FDA Alerts Doctors on Fakes

Publication: The Wall Street Journal

Author: Jonathan D. Rockoff and Christopher Weaver


04/20/2012 - The Food and Drug Administration warned more than 50 doctors and medical practices in the U.S. that they may have bought a fake version of the cancer drug Avastin, in a sign of just how widely counterfeit medicines can spread.

In the two-page letters, the FDA asked doctors and medical practices in 13 states from Alabama to Washington to avoid using the fake drugs. These counterfeits "may cause harm to patients, because they may be unsafe or ineffective," said the letters, signed by an official in the FDA's drug-security office.

Avastin is an injectable drug made by Roche Holding AG's Genentech unit. The drug is widely used to treat patients with certain colon, lung and other cancers. Both the FDA and Roche said they hadn't received any reports about patients taking the counterfeits or being harmed by the fakes. The FDA has said that counterfeit versions of Avastin didn't contain the real drug's active ingredient.

In February, the FDA warned that a batch of fake Avastin had surfaced in the U.S.

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By purchasing cheaper foreign drugs, doctors can increase their profits, say investigators probing the purchases. If doctors buy cheaper price-controlled drugs from other countries, but bill managed-care companies and government health programs for the full price of FDA-approved drugs, the difference goes to their bottom lines, the investigators say.

"It's deeply concerning that doctors are buying drugs of uncertain provenance," said Allan Coukell, the director of medical programs at the Pew Health Group. "What we're seeing may be the tip of the iceberg," Mr. Coukell said.

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Read the full article, FDA Alerts Doctors on Fakes, on The Wall Street Journal's website.

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