Criminal investigations for counterfeit, diverted drugs skyrocketed in 2012

FDA doesn’t broadcast the level of activity undertaken by its Office of Criminal Investigations (OCI) each year, but the information usually trickles out in industry presentations. For FY2012, the count of such investigations reached 170—a huge increase over the FY2011 count of 59. Putting that in a longer-term context, the number of cases were in the 10-30 range in the first few years of the last decade, then jumped to the 50-70 range in the late 2000s. A query to FDA about the jump elicited this response: “The increase in OCI counterfeit cases initiated in FY 2012 was due, in large part, to cases that were developed from the counterfeit Avastin and Altuzan incidents.”

The cases being referred to occurred roughly a year ago, when it was discovered first that Genentech’s Avastin was being illegally imported from the Middle East and sold to individual doctors’ offices, and then that some of it was actually counterfeit. Letters were sent to some 19 offices notifying customers that the drug they had purchased was illegal; subsequently, at least one doctor pleaded guilty to FDA violations, and investigations were being pursued with others. Other misappropriated drugs were caught up in the same illegal-importation scheme.

OCI is charged with investigating, among other things, drugs that are counterfeit, diverted (from, say, a Medicare-funded, dispensed prescription, back into commercial distribution), stolen (particularly cargo theft, which now gets special attention from FDA) and “economically motivated adulteration,” which covers a variety of situations, notably the contaminated heparin, mixed with an oversulfated chondroitin, that showed up in 2008 in the US, and led to the deaths of dozens of patients. Stolen or diverted pharmaceuticals might seem to be more of a economic than health risk, but the fact is that many drugs require controlled storage, and once they are removed from those controls, can become ineffective at least and potentially harmful.

FDA is usually careful to note that the count of OCI cases is not directly proportional to the volume of illicit activity that might be going on; among other factors, it is a measure as well of how actively OCI pursues investigations. A 2011 report from FDA on the counterfeit/diverted drug situation sums up the point:

[R]esults presented should not be interpreted as a scientific representation of current drug supply chain trends or a comprehensive review of problems associated with the drug supply chain. Instead, these results should be viewed as an illustrative representation of certain problems and vulnerabilities that we have observed in the drug supply chain.

However, even with all those qualifiers, a tripling of OCI cases leaves a nagging sense that there is, in fact, a trend here. The statistics play into the debate of, among other things, the need to impose a track-and-trace system on drug distribution in the US (something that is now proceeding apace in Europe, China and elsewhere). Defenders of the status quo maintain that the “normal chain of distribution” (from manufacturer to authorized wholesaler to dispensing pharmacy) is well protected. But—if there is smoke, is there also a fire?