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March 24, 2008

FDA Relaxing Oversight of Drug Companies?

Drug companies have sales representatives who make calls on doctors to meet with them about the drugs that their company makes and give them information about the benefits of the drugs in order to increase sales.  Currently, the law requires that the drug representative only discuss uses of the drugs that have been approved by the FDA.  The FDA has now announced that it is considering relaxing this law.  The FDA is considering allowing the drug companies to distribute marketing about drugs directly to doctors relating to uses for which the drugs have not received FDA approval.   To read an opinion article by a professor and department head from Duke University click here.  This idea sounds like having the fox guard the hen house.  The reason for the FDA approval process, as weak as it is, is that the FDA reviews the available science and research and approves a drug for certain uses.  This proposal would allow the drug company to determine what was an appropriate "off-label" use and market that use directly to doctors without any FDA involvement.  This is a step too far and hopefully the FDA will receive enough negative comments during the public comment period that it will see the error of this misguided plan. 

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