The proliferation of fake drugs finally has the attention of Congress. Last week, the House of Representatives passed a bill requiring prescription medicine to be tracked electronically through the distribution system.
After years of counterfeit drug reports involving, among others, the cancer drug Avastin and the cholesterol drug Lipitor, it’s a meaningful gesture, but, according to a story on MedPageToday,some industry observers say the legislation doesn’t have enough bite to tame the rabid dog.
The Safeguarding America’s Pharmaceuticals Act would create a national “track and trace” system in which manufacturers, distributors and pharmacies would monitor drug products through the whole supply chain. It’s supposed to identify not only counterfeit drugs, but stolen and adulterated meds as well.
As we’ve seen all too often—remember the contaminated steroids from the Massachusetts compounding pharmacy last year? And last month’s report of another compounding pharmacy contamination in Tennessee? —drugs that aren’t made and shipped properly can be lethal. And the global scope of this commerce makes it difficult to regulate.
Critics of the proposed law say not requiring scrutiny at a drug’s unit level undermines its effectiveness. The unit level is a smaller sampling of a manufacturer’s total output. There might be thousands of units within a whole lot. And the unit level, say critics, is where counterfeiting occurs. It’s easier to steal or mess with small portions of a large lot of which only a bit is tested to escape tracking.
It’s the same principle of food inspection—a fish inspector might examine a few pounds of someone’s catch while most of the bounty remains unseen.
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