Former FDA Policy Chief Says Consumer Group Request Would Slow Drug Approvals

June 16, 2011 – The Food and Drug Administration (FDA) should not mandate comparative effectiveness trials as part of the drug approval process, according to Scott Gottleib, a resident fellow with the American Enterprise Institute for Public Policy Research (AEI).

Gottleib, a former FDA policy head, writes in AEI’s June issue of Health Policy Outlook that the FDA should not bow to the pressure of consumer groups that are calling for across-the-board comparative effectiveness trials be added to the drug approval process, noting that these trials already are being conducted in important cases. Requiring these trials for all drugs would significantly slow down drug approval reviews, he asserts in the article. Read the full AEI Guest Column.

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