Recent shifts in policy and practice by the Department of Health and Human Services (HHS) have come under scrutiny for potentially reneging on the pledge of openness laid out by Secretary Robert F. Kennedy Jr. He assured during his confirmation hearings, as well during a press briefing at the White House, that his hallmark management style as HHS Secretary would be one of ‘radical transparency’. However, some of Kennedy Jr’s ensuing decisions, albeit within the legal framework, seem contradictory to that initial promise.
A case in point was the scheduled two-day assembly of the Advisory Committee on Immunization Practices on February 26, 2025. The committee plays a vital role in recommending vaccination schedules for children and adults, endorsement of vaccines, and monitoring vaccine safety. One of the key deliverables of this meeting was voting on the recommendation of some newly approved vaccines.
Surprisingly, the meeting was deferred five days before its due date. The official reason cited for this delay was to ‘accommodate public comment ahead of the meeting.’ The Centers for Disease Control (CDC) bears the responsibility for scheduling the commenting period and as of this moment, none has been slated. Instead, a new meeting date was set for April 15 and 16 with no additional details provided regarding the reason for the change or potential further adjustments.
In a similar vein, a meeting of the Vaccines and Related Biological Products Advisory Committee, overseen by the Food and Drug Administration (FDA), was canceled less than a week later. Both the scheduled meetings were seen as public opportunities to discuss and understand policy around vaccines implemented by the CDC and FDA. Unfortunately, the cancellation of these meetings is viewed as a step back in terms of transparency.
Following this, on March 3, 2025, the 1971 Policy on Public Participation in Rule Making, also known as the Richardson Waiver, was revoked by HHS. The Administrative Procedure Act (APA) exempts its notice-and-comment mandates and several other requirements related to ‘any matters touching on agency management or personnel or to public property, loans, benefits, grants, or contracts.’
However, the HHS posited that the policy that waives the statutory exemption for regulations relating to public property, loans, contracts, grants, benefits contradicts the explicit wording of the APA. It argued that the waiver places unnecessary obligation on the department beyond the uppermost procedural requirements elucidated in the APA.
The APA itself acknowledges that it’s both necessary and fitting to issue directives related to agency management, public property, loans, benefits, grants, contracts, or personnel without the necessity of notice and comment procedures. Consequently, the department decided to rescind the Richardson Waiver instantaneously, and it is no longer the department’s policy.
The important concern raised is that the removal of this policy may potentially hamper public involvement and breed less transparency in the process of rulemaking. The department is no longer obligated to issue a notice prior to acting or provide an opportunity for public commentary. The outcome is a decreased pre-emptive warning, lesser opportunities for public involvement, and a real possibility that the public and stakeholders will only be made aware of policies post-implementation.
With a budgetary allocation of $2.40 trillion, which represents 20.6% of the total U.S. federal budget in 2025, the HHS oversees an immense wealth of resources. The organization distributes grants that support extensive immunization programs across all states, territories, and several major cities in the U.S, although this procedure has increasingly become complicated in recent years.
Furthermore, funds from HHS significantly contribute to various groups providing crucial health services. However, the ability to revise the rules and policies guiding the disbursement of funds, executed without prior transparency or chances for public input, could potentially destabilize immunization programs.
The new policy is predicted to impact most regulatory areas within the stewardship of HHS, which includes not just FDA but also Medicare/Medicaid. Yet, the specific effects of this policy change on these areas remain uncertain.
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