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 [email protected] or through his assistant [email protected]

(202.862.7183).

 

Also Visit
AEIdeas Blog The American Magazine

What's new on AEI

Retirement crisis is hyped
image Why the Foley beheading will force Obama to continue US airstrikes
image How the New York Times misguides their readers on Internet regulation
image US still has time to stake out a position of strength on Ukraine
AEI on Facebook
Events Calendar
  • 18
    MON
  • 19
    TUE
  • 20
    WED
  • 21
    THU
  • 22
    FRI
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled today.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.