FDA Should Not Mandate Comparative-Effectiveness Trials

"Consumer groups are pushing for a new drug approval mandate that would require drug companies to conduct "comparative effectiveness" trials to win Food and Drug Administration (FDA) approval for new medicines.  Proponents of this policy argue that new drugs should have to prove superior to older medicines to gain marketing approval.  These requirements would add a major hurdle to the development and approval of new medicines, adding significant time and cost, says Scott Gottlieb, M.D. and a resident fellow at American Enterprise Institute.

• 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 in important cases; a new FDA approval requirement would slow down the drug approval process elsewhere.
• If such an FDA mandate were adopted, the resulting studies would likely be "noninferiority trials," which are unlikely to conclusively show whether a new medicine is indeed more effective than an existing alternative.
• Achieving the goal consumer groups want -- safer and more cost-effective drugs -- requires innovation in clinical trial design, not a congressional mandate.

The market already demands that a new drug show that it is superior to an older, often cheaper alternative..."