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New HHS Policy Will Prevent FDA and Other Health Agencies from Signing Final Rules

Stacks of binders of regulations

In a September 15, 2020 memorandum, the U.S. Department of Health and Humans Services (HHS) Secretary, Alex Azar, barred the Food and Drug Administration (FDA) and other health agencies from signing any new rules regarding the nation’s food, medicine, and other products under the HHS umbrella. Final rules from FDA—one of 27 agencies and offices within HHS—have typically been signed by the FDA Commissioner or, more often, by a lower appointed officer within the Agency. The authority of an appointed officer to sign a final rule was challenged recently when, in 2019, vaping industry plaintiffs unsuccessfully attempted to invalidate the rule by questioning the authority of the FDA official (the Associate Commissioner for Policy) who signed the rule.

The Secretary’s office characterized the new policy as a “ministerial, administrative act of attaching a signature to a document” in a press release about the memorandum. Others, however, questioned the impact of this new policy on public trust in the standard scientific and regulatory processes at health agencies. A September 19, 2020 New York Times article notes that Dr. Peter Lurie, former FDA Associate Commissioner and President of the Center for Science in the Public Interest, called the new policy “a power grab.”