Effects of approval delays on public health should be measured by FDA -- Rep. McIntosh.
This article was originally published in The Gray Sheet
Executive Summary
EFFECT OF FDA APPROVAL DELAYS ON PUBLIC HEALTH SHOULD BE MEASURED by the agency, Rep. David McIntosh (R-Ind.) said Sept. 14 at a joint hearing of the House Government Reform Committee's Human Resources and National Economic Growth Subcommittees. McIntosh, who chairs the latter subcommittee, suggested that FDA should develop a mechanism to calculate "how many lives were lost and what the [other] downsides were to" delays in the approval process. Eventually, he added, the agency would have a "body of information" that could be used in an effort to balance the need between keeping unsafe devices off the market and speeding devices with a significant potential to save lives onto the market.
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