FDA, Roche probe bogus Avastin found in U.S.

Fake Avastin has turned up in the U.S. drug supply. Roche ($RHHBY) and its U.S. unit Genentech say they're testing the "drug" in bogus vials, while the FDA and regulators overseas do their own detective work. The counterfeits apparently were distributed by companies not authorized by Genentech, although it's unclear at this point where those distributors came by their supplies.

So far, the company's testing has shown the counterfeit vials contain none of Avastin's active ingredient. Just what they do contain hasn't yet been determined, The Wall Street Journal reports. "We are working with the FDA and law enforcement to aid their evaluations, determine the source of the counterfeit drug, and prevent its further distribution," Roche and Genentech said in a statement. "The counterfeit product is not safe or effective and should not be used."

The FDA says it notified 19 medical practices about the phony Avastin vials, which can be identified by several differences on the label. The counterfeit label is in French, with lot numbers beginning with a letter. They're also labeled "Roche," while the genuine drug carries a Genentech label.

Counterfeit drugs are typically associated with online pharmacies and developing countries, where regulation and controls can be less stringent. In the U.S., the WSJ points out, hospitals and pharmacies typically source their drugs through authorized distributors that buy directly from manufacturers. The FDA letters identified the suppliers of suspect Avastin as Quality Specialty Products, also known as Montana Health Care Solutions, and its distributor Volunteer Distribution, the Journal said. Neither company was reached for comment; Genentech said the companies weren't authorized to sell Avastin.

- see the news from Reuters
- read the WSJ article

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