FDA posts warning about illegally imported Botox--another breach of pharmaceutical distribution security

There has been another breach of security in the distribution of drugs to doctors’ offices—but the overall reaction has been surprising muted. On Dec. 19, FDA posted a notice about a alert it has sent to 350 doctors’ offices (the list is available here) warning them of purchasing unapproved version of Botox (botulinum toxin) “and other medications” from a group of companies associated with a company called Canada Drugs: Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care. QSP is the same company implicated in the Avastin scandal from earlier this year, when recognizably counterfeit versions of the drug were found in dozens of oncologists’ offices.

In that case—and what seems, on the surface, to be the case here—individual doctor’s offices ordered products from small distributors in various parts of the country; some of these distributors have openly promoted their inventory at one price for “domestic” product and another, lower one for “international” product. The fake Avastin showed up, in some cases, with labels written in an Arabic language (at some point in the movement of those shipments, the products passed through Egypt). Whether fake or not, it is illegal for companies or individuals to import unapproved products from abroad for commercial distribution. To date, there has been one conviction of an oncologist who pleaded guilty to receiving illegally imported product, although other cases are open.

Allergan hasn’t issued a public statement but in communications to physicians, wrote that “We cannot confirm the safety or authenticity of products that are imported from unauthorized distributors, which is why it’s critically important that physicians purchase Botox Cosmetic or Botox directly from Allergan or from Allergan-authorized distributors.” The company also notes that it equips its packages with a hard-to-duplicate hologram as a security measure.

On top of everything else about this, it’s worth noting that Botox is a cold-chain pharmaceutical that requires 2-8°C storage and shipping.

FDA fatigue?

FDA’s Office of Drug Security, Integrity and Recalls, having dealt with the widespread compounding-pharmacy problem and the earlier spate of counterfeit drugs this year might be feeling battle-weary at this point. The notice about Botox concludes with a discreet comment that, this year, “FDA has issued letters to medical practices in the United States that purchased unapproved medications from foreign suppliers five times: on February 10, April 5, April 23, June 28, and September 10.” In addition, there have been several notices of counterfeit product floating in circulation. All this has occurred against a backdrop of intense negotiation over federal e-pedigree rules, but as yet, no federal law has passed.