October 24, 2020

Volume X, Number 298

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A New Policy by HHS Secretary Alex Azar Will Prevent FDA and Other Health Agencies From Signing Final Rules

The Food and Drug Administration (FDA) is one of 27 agencies and offices within the U.S. Department of Health and Humans Services (HHS).  FDA’s final rules have typically been signed by the FDA Commissioner, or more often a lower appointed officer within the agency.  FDA’s rules have not usually been signed by the HHS Secretary, who is a Cabinet member with the primary role of advising the President on public health-related matters.  The authority of an appointed officer to sign a final rule has been challenged recently in the context of FDA’s “Deeming Rule,” which extended the Agency’s tobacco authority to e-cigarettes.  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.

In a September 15, 2020 memorandum reported on last week, the current HHS Secretary, Alex Azar, barred the FDA and other health agencies from signing any new rules regarding the nation’s food, medicine, and other products under the HHS umbrella.  The Secretary’s office characterized the new policy as an overdue “housekeeping” matter unrelated to any particular agency or current issue.  Others, however, questioned the impact of this new policy on public trust in the standard scientific and regulatory processes at health agencies, noting the timing of the Secretary’s memorandum close on the heels of controversial COVID-19 guidelines posted over the objection of its own scientist by the Centers for Disease Control and Prevention (CDC), which reversed course this weekend after charges of political interference, and questions about when a new corona virus vaccine will be approved.

Regardless of any other impact, such as possibly creating a new avenue of attack on FDA’s deeming rule, the new requirement that rules be signed by the HHS Secretary certainly presents a new layer of red-tape that could substantially delay the rulemaking process for all FDA regulations.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 265
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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