HHS seeks to pull Trump-era 'ticking timebomb' rule that would've put 95% of FDA regulations on the chopping block
The HHS is proposing to withdraw a Trump-era final rule that would have sunset thousands of FDA and other public health agency rules based on how long they’ve been in place.
The decision follows the filing of a lawsuit last March, in which several nonprofits alleged: “The outgoing administration planted a ticking timebomb set to go off in five years unless the HHS, beginning right now, devotes an enormous amount of resources to an unprecedented and infeasible task.”
That task for the FDA, according to the HHS, would be to review 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. The HHS also previously delayed the start of the Trump rule so that critical resources weren’t diverted away from the pandemic to the review of federal regulations.
The HHS said Friday that, overall, pulling the rule will save it more than $900 million over the next decade, and added significant details on the ways in which former HHS Secretary Alex Azar’s previous final rule was flawed:
Our thinking is informed by a reevaluation of the factual premises and conclusions in the SUNSET final rule that are central to the Department’s analysis of the rule’s implications and effects. In particular, based on a reanalysis of the regulatory impact of the rule, we now believe that the rule likely rested on a flawed understanding of the resources required for this undertaking, which implicates the likelihood that HHS regulations would expire, and which in turn will require the Department to make resource allocation decisions which could impede the Department’s ability to carry out other key priorities. That diversion of resources will likely impede efforts to adopt new rules to address national priorities and advance equity for all, including historically underserved and marginalized communities. It is therefore potentially inconsistent with the current Administration’s policies that aim to empower agencies to use appropriate tools to achieve those ends.