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
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
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.