Sen. Sherrod Brown (D-OH) has asked the CongressionalResearch Service for information on the FDA’s Fast Track designation for somedrugs seeking NDA approval to see if it would make sense to eliminate theprocess.
Brown told the Cleveland Plain Dealer the research willcover the various FDA programs to develop and review drugs and will provide anassessment of the Fast Track’s impact. He said he plans to discuss the findingswith Edward Kennedy (D-MA), one of the architects of the Fast Track process 10years ago.
A Kennedy spokesperson told the newspaper that patient groupshad advocated for the designation and the senator supported it because peoplewere “suffering and dying needlessly.” The spokesperson said that if profitingon company stock has been an unintended consequence of Fast Track, Congressshould change it.
“Fast Track designation is meant to speed the review ofurgently needed medicines, and it should not be abused to artificially inflatea company’s profits,” Kennedy said in a statement released to the Plain Dealer.“Congress should see that the Fast Track process is not abused and retains itsintended purpose of seeing that important new medicines reach the patients whoneed them without undue delay.”
A Plain Dealer analysisreported that the designation provides little actual benefit to consumers butrather has been a drug company marketing tool and a boon for investors.
From the March 01, 2008 Issue of MM+M - Medical Marketing and Media
