AdvaMed prez & CEO Scott Whitaker shot back at a New York Times op-ed published earlier this month pushing for tighter FDA regulations, calling the federal watchdog “the gold standard the world over” while avoiding commenting on any of the issues raised in the original piece.
Last week, the Times cited a number controversial devices that have recently made headlines for deaths and adverse events associated with their use, supporting a call for the abolishment of the 510(k) pathway and tighter oversight from the agency.
In his response, also published by the New York Times, Whitaker touted that “countless lives worldwide had been saved and improved thanks to hundreds of thousands of safe, effective medical devices approved through a stringent process by the [FDA].”
Whitaker did not touch on any of the issues brought up in the original op-ed, instead offering that “no intervention to alleviate suffering is 100% risk-free” and adding that “studies” show a 99.5% freedom from serious recalls in low to moderate-risk devices, though he did not provide any references to the studies mentioned.
“F.D.A. oversight is the gold standard the world over, and every device is subject to strict pre- and post-market oversight. Suggesting otherwise could needlessly alarm patients, perhaps to the point of questioning clearly safe and effective devices,” Whitaker wrote in the Times-published opinion response. “We recognize that no regulatory system is perfect and continually work with the F.D.A. and other stakeholders to ensure that devices are safe and effective. This further enhances an already robust process to achieve our common goal of improving patients’ lives.”
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