September 20, 2020
HHS Statement on Regulatory Process
On September 15, the Department of Health and Human Services issued a memo on agency procedures, clarifying that all departmental rules, which are all issued by the Secretary, must now be signed by the Secretary.
The department released the following statement on this action:
“Before and after this action, no regulation issues from any part of HHS without the approval of the Secretary and the White House. The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him. Any speculation about this memo being motivated by policy considerations is utterly misinformed. This good-government action is only prospective in effect and minimizes litigation risk for the department’s public health actions, prevents potential future abuse of authority, and is consistent with congressional intent. The memo should have no effect on operational work and does not pertain in any way to guidances or any vaccine or drug approval or authorization. This action will not slow any HHS agencies’ work. It is simply the ministerial, administrative act of attaching a signature to a document.”
Further background on this action is included below.
Why send this memo?
Upon taking office, Secretary Azar began a process of reviewing the department’s processes for rulemaking. This work has proceeded in parallel with work by the White House Office of Management and Budget to reform rulemaking in a way that follows congressional intent and increases public confidence and accountability for rulemaking. It is common, in government and the private sector, to review delegations of power on a regular basis.
Part of that process included a review to determine which officials had been delegated power to sign rules, in order to ensure that these delegations were proper. Agencies, including HHS, have had rules challenged in court on the grounds that they were signed by officials to whom rulemaking power was improperly delegated. HHS disagrees with these allegations.
The department’s Executive Secretariat and Office of the General Counsel determined that there was no central accounting of these delegations. Therefore, the memo establishes a clean slate: All agency rulemaking must be signed by the Secretary.
This action has no effect on the procedures used for agency rules. Under the department’s current procedures, all rulemaking goes through a departmental clearance process, which includes approval by the Secretary.
Why send this memo now?
The memo was the product of an extensive review process, still ongoing, of how to ensure that HHS’s rulemaking procedures are consistent with congressional intent, minimize litigation risk, and provide public accountability.
How were rules issued before the memo and how will they be issued after the memo?
Before the memo, the process required that all rules issued by the department go through departmental and White House clearance and receive approval by the Secretary. The rules were typically signed by the Secretary and by the head of the agency involved. In some cases, other officials to whom authority had been delegated signed the rules.
After the memo, all rules issued by the department will continue to go through departmental and White House clearance and will continue to be approved by the Secretary. All rules will now be signed by the Secretary and by the head of the agency involved.
Does this memo add any delays to agencies’ ability to take actions during COVID-19?
No. All actions affected by this memo already go through a clearance process with the entire department and the White House Office of Management and Budget, an in-depth process where the action is thoroughly vetted.
The Secretary’s signing of a rule does not add a further layer of policy review on top of the current review process, because the current process ensures that rulemakings reflect the policy of the department and the administration.
Does this memo apply to vaccine or drug approvals or emergency use authorizations?
No, the memo only applies to rules, which follow different procedures and legal requirements than product approvals and authorizations, which are adjudications.
Does this memo apply to guidance?
No, this memo affects only rules, not guidances. Guidances from HHS follow a separate set of procedures.
Is this an attempt to exert greater political power over HHS agencies’ decision making and procedures?
No, this action has no effect on HHS agencies’ decision making and procedures in any way, which will be overseen by the same department processes. The action aims to ensure that rulemaking by HHS and its divisions—which cover vital public health matters—is consistent with congressional intent, minimizes litigation risk, and ensures public accountability.
Former heads of agencies with delegated rulemaking authority, such as the Food and Drug Administration, have recognized that questions around delegations of rulemaking power can create litigation risk. For instance, in 2019, Commissioner Scott Gottlieb signed and retroactively ratified the 2016 deeming rule around tobacco products, which had originally been signed by a more junior official. In fact, the former Commissioner’s action in that instance further highlighted the need for this particular comprehensive review to ensure that there was no procedural infirmity in HHS agency rules.
Does this send the wrong message at a time when Americans should have confidence that decisions are being made based on science and evidence?
Since the action has no effect on the substantive rulemaking process, the only reason it would undermine public confidence in rulemaking is if commentators misrepresent it to the public, as some unfortunately have.
Americans, especially during a public health emergency, deserve to have confidence in the procedures used to make legally binding rules, including confidence that these rules follow proper procedures and minimize litigation risk. That is the goal of this action.
Was the memo targeted at the Food and Drug Administration or any particular divisions of HHS?
No, the memo covers all Operating and Staff Divisions of HHS. Large agencies that release a significant amount of rules, such as the Food and Drug Administration, already have robust processes for sending any rules through departmental and White House clearance. Those processes will remain unchanged, except that they will now conclude with the Secretary’s signing the rule in all cases.
Does this have any impact on actions taken under previous delegations?
No, this memo has no impact on actions taken under previous delegations. It is prospective in effect.