Probe into FDA's 'fast track' program
Sen. Sherrod Brown (D-OH) has asked the Congressional Research Service for information on the FDA's Fast Track designation for some drugs seeking NDA approval to see if it would make sense to eliminate the process.
Brown told the Cleveland Plain Dealer the research will cover the various FDA programs to develop and review drugs and will provide an assessment of the Fast Track's impact. He said he plans to discuss the findings with Edward Kennedy (D-MA), one of the architects of the Fast Track process 10 years ago.
A Kennedy spokesperson told the newspaper that patient groups had advocated for the designation and the senator supported it because people were “suffering and dying needlessly.” The spokesperson said that if profiting on company stock has been an unintended consequence of Fast Track, Congress should change it.
“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,” Kennedy said in a statement released to the Plain Dealer. “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.”A Plain Dealer analysis reported that the designation provides little actual benefit to consumers but rather has been a drug company marketing tool and a boon for investors.