FDA’s Placebo for Counterfeit Drugs
By: J. Alan Cates

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This much is true. Counterfeit drugs pose a clear and present danger to the public – and to our nation’s billion-dollar pharmaceutical industry. The FDA’s recent decision to use radio tags to track drug shipments from manufacturer to major wholesalers may dampen diversion of legitimate drugs. However, the real threat is not legitimate – but counterfeit drugs. Unmitigated risk remains. Terrorist-tainted or useless knock-off drugs can still be unwittingly prescribed by trusted physicians and dispensed by community pharmacists to the sick and dying.

FDA acknowledges the rapidly growing problem with counterfeit medicines, but infers the risk is to those citizens who purchase product from international markets. The FDA should have said the real threat is the bulk of importation and manufacture of fake pills by organized criminal enterprises. Authentic-looking pills co-mingle in the wholesale distribution chain and ultimately contaminating retail pharmacy inventory.

The FDA has acknowledged that it cannot stay ahead of illegal importers, clandestine manufacturers, and a growing host of gray-market wholesalers. The economic truth is that it is quite profitable to counterfeit high-demand medications. With minimal risk of detection, it is utterly predictable that counterfeit medicines will continue to increase. Profit-blinded wholesalers have little motivation to question drug pedigree or purity. Expensive testing is imply inconsistent with gross profit, leaving criminal importers and questionable wholesaler fearless. With on one testing at the public retail level, there was nothing to protect the pubic from counterfeit drugs – until now.

The nonprofit Fraud Prevention Institute (FPI) is moving swiftly to establish routine scientific drug testing of retail pharmacy inventory. With a start-up grant from UPNI, an independent network of concerned community pharmacists, FPI has instituted proactive counterfeit drug testing at participating Southern California pharmacies. With mutual concern for public protection, the prestigious USC School of Pharmacy provides independent scientific testing and analysis services.

Targeting medications favored by fraudsters, sealed and coded samples are sent daily to USC for lab analysis. It tampered or counterfeit product is detected, FPI will work with the pharmacy for prompt consumed notification and recovery.

This volunteer effort provides ongoing public assurance with pharmacies displaying a SAFE (Security Assessed For Excellence) certificate are committed to public protection. Equally important, counterfeiters are on notice that a prompt and effective detection routine is now in place.