FDA report models counterfeiting and diversion patterns in US

FDA/OCI badgeA new report form the US Food and Drug Administration (FDA) has analysed historical cases of medicine counterfeiting and diversion to gain a better understanding of the methods used by criminals and help prevent incidents in future.

The report - available here - provides a snapshot of the illegal medicines trade in the USA rather than a comprehensive analysis, but nevertheless found various trends of note.

For example, solid oral dosage forms such as tablets or capsules were the most likely to be targeted by counterfeiters or diverters, while the suspects identified in cases brought by the FDA's Office of Criminal Investigations (OCI) were most commonly wholesalers (27 per cent) and pharmacists (13 per cent), followed by doctors (9 per cent), sales reps (5 per cent) and other pharmacy workers (4 per cent).

The document takes one example of counterfeiting and two diversion schemes as model systems to extract initial impressions on the illegal medicines trade, based on OCI cases investigated over a five-year period between 2003 and 2008.  That sample included 188 different suspects and over 1200 different drug products, which represented about 50 per cent of the total OCI judicial cases over the timeframe.

The counterfeiting case study laid out in the report involved pharmacist James George, who was convicted in 2006 of receiving counterfeit versions of two erectile dysfunction drugs - Pfizer's Viagra (sildenafil) and Eli Lilly's Cialis (tadalafil) - from Chinese sources. George paid 30-35 cents for the tablets, compared to the average wholesale price for genuine Cialis of $9.55 and $13.55 for Viagra. A diagram of the case is given below:

FDA counterfeiting example

The document also describes two diversion schemes, one involving a wholesale distributor and another involving a pharmacist, in which legitimate product was taken out of the proper supply chain channels, raising the risk that patients be exposed to degraded, expired or otherwise deficient products.

The wholesaler diversion described often involved drugs which had been purchased or stolen from patients and/or stolen from manufacturers and then sold to drug wholesalers, who in turn, sold the drugs on to pharmacies. The drugs - which were typically high-value medicines such as HIV therapies - were then sold and dispensed to end-user patients.

The pharmacist diversion case involved taking samples of medicines supplied by pharmaceutical company sales representatives, breaking open the packages and fraudulently selling the drug on to patients at the retail price.

The FDA stresses in the document that the sample cannot be extrapolated to give any sense of national trends. Nevertheless, the report found that the top five drugs in order were Lilly's schizophrenia treatment Zyprexa (olanzapine); Viagra; Pfizer's blockbuster cholesterol medication Lipitor (atorvastatin) and antidepressant Zoloft (sertraline) and another anti-schizophrenia medicine, Johnson & Johnson's Risperdal (risperidone).

"For FDA to carry out its public health mission, it is important that the agency find ways to improve the security of the drug supply chain for US consumers," notes the report.

The information gleaned from the OCI review will help the agency describe potential threats to drug quality and integrity, identify vulnerabilities in the supply chain to diversion and counterfeiting and work out which types of drugs tend to be targeted by criminals.

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