Retiring Rep. Dingell’s Health Policy Legacy Included Fierce Oversight Of Device Center
This article was originally published in The Gray Sheet
A powerful former Chairman of the House Energy and Commerce Committee, Dingell has not been only a major player in the health care reform fight, but also a vigorous prober of FDA, launching investigations with lasting effects on the device center. The longest-serving member of the House announced his plans to retire at the end of this congressional term.
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Former House Energy and Commerce Committee Chairman John Dingell Jr., D-Mich., who was a fierce investigator of federal agencies including US FDA and sponsor of the Affordable Care Act and other legislation impacting the device industry, died at age 92 Thursday at his home in Dearborn, Mich.
FDA may have had legitimate concerns that confidential commercial information on a GE Healthcare 510(k) submission were released in 2010 by CDRH scientists, but the agency’s computer monitoring strategy lacked sufficient controls, and may have gone beyond legal bounds, suggests the HHS Office of Inspector General. The agency issued a new interim monitoring policy last September that addresses OIG’s recommendations.
In a report to Congress, FDA stuck with device industry recommendations to merely revise its 1997 guidance on 510(k) device modifications, rather than to more thoroughly revamp the policy.