Sen. Brown Requests Information On FDA Fast-Track Designation

Main Category: Public Health
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 15 Jan 2008 - 6:00 PDT

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

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

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Brown said, "We'll have a better understanding then, when I go to Kennedy and his people to talk about this," adding, "They can see what they want to do then." Kennedy in a statement said, "Fast-track designation is meant to speed the review of urgently needed medicines, and it should not be abused to artificially inflate a company's profits," adding, "Congress should see that the fast-track process is not abused and retains its intended purpose of seeing that important new medicines reach the patients who need them without undue delay" (Rutchick/Zeltner, Cleveland Plain Dealer, 1/10).

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