House passes track and trace bill to fight counterfeit drugs

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As ACSH discusses in its publication, Counterfeit Drugs: Coming to a Pharmacy Near You, counterfeit drugs fake, substandard, adulterated or falsely labeled are a threat to global health. In fact, last June, 1.4 million counterfeit packets of Coartem, a malaria drug produced by Novartis, were found in a shipment from China to Angola, where more than 1 in 10 individuals is diagnosed with malaria every year. And even though the U.S. drug supply is among the most secure in the world, cases of counterfeit drugs have been increasing here in the past few years. To counter this problem, the House passed a bill this week, H.R. 1919, the Safeguarding America s Pharmaceuticals Act, which creates a nationally implemented system in which drug products are tracked and traced by manufacturers, distributors, and pharmacies around the country.

Although this is a step in the right direction, even supporters of the bill believe that it needs to be expanded to require monitoring at the unit level, which is where counterfeiting usually occurs. In order to address this concern, the bill has also created a process for collaboration between the FDA and stakeholders to analyze logistics surrounding moving towards a unit-level monitoring system. However, this might not happen until as late as 2030.

To which Allan Coukell, of BScPharm and deputy director of medical programs at the Pew Charitable Trusts says, You really have to look at the House s (bill) as phase one of what everybody agrees has to be a two-phase approach. But on a positive note, H.R. 1919 s sponsor, Representative Bob Latta (R-Ohio) says, By replacing the current patchwork of multiple state laws with a uniform national standard we improve safety, eliminate duplicative regulations, and create certainty for members of the pharmaceutical supply chain.

This bill also comes on the heels of recent legislation passed by a Senate committee which clarified the federal and state roles in terms of overseeing compounded drugs. This bill also contains a clause that requires a transition to electronic unit-level drug tracing in no more than 10 years.

ACSH s Dr. Gilbert Ross noted that Americans have been rather oblivious to this problem, since our safeguards are relatively strong and widespread adulteration with resultant sickness and death have not been reported here. The problem is vast and under-reported in the third world, but the fact that we have been spared is no reason for complacency. I m glad that this new effort is finally being implemented, even as a precautionary measure.