HHS Secretary to Sign All Rules in Bid to Stem Litigation

The secretary of health and human services will now sign all rules coming out of the department and its agencies, according to a Sept. 15 memo made public Sunday.

The move requiring the secretary’s signature—in addition to that of the relevant agency head—"minimizes litigation risk for the department’s public health actions, prevents potential future abuse of authority, and is consistent with congressional intent,” the HHS said in a statement Sunday. 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, so this was intended to stop those issues.

The memo affects all rules coming from all agencies and offices of the HHS, the department said, including the Food and Drug Administration, Centers for Medicare & Medicaid Services, and Office for Civil Rights. But it doesn’t apply to guidance documents, emergency use authorizations, or vaccine or drug approvals.

The memo provides the department’s justification for the change, as critics charged that the move could affect public trust in the Covid-19 drug and vaccine approval process, especially with additional attention on concerns about possible political interference by Trump administration officials.

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 staffs, 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.

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

“The timing of this is really poor right now because it’s going to distract the agency and frankly creates headlines that could leave the perception that the agency is being bullied,” Gottlieb said Sunday on CBS.

The HHS rebutted Gottlieb’s comments, saying the action has “no effect on HHS agencies’ decision making and procedures.”

The HHS also pointed to Gottlieb signing a 2016 rule around tobacco products, which had been signed by an agency official who wasn’t the commissioner, prior to his departure from the agency.

The HHS also said this this would only “undermine public confidence in rulemaking is if commentators misrepresent it to the public, as some unfortunately have.”