MASSDEVICE ON CALL — Former FDA commissioner Andrew von Eschenbach turned heads yesterday by calling on the federal watchdog agency to abandon efficacy testing when considering new drug and device applications.
Eschenbach, who led the agency from 2006 to 2009, called for an overhaul of the FDA’s mission statement and urged Congress to leverage user fee negotiations to reassess the agency’s performance.
"The United States has the world’s most innovative drug and device companies and research universities, plus the unparalleled National Institutes of Health," Eschenbach wrote in an op-ed for the Wall Street Journal. "What’s missing is a modernized Food and Drug Administration that can rapidly and efficiently bring new discoveries to patients."
Eschenbach is currently chairman of the conservative think tank the Manhattan Institute for Policy Research, where he heads "Project FDA."
Cutting efficiency standards from the review process isn’t likely to be a popular move among patient advocacy groups, but medical device makers may not find it so alluring either.
Lowering standards for FDA clearance may make the industry more vulnerable to lawsuits, MedCity News reported.
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