HHS Delays Review of FDA Regulations to Focus on COVID-19 Relief

HHS is postponing implementation of a final rule issued late in the Trump administration that would have required the FDA to review practically every regulation it has and redirect resources away from pandemic relief efforts.

The SUNSET final rule was slated to take effect on March 22, but HHS has delayed the rule’s implementation by one year.

To meet its obligations under the rule, HHS would have needed to “immediately divert resources toward assessment and review during the ongoing COVID-19 public health emergency” or face an automatic expiration of regulations, the department said in a notice announcing the delay, scheduled for publication in the March 23 Federal Register.

More than 7,000 sections of FDA federal regulations code 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 more than 95 percent of its current regulations,” HHS said, adding that, without an exemption, the regulations would have had to be evaluated within five years and, “if applicable, reviewed or be subject to expiration.”

HHS warned that if the rule had gone into effect as planned, the 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.”

Going forward, such a regulatory review could prevent FDA from modernizing its regulatory oversight and addressing new regulatory needs, HHS said.

Several advocacy groups, including the Center for Science in the Public Interest and the Natural Resources Defense Council, are seeking to overturn the rule on the grounds that it is in violation of notice and comment rulemaking requirements. They filed a lawsuit against HHS on March 9 in the U.S. District Court, Northern District of California, San Jose Division.

Read the HHSnotice here: www.fdanews.com/03-19-21-Notice.pdf.

Read the complaint here: www.fdanews.com/03-19-21-Complaint.pdf. ― Jason Scott