Unnecessary compromise

It took the U.S. 8½ years to land a man on the moon. Nearly a half century later, it's going to take the same U.S. more than a dozen years before accomplishing the seemingly mundane task of being able to electronically trace fake or tainted drugs back to their source of supply.

You would think that after 81 deaths and nearly 800 serious injuries from poisonous Chinese ingredients in heparin, repeated efforts to peddle fake Avastin to oncology practices, and numerous instances where counterfeit or stolen versions of atorvastatin (Lipitor) entered the supply chain—all in just the past six years—there would be a little more sense of urgency in Congress.

Last week, the House of Representatives passed legislation that would require manufacturers by 2015 to place trackable bar codes on every drug package they ship. But the bill doesn't require wholesalers or pharmacies to adopt a computerized tracing system that can make use of those bar codes for another dozen years—and even then only if the Food and Drug Administration comes up with a rule requiring them to do so. Given the FDA's track record on endlessly delaying the imposition of a universal identifier on every implantable device, there's no reason to believe a serviceable “track-and-trace” system will be in place even then.

The Senate version of the bill isn't much better. It requires traceability by wholesalers and pharmacies, but not until 10 years after enactment of the law.

There is one thing that both bills have in common. They would both preempt state laws that move more rapidly toward requiring the drug supply chain to adopt track-and-trace. While a few states have passed legislation requiring traceability, California, which often leads the nation in adopting new regulations, is slogging toward a 2016 deadline. That's hardly a rapid pace since its law, passed in 2004, has been delayed many times because of industry opposition.

And that's the part that is hard to understand. A group called the Pharmaceutical Distribution Security Alliance ostensibly backs the goals and timelines in both bills. But its real goal is preempting state laws such as California's, which would result in a patchwork quilt of regulations that could actually interfere with an effective, national track-and-trace system.

That's a legitimate concern. But the other issues being raised by the take-it-slow alliance—will the technology work; will it cost too much; will it lead to drug shortages—would be easily resolved if there were a national will to get the job done.

The global pharmaceutical marketplace cries out for an international track-and-trace system. Already, more than 80% of the active pharmaceutical ingredients in drugs used in the U.S. come from abroad, as do more than 40% of finished products. Within the U.S., there is a growing gray market for drugs where wholesalers rapidly exchange lots of soon-to-expire medications. New retail outlets such as Internet pharmacies and mass-market retailers are challenging traditional pharmacies and making it much more difficult to track drugs when they have to be recalled.

The roster of 25 companies and trade associations in the take-it-slow PDSA includes pharmaceutical and biotechnology drug manufacturers, wholesale distributors, pharmacies and the third-party logistics providers. Notably missing are hospitals, physician practices and the patients who actually use the drugs. Consumer groups such as Consumers Union and public health advocates such as Trust for America's Health have reluctantly endorsed the Senate version of the bill as a necessary political compromise to get something done.

If we had a Congress that truly cared about the safety and purity of the U.S. drug supply, such compromises wouldn't be necessary.

Follow Merrill Goozner on Twitter: @MHgoozner