National Drug Track-and-Trace Debate Continues: Will Lawmakers & Industry Ever Agree?
06-29-2012
The media has continued to highlight reports of counterfeit medications and their associated dangers to consumers.
The topic has also been heavily discussed by lawmakers on Capitol Hill during negotiations involving the “must pass” U.S. Food and Drug Administration (FDA) funding bill. Recently, the agency’s decade-long work on a “track-and-trace” system for medications was delayed as the U.S. Senate and U.S. House of Representatives accepted defeat in trying to include the measure in FDA’s funding bill.
Regulators and healthcare companies have been talking about a track-and-trace system for nearly a decade and see the benefits, such as product authentication and effective recall management, associated with implementing such a plan.
So what is keeping both sides from coming to an agreement?
FDA’s proposed tracking plan would require individual vials of medicine to carry their own serial numbers and the creation of a unified technology infrastructure. Pharmacy officials estimate that implementing such a plan would cost more than $6 billion just for pharmacies alone. They, along with drugmakers and distributors, have formed a coalition that is pushing for a system focusing on tracking much larger “lots” of drugs rather than the individual packages.
The group claims its plan paves the way for the implementation of more stringent rules later on down the line. During negotiations involving FDA’s funding bill, lawmakers could not come to an agreement on how quickly the U.S. would move toward this “unit level” system.
Although a national track-and-trace system may still be on hold, California is ramping up its efforts to institute its own version by 2015. The European Union will also require a unique identifier on drug packages beginning in 2016.
If the rise in counterfeit medications steadily continues to affect U.S. consumers, it is safe to assume that a national track-and-trace program will eventually be initiated. In fact, some lawmakers say they will try to introduce the idea as a stand-alone bill later on this year. Businesses within the pharmaceutical industry should stay tuned to news revolving around this topic and make sure they are prepared to effectively respond to any future pending legislation.
Do you think a trace-and-trace system would improve the verification of medications through the drug supply chain? How long do you think it will be until a national program is launched? We welcome your comments below.
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