Getting Back on Track (and Trace)

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Counterfeit medicines are not just a theoretical problem anymore. Now is the time to close a major loophole that allows the purveyors of false products to prey on an unsuspecting American public.

This article published with permission from The Burrill Report.

Counterfeit medicines are growing at such an alarming rate that the issue finally made it onto the recent Camp David G8 agenda. Counterfeit Avastin has found its way into America’s legitimate supply chain. It’s not just a theoretical problem anymore. Now is the time to close a major loophole that allows the purveyors of false products to prey on an unsuspecting American public.

Now is the time for a national standard for pharmaceutical track and trace that would enable manufacturers, wholesalers and distributors to provide documentation or a “pedigree” on the chain of custody of drug products, including identification of each prior sale, purchase or trade of a drug, along with the associated dates and parties involved.

Earlier this month, 11 people were charged with the record-breaking $75 million drug heist in March 2010 from the Eli Lilly warehouse in Enfield, Conn. Fortunately, all of the stolen drugs from the Lilly warehouse were recovered before they could be re-introduced into the legitimate supply chain. But we won’t always be so lucky.

Criminals are going to continue to attack our drug supply because they are always going to be attracted by the high value of drugs in the U.S. market. You can’t prevent criminals from making attempts, but you can make it a lot more difficult.

Now is the perfect time to strike a blow for drug safety. There’s a general placeholder in the Senate version of the Prescription Drug User Fee Act legislation that requires more specifics. Now is the time for the FDA to roll up its sleeves and work with Congress to come up with a national standard instead of leaving it up to each state to come up with its own standard (as in California). In many respects, the only thing worse than having no standard is to have 50 different standards that create 50 different ways for counterfeiters to game the system.

This isn’t a new problem. The Prescription Drug Marketing Act of 1987 was signed into law by the president in 1988. It was enacted to ensure that drug products purchased by consumers are safe and effective, and avoid the unacceptable risk to American consumers from counterfeit, adulterated, misbranded, subpotent or expired drugs. Both Congress and the FDA recognized that such legislation was necessary to increase safeguards in the drug distribution system and to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs.

In 2004, during my service as an FDA Associate Commissioner, I served on the agency’s first Counterfeit Drug Taskforce. Our report outlined a framework for public and private sector actions that could further protect Americans from counterfeit drugs, including implementation of new track and trace technologies to meet and surpass goals of the Prescription Drug Marketing Act. Our framework called for a multi-layer approach to address the problem and included the following measures:

Secure the product and packaging
Secure the movement of drugs through the supply chain
Secure business transactions
Ensure appropriate regulatory oversight and enforcement
Increase penalties
Heighten vigilance and awareness
Foster international cooperation

But there’s always the danger of allowing perfection to get in the way of the (public) good. Implementing the Prescription Drug Marketing Act has been a nightmare for 1,000 reasons — not the least of which is a single, FDA-mandated track-and-trace technology.

But time marches on. Technological advances since 1988 provide a plethora of possibilities. It’s time for the FDA to work with all stakeholders and put a national standard in place. And the FDA won’t be acting alone.

“The logical next step in this policy is to work to improve the safety of the drug distribution system that gets drugs from manufacturers to the pharmacists and other providers who dispense them to patients,” says Senator Tom Harkin, D-Iowa. “The FDA currently lacks the authority to establish a uniform, comprehensive national system to secure the pharmaceutical distribution supply chain.”

It’s time to give the FDA the authority it needs to put 21st century track and trace into commission on behalf of the public health.

Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.