On March 18, 2021, the Department of Health and Human Services announced via public inspection a one-year delay of the rule’s effective date to March 22, 2022 in order to review the rule in light of pending litigation and stated the following: “The SUNSET final rule was scheduled to take effect on March 22, 2021. On March 9, 2021, a lawsuit was filed seeking to overturn the SUNSET final rule. HHS finds that the interests 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 Complaint, 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."

The Department of Health and Human Services (HHS) recently finalized a department-wide rule adding sunset provisions to thousands of public health and welfare regulations, including those made and enforced by the FDA. Despite widespread opposition to the proposed rule and denial of the numerous requests for additional time to weigh in, the rule was finalized with limited changes just days after the comment period expired. 

Summary of the Rule

The final rule establishes a system for retrospective review of regulations by HHS and its subagencies and broadly imposes sunset provisions across those regulations with limited exceptions.

Under the rule, many HHS regulations will automatically roll back unless the Department or relevant subagency performs certain regulatory review activities to determine whether regulations may be modified to be less economically burdensome and accomplish the same goals. The rule establishes sunset dates that would be the latest of: (1) five years after the SUNSET rule first becomes effective, (2) ten years after the regulation was established, or (3) ten years after the last time the rule was reassessed under these new requirements.

Anticipated Public Health Impacts of the Rule

Many commenters, including Public Health Law Center, expressed strong opposition to the proposed rule because it creates substantial uncertainty in public health and welfare regulation and establishes burdensome, agency-wide changes at a time when the country is confronting a national public health crisis in the COVID-19 pandemic. Diverting agency resources from the pandemic response and other pressing public health concerns in order to implement a new, retrospective review scheme raises concerns about timely progress on important public health priorities. The change will also require public health advocates to track regulations to ensure they do not inadvertently expire for lack of agency review, wasting advocacy resources.

Looking Ahead: Legal Strategies for Removal

The immediate future of the SUNSET rule is uncertain due to several factors. It is possible that the rule may be withdrawn by HHS due to a significant shift in administrative priorities; revoked by Congress due to agency overreach and frustration of congressional intent; or challenged in litigation for violating the Administrative Procedure Act.

• HHS could reconsider or withdraw the rule in light of concerns regarding both the legality of the final rule and the authority of HHS to finalize the rule. A decision to reconsider or withdraw would align with the recent executive branch directive that all agencies initiate a regulatory freeze in order to review issues of fact, law, and policy raised by pending rules. A decision to hold off on instituting a new regulatory review scheme would also align with the purpose of another recent executive branch directive that all agencies participate in developing recommendations for modernizing regulatory review. This directive specifically states the importance of public engagement in the process and that “recommendations should provide concrete suggestions on how the regulatory review process can promote public health and safety, economic growth, social welfare, racial justice, environmental stewardship, human dignity, equity, and the interests of future generations.”
• Congress could also decide to invoke the Congressional Review Act to overturn the HHS rule. Under the Congressional Review Act, Congress has the authority to overturn agency rulemaking within a review window by passing a joint resolution of disapproval that is approved by the president. If a rule is overturned through this process, the agency is prohibited from enacting substantially similar rules in the future.
• Litigation challenging the rule under the Administrative Procedure Act is also possible. The APA outlines specific requirements for agency procedure, including public notice and comment, requires agencies to provide a satisfactory explanation for its action, and requires agencies to consider all important aspects of the problems they seek to address. Multiple commenters, including Public Health Law Center, raised concerns that the rule did not involve individualized consideration and review of the regulations that would be subject to the new sunset provisions. Further, future regulations that expire under the sunset provisions would lack any agency explanation for the decision, would fail to consider any relevant factors, and deny the public any opportunity for comment.

The Public Health Law Center will track developments relating to the rule’s implementation and continue to provide updates and analysis.

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Read Public Health Law Center’s public comment urging HHS to abandon the proposed rule.

By Rebecca Hare, Attorney Fellow
February 3, 2021