HHS Regulatory Reform Proposal Seen As Blunt Instrument That Could Burden Industry and Agencies

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.

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The US Department of Health and Human Services issued a proposed rule on 4 November that would lead to the automatic expiration of most Food and Drug Administration and Centers for Medicare and Medicaid regulations 10 years after their first issuance unless the agency undertakes a required assessment and review process.

Legal experts say the proposed rule, if finalized, could ironically create a lot of work for the agencies in the name of limiting unnecessary government. This is particularly true for FDA, they say, where it is unlikely the agency, industry and public health groups would be eager to make many regulatory changes

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