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The FDA cowtows further to "big pharma"

When drugs are approved for sale in the U.S., the high-intensity marketing campaigns are limited to selling the drug for the approved purposes only:  manufacturers' sales representatives are not allowed to push the drug for non-approved uses.  In another example of what large contributions can achieve with the Bush Administration, the FDA is now seeking to change this decades-old rule.

The FDA is pressing a rule change that would allow the ubiquitious drug reps to provide doctors with articles that discuss non-approved uses.  The manufacturers and their sales people would not have to promise to adequately test the unapproved use discussed in the article.  Critics of the proposal note that pharmaceutical companies have a long history of pushing medications for non-approved uses in a manner that has later turned out to be dangerous. 

Previous blog entries have discussed this very phenomenon with regard to a drug approved only for severe psoriasis.  The New York Times reports that in 2004, Pfizer paid a $430 million dollar fine to resolve criminal and civil charges arising out of its marketing of Neurontin.  Critics also note that the rule change elminates any incentive for drug companies to adequately test or research secondary drug usages.  Dr. Steven Nissen of the Cleveland Clinic told the Times "I'm astonished that this rule would even be considered."

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