The FDA has issued letters to 19 US medical practices that purchased medication from a foreign supplier, Quality Specialty Products (QSP), warning that drugs distributed by QSP are known to be unapproved by the FDA, and in at least one instance verified counterfeit.

QSP, also known as Montana Health Care Solutions, has been identified by the FDA as the distributor of counterfeit Avastin. Roche AG, the manufacturer, has said that the counterfeit Avastin was tested and found to contain no active ingredient. Avastin is FDA approved for use in metastatic colorectal cancer, advanced nonsquamous non–small cell lung cancer, metastatic kidney cancer, and glioblastoma.

The FDA has issued letters to 19 US medical practices that purchased medication from a foreign supplier, Quality Specialty Products (QSP), warning that drugs distributed by QSP are known to be unapproved by the FDA, and in at least one instance verified counterfeit.

QSP, also known as Montana Health Care Solutions, has been identified by the FDA as the distributor of counterfeit Avastin. Roche AG, the manufacturer, has said that the counterfeit Avastin was tested and found to contain no active ingredient. Avastin is FDA approved for use in metastatic colorectal cancer, advanced nonsquamous non–small cell lung cancer, metastatic kidney cancer, and glioblastoma.

Said Thomas Christl, Acting Director of Drug Security, Integrity and Recalls, “The agency is very concerned that the products may cause harm to patients because they are unsafe or ineffective,” and requested that the 19 practices stop administering medicines purchased from QSP, Volunteer Distribution or any other unapproved foreign source.

“These products may be from unknown sources, have unknown ingredients, and may not have been manufactured, transported or stored under proper conditions required by U.S. law, regulations, and standards,” he warns.

In the letters Christl also states that “Purchasing these products from a foreign source violates the Federal Food, Drug and Cosmetic Act (FFDCA) and other federal statues rendering these drugs illegal.”

Quality Specialty Products is located in St. Christopher, St. Kitts, an island in the West Indies, east of Puerto Rico. Volunteer Distribution, in Gainesboro, TN, distributed QSP’s products within the U.S. to the practices.

The FDA warns that “A high percentage of these products are injectable cancer medications whose quality could be adversely affected if they are not stored or transported under specific temperatures.”

The FDA also said that the products sold illegally through QSP and Volunteer Distribution were not on the list of current drug shortages, “The agency determined that none of the purchased products are currently in shortage in the U.S. and that FDA-approved versions of the drugs are available in adequate supply to meet current demand.”

Said Roche and Genentech in a statement, “The counterfeit product is not safe or effective and should not be used. Chemical analyses of the counterfeit vials tested to date have confirmed the product does not contain the active ingredients for Avastin.”

Notably among the individual practitioners that received notices, The Beverly Hills Cancer Center received notice on February 10th of purchasing unapproved products from QSP including counterfeit batches of Avastin. The Beverly Hills Cancer Center has received recent acclaim in a profile in October 2011 by Los Angeles Times reporter Peggy Stacy. Additionally the following practices in California, Illinois and Texas received notices:

QSP client locations 2

  • Dennis Casciato, MD
  • Phillip L. Chatham, MD
  • Weber Chen, MD
  • Mohamed Ghraowi, MD
  • Mark Goldstein, MD
  • Naresh K. Gupta, MD
  • Raymond Heung, MD
  • Eddie Hu, MD
  • Hany Khalil, MD
  • Phyllis Klein, MD
  • Harry Menco, MD
  • R. Deva Nathan, MD
  • Martin Palmer, MD
  • Nabil Phillips, MD
  • Omid S. Shaye, MD
  • Patrick Sheehy, MD
  • Glenn Tisman, MD
  • Rangachari Vasan, MD