HHS hits pause on Trump era SUNSET rule

Regulatory NewsRegulatory News
| 22 March 2021 | By Michael Mezher 

The US Department of Health and Human Services (HHS) is postponing the implementation of a controversial Trump era rule that would have required the department to review thousands of its regulations while the rule undergoes judicial review.
The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) was first proposed in November 2020 and finalized on 19 January 2021, one day before President Joe Biden’s inauguration. At its core, the rule would sunset most HHS regulations after 10 years if they are not assessed and reviewed based on criteria set out in the Regulatory Flexibility Act and requires HHS to review nearly all its regulations within five years. (RELATED: HHS pushes through last-minute policies impacting FDA, Regulatory Focus 12 January 2021).
The rule also allows the HHS secretary to extend the review the deadline for regulations by up to one year and requires the department to publish monthly lists of the assessments and reviews it has begun for public comment.
Earlier this month, the County of Santa Clara, California, and a coalition of health groups sued HHS in the US District Court for the Northern District of California under the Administrative Procedures Act seeking to invalidate the rule, calling it “rushed” and “arbitrary and capricious.”
In a Federal Register notice on Friday, HHS said it is delaying the implementation of the rule by one year while the court considers the case and that, based on its own review of the rule, the court “could find merit in some of Plaintiffs’ claims.”
“HHS finds that the interest of justice require that the SUNSET final rule’s effective date be postponed pending judicial review because: based on HHS’s initial review of the Compliant, HHS believes that the Court could find merit in some of Plaintiffs’ claims; Plaintiffs’ allegations of harm are credible; a postponement will permit HHS to review the SUNSET final rule in light of the claims raised in the litigation; and the balance of equities and the public interest warrant postponement of the effective date to preserve the status quo while the Court considers the challenge to the SUNSET final rule,” HHS writes.
While HHS is “taking a fresh and critical look at the SUNSET final rule in light of the allegations in the Complaint,” the department said it “does not concede” any of the claims made in the case at this time.
However, HHS does raise concerns about the rule and said that it now believes that were the rule to be implemented that some regulations would expire without undergoing any sort of administrative process.
“That outcome could raise interrelated administrative law questions regarding: whether regulations promulgated through notice and comment rulemaking can be terminated through an umbrella rule without individualized consideration of the expiring regulations, including any reliance interests of parties affected by them; and, if so, whether the proposed/final rule provided an adequate justification for implementing a process of automatic expiration,” HHS writes.
For FDA specifically, HHS points out that more than 7,000 sections of the Code of Federal Regulations promulgated by FDA are more than 10 years old or would become more than 10 years old during the first five years the rule would be in place. This represents more than 95% of the agency’s current regulations and would be a massive undertaking to assess and review within five years. To do so, “FDA and the Department would need to immediately divert resources toward assessment and review during the ongoing COVID-19 public health emergency,” HHS writes, adding that the effort would likely upend FDA’s ability to meet its public health mandate and user fee commitments.
“The Sunset Rule would spark regulatory chaos as thousands of critical HHS regulations face automatic elimination in just a few years’ time. The regulations affect everything from the healthcare system and public health measures to food safety protocols and social services. We commend the Biden-Harris administration for halting this unlawful rule that would eliminate thousands of critical health and food safety protections. We’re continuing our legal fight to ensure the Sunset Rule never goes into effect,” the plaintiffs said in a joint statement on Friday.


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Tags: FDA, HHS, SUNSET rule, US

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