Counterfeit drugs show need for tracking

Courtesy FDA

U.S. officials seized Altuzan, a Turkish version of Avastin.

The discovery of a second batch of a phony cancer drug in the United States this week has frustrated regulators in California, where the nation's most stringent law to track and trace pharmaceuticals was passed in 2004 but has yet to be implemented.

Federal authorities said Tuesday that a counterfeit version of Genentech's best-selling cancer drug Avastin has been found in undisclosed locations - less than two months after another bogus version of the same drug made it to medical offices in Southern California, Texas and Illinois.

"It's a situation that really is stunning the medical community right now. Everybody begins to question every drug," said Dan Wood, spokesman for the Medical Board of California, the state agency that regulates physicians.

Fake prescription drugs, along with diluted or expired medications, are a growing problem in the United States and around the world.

About 11 times as many cases of counterfeit drugs were verified in 2010 as in 2002 - 2,054, up from 196 - according to the Pharmaceutical Security Institute, a nonprofit, industry-backed organization that performs the analysis.

The World Health Organization estimates that less than 1 percent of medicines in developed countries are phony. But the discoveries of the counterfeit Avastin show the U.S. drug supply chain is vulnerable.

The United States has no national system for tracking drugs, yet its complex drug supply chain involves a maze of wholesalers and secondary wholesale marketers.

In 2004, California lawmakers tried to address the problem in the state by approving the nation's first electronic drug-tracking system. The law requires each legitimate bottle or vial of prescription drugs to carry a unique serial number. That creates an electronic record every time the drug changes hands - from manufacturer to wholesaler to the pharmacy.

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Counterfeit drugs show need for tracking