Friday, July 16, 2010

FDA Panel Doles Out Bad Medicine For Lobbying Heavyweight GlaxoSmithKline

By Andrew Kreighbaum on July 14, 2010 4:44 PM 

A 33-member advisory panel to the federal Food and Drug Administration voted today to seriously restrict the labeling and possibly the sale of the controversial diabetes drug Avandia, the New York Times reports. The FDA will consider this recommendation when it makes its final ruling at a later date.

A negative FDA ruling will likely affect the bottom line of a company that spent $8.7 million on federal lobbying in 2009 and has already spent $2.2 million in the first quarter of this year.GlaxoSmithKline, the drug's manufacturer, has much more than that at stake. It earned $1.1 billion from the drug in 2009, Fortune reports.

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A 2006 article in the New England Journal of Medicine said that patients taking Avandia had a much greater risk of heart disease than patients on alternative drugs.

A ruling that pulled the drug from the market could result in more litigation against GlaxoSmithKline, Fortune reported, but the drug accounts for only 2 percent of the company's profits.

GlaxoSmithKline is a major political player in Washington and ranks seventh for lobbying expenditures among all pharmaceutical and health product companies this year.

Lobbyists for the drug-maker have lobbied both the House and Senate during the first three months of 2010, but have not reported lobbying the FDA between January and March. Reports for lobbying performed between April and June are due out next week.

Overall, more than 240 companies and groups lobbied the FDA during the first quarter.

And the pharmaceutical industry as a whole spent $69 million on lobbying during the first quarter, putting it on pace to match its record 2009 expenditures.

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