GUEST EDITORIAL
By Thomas Cheplick, The Heartland Institute
The Food and Drug Administration has issued a guidance document detailing a possible new regulation against off-label use of a category of medical devices, a development that stunned the device industry.
The new FDA regulation would extend the legal doctrine called “intended use” to cover manufacturers of medical devices and make those manufacturers legally liable for off-label uses of their products.
The FDA’s decision could have profound and deadly consequences for individuals’ health and decimate the medical device industry, says Paul Citron, a founding member of the American Institute for Medical and Biological Engineering. Under the proposed new regulation, if a doctor used a medical device in a way that the label did not suggest, the manufacturer of the device could be held liable.
Clampdown on Physicians
Citron says he is aghast at what the FDA is attempting to do.
Innovation in device use “would become legally much more difficult to do if the FDA succeeds in their new regulation of medical device manufacturers,” Citron said. “In fact, many medical devices that Americans benefit from in helping them cope with a specific ailment were found to help with those ailments through off-label use—in part because physicians are a self-regulating, communicating body.”
Citron cites the clinical defibrillator as a case in which a medical device was used in an off-label way that then became the on-label way.
Republished with permission from The Heartland Institute
