"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..."
