Industry Bickers Over How To Catch Fake Drugs

MATTHEW PERRONE

WASHINGTON (AP) ⿿ The news this week that a fake version of the cancer medicine Avastin has made its way into the United States highlights a longtime concern: There are few safeguards to make sure fake drugs can be spotted before they make it to your doctor's office.

For more than a decade, public safety advocates have called for a tracking system that would enable everyone from manufacturers to wholesalers to doctors to verify the authenticity of prescription drugs through electronic tags or barcodes. But bickering between those parties over the cost and scope has stalled the effort.

The Food and Drug Administration is expected to issue a proposal for the technology behind a tracing system later this year ⿿ five years after a law passed ordering the agency to develop a plan. But in the meantime the U.S. system continues to be vulnerable to counterfeits, as highlighted by the Avastin case.

"This counterfeit Avastin isn't something that was ordered over the Internet, or sold on a street corner," said Allan Coukell, director of the Pew Charitable Trusts' medical group. "It illustrates that it's possible to sell a fake drug into a legitimate distribution system."

The FDA on Tuesday announced it is investigating fake vials of Avastin sold to U.S. physicians by Quality Specialty Products., a foreign supplier that also does business as Montana Health Care Solutions.

U.K. regulators first discovered the counterfeits in December and seized 167 packs, though more than three dozen others had already been sold to the U.S., according to the country's Medicines and Healthcare Products Agency. The FDA confirmed that the drugs were counterfeit last week.

The fake Avastin vials, some of which were labeled in French, were distributed by a Tennessee-based supplier. FDA officials say the supplier was licensed by the state health department.

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