The Food and Drug Administration says counterfeit Avastin, a costly cancer drug, has made its way to doctors in the United States.
The counterfeit doesn't contain the active ingredient. Genentech, the Roche unit that makes Avastin, said Tuesday it's aware of the problem and is working with the FDA and law enforcement.
Last week, the agency sent 19 letters to cancer specialists in California, Texas and Illinois who are believed to have purchased the fake Avastin.
It's not clear how many patients may have been treated with the counterfeit drug, or whether more of it may be in circulation.
The FDA says the substance came from a foreign supplier called Quality Specialty Products. It also goes by the name Montana Health Care Solutions. (An Internet search turned up companies with these names that do not appear to be the ones the FDA is referring to.) The agency says the drug was distributed by Volunteer Distribution in Gainesboro, Tenn.
The fake Avastin comes in 400-milligram vials that cost $2,400. Last year Avastin racked up more than $2.5 billion in sales.
Counterfeit versions of diet drugs, Lipitor and a flu medication called Tamiflu have been found in this country before. But so far fake cancer medicines have been rare.
In this case the motive is very clear — Avastin costs a lot. And patients often get tens of thousands of dollars' worth over the course of treatment.
Avastin is approved to treat colorectal, lung, kidney and brain cancer. It was in the news last December when the FDA withdrew approval to treat advanced breast cancer.
The drug was among the first so-called designer drugs for cancer — molecules that target a particular protein or cell receptor that cancer cells need to keep growing. In Avastin's case, it blocks a growth factor called VEGF that's important in the formation of new blood vessels.
The FDA, acting on a tip from its British counterpart, has identified three lot numbers on the packages of counterfeit Avastin.
The labels look different from legitimate Avastin — they have foreign text as well as English, and they carry a Roche logo. Legal Avastin has labels with only English text and the name Genentech, a Roche subsidiary.
Doctors who got the FDA's letters are being told to stop administering products from Quality Specialty Products or Volunteer Distribution, "or any other unapproved foreign source."