FDA and Roche Warn of Counterfeit Avastin

February 16, 2012
Amy Ritter, PhD

Amy Ritter was Scientific Editor, BioPharm International.

FDA and Genentech, a member of the Roche Group, have issued warnings about counterfeit versions of the injectable cancer drug, Avastin, circulating in the US. According to the FDA safety alert, the counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy.

FDA and Genentech, a member of the Roche Group, have issued warnings about counterfeit versions of the injectable cancer drug, Avastin, circulating in the US. According to the FDA safety alert,  the counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy. FDA issued letters to 19 medical practices that purchased unapproved cancer medications from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products.

In their press statement, Genentech provides information that can be used to differentiate real product from counterfeit. Genentech says that all cartons and vials approved for use in the US have “Genentech” or “Genentech, a member of the Roche Group” printed on the labels, the lot number on the carton and vial should be 6 digits with no letters, the expiry date is formatted as a 3-letter month and 4-digit year, the date of manufacture is not printed on the carton or vial, and all the text on the vial labels, cartons, and package inserts is English. Genentech adds, “Patient safety is Roche and Genentech’s primary concern. We are working with the U.S. Food and Drug Administration (FDA) and law enforcement to aid their evaluations, determine the source of the counterfeit drug, and prevent its further distribution.”

In January 2011, FDA issued a notice to health care providers about the risks of purchasing unapproved injectable cancer medications from unlicensed sources. The impetus for the notice was the shortage of some injectable cancer drugs that might prompt health care providers to shop unapproved sources to obtain necessary drugs. FDA said in its notice that it may authorize limited importation of a drug in short supply, but that such medications would distributed in the US through a controlled network, and would not be available to practitioners through direct-to-clinic solicitations.

In this case, FDA says that none of the unapproved cancer medications purchased from Volunteer Distribution are in shortage in the US. Nor have other products including Faslodex (fulvestrant), Neupogen (filgrastim), Rituxan (rituximab), and Herceptin (trastuzumab) available from unapproved suppliers been in short supply. The identification of a counterfeit cancer drug (probably purchased at a less-than-retail price) underscores the old saying that if it seems too good to be true, it probably isn’t.

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