FDA Should Not Mandate Comparative-Effectiveness Trials
June 21, 2011
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. Drug companies routinely pursue superiority trials to secure reimbursement when their drugs are destined to compete with ostensibly similar but cheaper alternatives. In other cases, where public health prerogatives obligate new drugs to prove equal to or better than existing medicines, the FDA already uses its considerable latitude to demand noninferiority trials, and in some rarer cases, superiority trials. In short, comparative trials are already getting done where it most counts, says Gottlieb.
Source: Scott Gottlieb, "The FDA Should Not Mandate Comparative-Effectiveness Trials," American Enterprise Institute, June 15, 2011.
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