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Glaxo Gets FDA Warning Letter

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WASHINGTON -- The Food and Drug Administration is stepping up action against GlaxoSmithKline PLC over improper marketing of its popular diabetes drug Avandia, Thursday's Wall Street Journal reported.

In a formal warning letter dated July 17, the FDA said it had learned that the company's sales representatives, speaking with doctors at a recent medical conference, denied the existence of serious side effects Avandia users may experience. In a separate letter, the agency also told the company to stop airing a "misleading" television ad for Avandia.

All told, Avandia has been singled out five times since 1999 for improper, misleading, or false marketing, leading to the FDA's relatively unusual warning letter last month. While the FDA sends out dozens of routine citations, it issues only a handful of the more-serious warning letters each year.

The FDA chided Glaxo (GSK) for the "seriousness of your violations" and "the fact that violative promotion of Avandia has continued despite your written assurances" that it would stop. The agency told Glaxo to write any doctor who was or may have been exposed to the improper statements to correct the record.
Avandia, used by patients with the most common form of diabetes -- known as "type 2," or sometimes "adult onset," diabetes -- is in a hotly competitive struggle with rival drug Actos, marketed by Japan's Takeda Chemical Industries Ltd. and Indianapolis-based Eli Lilly&Co. Avandia sales were $534 million in the first six months of 2001.

The warning letter is part of an effort by the FDA's Division of Drug Marketing, Advertising and Communications to step up enforcement of the exhibit booths that drug companies set up at major medical conferences.

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