On May 27, 2022, the U.S. Department of Health and Human Services (HHS) issued a final rule withdrawing the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule, which had been promulgated in the waning days of the Trump administration and would have required most rules administered by HHS to be reviewed within 5 years of the effective date of the SUNSET rule, and then every 10 years thereafter, or else be automatically repealed. As we have previously blogged about, HHS proposed withdrawing the SUNSET rule in a proposed rule issued on October 29, 2021.

Reiterating many of the points made in the October proposed rule, HHS justified the withdrawal because (1) the initial analysis of the rule was inaccurate and, among other things, significantly understated the resources that implementation of the SUNSET rule would consume, and the more realistic estimate would have prevented HHS from carrying out its statutory obligations and mission to protect public health; (2) the rule violated the Administrative Procedure Act (APA), including by being issued without sufficient opportunity for comment and by allowing for rules to be revoked without notice or evaluation of their importance; and (3) the rule was contrary to the policies of the Biden administration, which seeks to use the regulatory authorities of administrative agencies to confront the challenges facing the country.

The vast and continuing nature of the regulatory review contemplated by the SUNSET rule is unworkable and its withdrawal comes as no surprise. Indeed, even without a withdrawal, it is doubtful that the rule would have withstood legal challenge. Nevertheless, as HHS noted in the withdrawal, consistent with its obligations under the Regulatory Flexibility Act (RFA), HHS does already conduct certain more limited retrospective reviews of regulations.