21st Century Cures Act May Do More Harm Than Good
July 22nd, 2015 by Cutter Law
“would make it possible for companies that produce high-risk medical devices to submit evidence of safety and efficacy based on sources other than clinical trials, including case histories (i.e., the experiences of individual patients). In other words, anecdotal evidence, rather than the scientific studies, could be used to approve devices.
This act would also create a new, faster approval process for “breakthrough technologies” that are believed — but not necessarily proved — to offer significant advantages over existing alternatives. This would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk. The legislation defines “breakthrough” loosely, creating a perverse incentive for manufacturers to use this term both to take advantage of the faster approval process and as a marketing gimmick.”
“found that patients who had the device implanted were more likely to have another stroke and to die than those just receiving medical management. Despite this evidence, the F.D.A. did not withdraw the device (though it did narrow its recommended uses). The Wingspan continues to be marketed and implanted today, putting patients at unnecessary risk.”
“There’s a misperception that you might be able to speed up innovation by lowering the standards for safety and efficacy, and I think that would be a terrible mistake that would not only just damage patients, but industry as well.”
- Dr. Jerry Avorn and Dr. Aaron Kesselheim in the New England Journal of Medicine: The 21st Century Cures Act — Will It Take Us Back in Time?
- The New York Times Editorial Board: How Not to Fix the FDA
- Letter to the US House of Representatives from the National Physician Alliance and seven other organizations
- Statement from Dr Diana Zuckerman, President of the National Center for Health Research
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