Published on:

HHS Restores Rulemaking Authority to FDA

The Department of Health and Human Services (HHS) recently issued a notice restoring the rulemaking authority of the Food and Drug Administration (FDA). Under the Trump Administration, HHS had issued a memorandum, in September 2020, which required that all rules promulgated from the department’s agencies and offices would need to be signed by the secretary. The new notice specifically “revoked the September 15 Memorandum as it applied to FDA and reinstates any delegations to FDA rescinded by the September 15 Memorandum.” HHS’s recent notice delegating rulemaking authority to the FDA includes the authority to issue regulations pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), applicable portions of the Public Health Service Act (PHS Act), and other authorities governing functions of the FDA.

According to an HHS press release at the time, the goal of the September 2020 memorandum was to minimize “litigation risk for the department’s public health actions” and prevent potential abuse of authority. Some HHS rules have been challenged in court under claims that officials who signed the rules did not have the proper rulemaking authority. Rules must undergo a formal clearance process prior to being published. That process includes review by the agency writing the rule, HHS, press staff, the Office of the General Counsel (OGC), and the Office of Management and Budget. Other offices and departments may be involved in the rulemaking process if they are relevant to the subject matter of the proposed rule.

While some applauded the September 2020 memorandum for reigning in the FDA’s authority during the COVID-19 pandemic, when the agency’s burdensome regulations prevented much-needed products, especially COVID-19 testing devices, from reaching patients, others expressed concern over its possible negative effects. Former FDA Commissioner Scott Gottlieb at the time described the move as a “major distraction” that creates “an implication, or at least a specter” that the FDA’s independence is being “eroded or influenced.” After the new notice was issued, Gottlieb applauded the move in a tweet, saying that the “decision by current HHS will restore an essential element of FDA’s independent judgment and allow the agency to act faster.”

For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or


Contact Information