FDA Regains Rulemaking Authority in Reversal of Trump-Era Move (1)

The Food and Drug Administration once again has the authority to issue its own regulations under a notice issued Wednesday that reverses a Trump-era change.

Former Health and Human Services Secretary Alex Azar issued a memo in September 2020, requiring that all rules coming out of the department’s agencies and offices would need to be signed by the secretary.

The new notice, signed by HHS Secretary Xavier Becerra, “revokes the September 15 Memorandum as it applies to FDA and reinstates any delegations to FDA rescinded by the September 15 Memorandum.”

The move comes as the Biden administration is making a key part of its Covid-19 messaging around putting trust in the science and in the decisions of federal health officials.

The goal of the 2020 move was to minimize “litigation risk for the department’s public health actions” and prevent potential abuse of authority, the HHS said in a statement at the time. Some HHS rules have been challenged in court based on the argument that officials who signed the rules didn’t have the proper rulemaking power.

Rules have to go through a formal clearance process before they can be published. That process includes review by the agency writing the rule, the HHS, press staff, the Office of the General Counsel, and the Office of Management and Budget. Other departments and offices can be involved in the rule if they are relevant to the subject matter.

The process also typically included the signatures of the HHS secretary and the head of the relevant agency, although sometimes other agency officials would sign it, the department said in 2020.

Former FDA Commissioner Scott Gottlieb at the time called the move a “major distraction” that creates “an implication, or at least a specter” that the FDA’s independence is being “eroded or influenced.”

Gottlieb applauded the move Wednesday. “This decision by current HHS will restore an essential element of FDA’s independent judgment and allow the agency to act faster,” he said in a tweet.

Jeff Allen, president and CEO of Friends of Cancer Research, in a statement called the decision “a welcome modification” and said that it “restores FDA’s autonomy as it should be and will help the agency to act in a timely fashion as needed.”

—With assistance from Jeannie Baumann