HHS Regulatory Reform Proposal Seen As Blunt Instrument That Could Burden Industry and Agencies
Executive Summary
Most FDA and CMS rules would sunset after 10 years unless action is taken by the agency under a new HHS proposed rule designed to enforce retrospective regulation review. Some experts worry this could allow an administration to skirt traditional notice and comment periods before rule rescissions. The implementation of the rule would likely look very different at FDA than at CMS, experts added.
You may also be interested in...
Some Long-Standing FDA Regs Face Mandatory Review Or Rescission Under New HHS Rule
Among those judged eligible are FDA rules governing adverse event reporting and the Unique Device Identification System.
White House Advances War On 'Guidance'; FDA Not Target, But May Feel Ripple Effects
US FDA's efforts to enforce against regenerative medicine and other gray market products might be collateral damage in Trump administration's latest attack on the perceived abuse of powers by regulatory agencies.
US FDA Likely Not 'Significant', Could Be Mostly Spared From Trump's Regulation-Slashing Order
But even though executive order that requires regulatory off sets may only have limited application to FDA, limited, experts warn that it still could prove extremely unwieldly to implement.