Improving the Integrity of the Drug Supply in a Global Marketplace

Last week FDA announced that a counterfeit version of a cancer drug had surfaced in the United States. It was labeled as Altuzan, a product approved in Turkey and not approved in the United States. The counterfeit did not contain the active ingredient of Altuzan. Unapproved foreign drugs, including the counterfeit, were purchased by medical practices in the U.S. from a foreign supplier.
This discovery comes only a few months after FDA informed 19 medical practices in three states that they had purchased unapproved foreign drugs, which may include the counterfeit version of Roche’s Avastin. Roche is the company that manufactures Avastin approved for marketing outside of the United States. This counterfeit also did not contain the active ingredient of Avastin. This counterfeit was also purchased from foreign suppliers and was also nothing but a sham.
For patients with cancer, combating the disease is difficult enough. But to learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable.
The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). Genentech’s Avastin products are safe and effective for their intended uses, therefore cancer patients that have been receiving these products should not be concerned.
FDA does not know whether patients actually received counterfeit Altuzan or Avastin. Nevertheless, these cases illustrate that in today’s global economy much more needs to be done to ensure the integrity of the drug supply.

Margaret Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

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