Sen. Brown Requests Information On FDA Fast-Track Designation

Armen Hareyan's picture

Sen. Sherrod Brown (D-Ohio)last week filed a request with the CongressionalResearch Servicefor more information on the fast-track designation that FDA awardsto reduce review times for new medications for serious diseases, the Cleveland Plain Dealer reports. Last month, the PlainDealer published a series of articles based on a seven-monthinvestigation on the fast-track designation and "concluded the designation... provides little actual benefit to consumers" and "has amounted toa government blessing ... for drug companies and a boon for investors lookingto make quick money on the stock market."


Brown requested the information in preparation for meetings with Sen. EdwardKennedy (D-Mass.), chair of the Senate Health,Education, Labor and Pensions Committee, to decide whether lawmakers should revise oreliminate the fast-track designation, which Congress established in 1997.


Brown said, "We'llhave a better understanding then, when I go to Kennedy and his people to talkabout this," adding, "They can see what they want to do then."Kennedy in a statement said, "Fast-track designation is meant to speed thereview of urgently needed medicines, and it should not be abused toartificially inflate a company's profits," adding, "Congress shouldsee that the fast-track process is not abused and retains its intended purposeof seeing that important new medicines reach the patients who need them withoutundue delay" (Rutchick/Zeltner, Cleveland Plain Dealer,1/10).

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