Healthy Skepticism Library item: 2174

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Publication type: news

Adams C.
Glaxo Gets FDA Warning Letter On Improper Avandia Marketing
The Wall Street Journal 2001 Aug 2
http://online.wsj.com/article/SB996704760327413423.html?mod=googlewsj#printMode

Full text:

WASHINGTON — The Food and Drug Administration is stepping up action against GlaxoSmithKline PLC over improper marketing of its popular diabetes drug Avandia.

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 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 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.

At an American Association of Clinical Endocrinologists meeting in May, the FDA said Glaxo representatives were heard discussing the safety profile of Avandia. Even though the drug’s official label was recently changed to reflect new cardiac-related safety concerns, a Glaxo sales representative said there had been no such change, according to the FDA. The next day, a different sales representative said the same thing, the FDA said.

“These statements are clearly inconsistent with Avandia’s labeling change,” the FDA wrote the company. “Indeed, not only did your representatives fail to disclose the important new risks . they actually denied that any changes to the Avandia [label] had occurred and stated that they were not aware of any new risks” concerning heart failure.

Glaxo spokeswoman Karen Collins said the company is “working closely with the FDA” regarding the letter. She said the company has “taken the appropriate corrective steps” regarding its sales representatives, but didn’t elaborate. “We are taking this situation very seriously,” Ms. Collins said.

The TV ad was cited by the FDA as misleading because it failed to present certain risk information. The FDA said the ad also presented certain risk information in a confusing manner. Glaxo said it pulled the ad to make changes and has since begun running a corrected version.

Write to Chris Adams at chris.adams@wsj.com