Sen. Brown to assess FDA 'fast track' designation

WASHINGTON Sen. Sherrod Brown, D-Ohio, has asked Congress for information on the Fast Track designation to help determine whether the program should be changed or eliminated completely, according to published reports. Fast Track was intended to speed up the availability of drugs for serious diseases.

Brown discovered that the designation has done little to benefit consumers and is more of a benefit to investors, who use it as a way to make quick money in the stock market.

Brown said the research will cover the various FDA programs to develop and review drugs and will help provide an assessment of Fast Track’s impact in preparation for discussions with Senate colleague Edward Kennedy, a Massachusetts Democrat. Congress approved the Fast Track designation in 1997 as part of extensive legislation to streamline the system for approving drugs and medical devices.

Kennedy tried to support the designation by stating, “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. 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 top FDA official acknowledged that Fast Track gives drug companies access to the same programs that were in place before the designation and provides no unique benefits to speed the development and approval of drugs.