HHS finishes off Trump-era rule that would've erased basic FDA regs without frequent reviews
HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.
The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.
“The SUNSET final rule, if implemented, would have significantly altered the operations of HHS with considerable negative repercussions for a diverse array of stakeholders,” the final withdrawal posting on Thursday said. “We now conclude that these significant repercussions were not adequately considered in issuing the SUNSET final rule in part because the process to promulgate the rule was extremely unusual, if not unprecedented.”
As far as the ongoing litigation, HHS added, “At the parties’ joint request, the Santa Clara litigation has thus far been stayed.”
Had this withdrawal of the SUNSET rule not gone through, the FDA, according to HHS, would have faced the massive task of reviewing over 7,000 sections of the CFR that were promulgated by the agency and which are more than 10 years old or would become more than 10 years old during the first five years the rule would be in effect, representing over 95% of the FDA’s current regulations.
And the final rule provides no exceptions to avert the expiration of a regulation if it’s not reviewed, even in the event of a pandemic, a public health emergency, or another declared national emergency.
FDA and HHS also explain how they regularly review their regulations, particularly for FDA in response to certain citizen petitions.
“It should be noted at the outset that HHS recognizes the importance of retrospective review, already conducts retrospective reviews, and intends to continue to consider how to improve these existing processes,” the department said in the Federal Register on Thursday.
The FDA also maintains a website containing its economic impact analyses of FDA regulations, with links to at least 170 regulatory impact analyses the agency has developed since 2012.
And the SUNSET rule would’ve been tough on the entities covered by the regulations too, the withdrawal notice from HHS says.
“For example, one commenter expressed concern that if the SUNSET final rule is not withdrawn, their advocacy organization would need to redirect resources to monitor the status of the approximately 2,000 FDA regulations and then, if needed, invest at least 40 to 100 hours per rule to provide comments,” HHS said. “The actual expiration of regulations could lead to confusion among stakeholders and undermine predictability and confidence in many sectors regulated by the Department.”