NEW: Coalition Lawsuit Halts Dangerous ‘Sunset Rule’

Trump-Era ‘Time Bomb’ Would Automatically Scrap ~18k Regulations Affecting Everything from Healthcare, Vaccination Programs to Baby Formula and Drug Safety

In response to a recent lawsuit filed by local government, associations, and non-profit organizations, the U.S. Department of Health and Human Services (HHS) issued a one-year stay of the effective date of the unlawful “Sunset Rule,” which would have added automatic expiration dates to more than 18,000 regulations issued by HHS and its sub-agencies. HHS filed the stay in the Federal Register on March 18, 2021. Had the Sunset Rule gone into effect as planned on March 22, 2021, the rule — proposed and finalized in the Trump administration’s lame-duck period — would have set a ticking time bomb on thousands of crucial HHS regulations.

In response, the Plaintiffs issued the following joint statement:

“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.”

In issuing this stay of the effective date, HHS:

  • Wrote that the “interests of justice require a postponement in order to preserve the status quo, because, if the rule took effect while HHS was evaluating the rule in light of the claims raised in litigation, it could create significant obligations for HHS, cause confusion for the public, including Plaintiffs...” 
  • Found that the uncertainty caused by the rule “could have serious implications for insurance markets, hospitals, physicians, and patients, among other affected parties,” and
  • Determined that allowing the rule to take effect would require HHS and the Food and Drug Administration “to immediately divert resources … during the ongoing COVID-19 public health emergency,” significantly impacting “actions to address urgent public health matters such as ongoing COVID-19 pandemic relief efforts, outbreaks of foodborne illness, inspections, recalls, and other public health priorities.”

Without time- and resource-intensive departmental review, roughly 17,200 regulations would automatically be eliminated in 2026, with more regulations terminating thereafter. 

In its notice, HHS went further:

  • Writing that “HHS now believes that it is likely some regulations would expire without any additional administrative process (contrary to the conclusions reached in the SUNSET final rule),” that “based on HHS’s initial review of the Complaint, HHS believes that the Court could find merit in some of Plaintiffs’ claims,” and that “Plaintiffs’ allegations of harm are credible”; and  
  • Acknowledging that the lawsuit calls into question whether the rule is “consistent with the policies and goals of the current administration, both in terms of the appropriate role of regulatory oversight of the health care industry and necessary engagement with the public, including tribal organizations.” 

The County of Santa Clara, the California Tribal Families Coalition (CTFC), the National Association of Pediatric Nurse Practitioners (NAPNAP), the American Lung Association, the Center for Science in the Public Interest (CSPI), and NRDC (Natural Resources Defense Council) filed a lawsuit over the Sunset Rule on March 9 in the U.S. District Court for the Northern District of California. Democracy Forward is litigating the case as counsel for all Plaintiffs, alongside legal teams from the County of Santa Clara, NRDC, and CSPI. 

Read the complaint in full here. Learn more about the lawsuit here.

For more information, contact:

Allison MacMunn
312-801-7628
[email protected]

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