different markets or regions may be out of the question, given the challenge in keeping FDA informed.

FDA requirements aside, some fear that merely listing “new tools to aid in identifying, deterring, and combating counterfeiting” may be enough to tip off criminals. “I’m nervous about the government trying to help,” a seasoned packaging professional for a major drug manufacturer told me recently. “It will make public what we do.”

Instead, this professional wants tougher sentences for counterfeiters. His wish may come true. At the National Press Club in Washington, DC, this month, FDA commissioner Mark B. McClellan said FDA’s Office of Criminal Investigations is stepping up its search for counterfeiters to “pursue court action and criminal penalties.”

Stiffer penalties will help. But so can communicating the risks, without mandating the deterrents. FDA’s task force needs to get the attention of U.S. drug makers and consumers, many of which have felt that counterfeiting only happened outside our borders.

FDA needs to garner as much support for its initiative as possible. It may suggest tightening the supply chain and stopping drug reimportation, ideas that may not be too popular. At least until manufacturers and consumers fully know the risks.


Daphne Allen, Editor

 

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