Counterfeit Avastin scandal widens; injectables emerge as a new focus of criminal mischief

At some point in the past week or so, as the news about counterfeit Avastin (bevacizumab) showing up in numerous US clinic offices, FDA posted another announcement that it has been investigating similar intrusions of counterfeit Faslodex (fulvestrant; AstraZeneca); Neupogen (filgrastim; Amgen); Rituxan (rituximab; Genentech) and Herceptin (trastuzumab; Genentech). “FDA is aware of promotions and sales of unapproved injectable cancer medications direct-to-clinics in the U.S, which most likely were administered to patients,” it said in a document dated Jan 13 (it is not clear to whom this notice was sent at that time.)

There are at least two deeper implications to these incidents: FDA continues to point out that, while there are many drugs in short supply right now, including injectable oncologics, none of these drugs are (and therefore, attempting to obtain them from non-US sources is unwarranted besides being illegal); and all of them are shipped as temperature-controlled, cold-chain products. While there is no direct evidence, as yet, that the drugs were not shipped under temperature-controlled conditions, if an illegal distribution path is being used to transport them, it’s doubtful that appropriate temperature controls are being employed. (The fake Avastin is known to contain no active ingredient, so the effects of absent temperature control would be irrelevant, but this might not be so for all the drugs. On the flip side, there have been no public announcements of serious adverse events—so far.)

Reuters, Wall Street Journal and other news articles indicate that fake products started showing up in Europe (Switzerland, Denmark and the UK), and then the UK Medicines and Healthcare Products Agency (MHRA) notified FDA in December. But at least one of the 19 clinics in the US identified as receiving counterfeit Avastin said that they had stopped acquiring product from a distributor, Montana Healthcare Solutions, which is either a US subsidiary of, or trading partner with, a British wholesaler named Quality Specialty Products. A letter that FDA sent to the 19 clinics was cc’d to a company of that name in St. Kitts. Another distributor, Volunteer Distribution of Gainesboro, TN, has also been identified by FDA as a participant (and one news source identified this company as a licensed distributor in Tennessee.)

By Feb. 17, follow-up stories began noting that FDA and the US pharma industry have been wrangling over product-authentication and track-and-trace systems for years, with no national system yet in place. There is legislation in Congress (such as HR 3026) on point, but no new effort to get it passed into law.