FDA Drug User Free Act: adding "comparative effectiveness" tests will not help consumers

FOR IMMEDIATE PRESS RELEASE: June 16, 2011

In a just released AEI Health Policy Outlook, AEI scholar Scott Gottlieb, M.D. argues that adding a new mandatory "comparative effectiveness" test to the approval process for new drugs in the reauthorization of the Food and Drug Administration (FDA) Prescription Drug User Fee Act constitutes a needless waste of time and money.
Among the key points:

  • Consumer groups are pushing to add a step to the FDA drug approval process: "comparator" trials, which test a new drug against the current standard treatment.
  • But these trials are already being conducted where it really matters. A new FDA approval requirement would unnecessarily slow down the approval process for all other drugs.
  • Achieving the goal consumer groups want--safer and more cost-effective drugs--requires innovation in clinical trial design, not a congressional mandate.

Scott Gottlieb is available for interviews and can be reached at scott.gottlieb@aei.org or through his assistant gabriel.sudduth@aei.org

(202.862.7183).

 

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