HHS postpones review of over 95% of FDA’s regulations so critical resources are not diverted from Covid-19
The Department of Health and Human Services said late Thursday that it’s postponing a last-minute rule enacted by former President Trump’s HHS that would’ve required the FDA to review almost every one of its regulations, which would’ve diverted necessary resources away from the agency’s ongoing work on the pandemic.
“Based on a count cited in the SUNSET final rule, under the timeline and definitions provided in the final rule, over 7,000 sections of the Code of Federal Regulations promulgated by the Food and Drug Administration (FDA) are more than ten years old or would become more than ten years old during the first five years the rule would be in effect, representing over 95 percent of its current regulations,” HHS said in announcing the postponement.
HHS also said in its Federal Register notice that if the sunset final rule became effective as scheduled on March 22, then to avoid automatic expiration of these regulations, FDA and HHS “would need to immediately divert resources toward assessment and review during the ongoing COVID-19 public health emergency. In that event, FDA’s reviews of medical product applications, fulfillment of user fee commitments, and 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 would be significantly impacted.
“This concentration of resources in conducting regulatory review pursuant to the SUNSET rule could prevent FDA from modernizing its regulatory oversight more efficiently and addressing new regulatory needs,” HHS added, noting that it’ll delay the effective date of the rule by a year.
The department also said that it thinks a recent lawsuit from the Center for Science in the Public Interest and other groups to overturn the rule has some merits, and that this extension will allow the suit to proceed.
“Based on HHS’s initial review of the Complaint, HHS believes that the Court could find merit in some of Plaintiffs’ claims,” HHS said. “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.”
If the suit does not halt the rule, the Biden administration could just withdraw it, experts previously told Endpoints News, although HHS would still need to go through a notice-and-comment procedure to do so.