OPINION:
Dr. Jayanta Bhattacharya, President-elect Donald Trump’s designee to head the National Institutes of Health, has urged reform in how the NIH awards more than $33 billion annually in biomedical research grants. His published studies show that the NIH’s funding criteria favor older researchers pursuing old, less risky ideas at the expense of young researchers pursuing new ideas.
A sound financial portfolio is usually well diversified. A research portfolio should be no different. The NIH should fund some risky research, some incremental research and some research in between.
The process by which the NIH awards research grants is dictated by legislation enacted in 1944, and a director’s ability to reform unilaterally may appear limited at first blush. But this 80-year-old statute, as amended, should not impede reform: It is unconstitutional on its face.
Under the current legislation, neither the NIH director nor the secretary of health and human services is permitted to award a research grant unless the application has been recommended for funding by two advisory committees.
One is a technical and scientific committee focusing on the type of research or ailment at issue. The other is a general advisory committee to the institute within the NIH that would be funding the research, e.g., National Cancer Institute, National Heart, Lung and Blood Institute, National Eye Institute.
These institute-specific advisory committees are called councils. Council members, in theory, are appointed by the secretary while the members of the technical and scientific committees are appointed by the NIH.
Requiring two sets of outside advisory committees to approve an application as a necessary precondition of funding by the secretary or director runs afoul of the Constitution’s appointments clause (art. II, § 2, cl. 2) and the structure of each department as mandated by the Constitution. The appointments clause recognizes “Officers of the United States,” “a class of government officials distinct from mere employees,” according to the Supreme Court in Lucia v. Securities and Exchange Commission.
Those appointed by the president with the advice and consent of the Senate are “Officers,” often called “principal officers.” Those appointed by the president without Senate confirmation, by the courts or by the heads of the departments are “inferior officers.” Everyone else in the executive branch is an ordinary employee.
An ordinary employee cannot limit what an officer may or may not do, and an “inferior officer” cannot limit what a “principal officer” can do.
The members of the hundreds of technical and scientific advisory committees are part-time, ordinary employees culled largely from academia. As employees, they have no ability to bind or veto an officer’s decision. Yet under the NIH’s organic legislation, these advisory committees can preclude the HHS secretary and the NIH director, both principal “officers,” and the institute directors from funding a research project they deem appropriate.
The council members associated with each institute are part-time “inferior officers,” and as such, their decisions cannot override the decisions of a principal officer, such as the HHS secretary or the NIH director. Indeed, to the extent that these part-time employees and part-time inferior officers could preclude a principal officer from awarding funds, they are discharging the authority of principal officers without having been appointed by the president or confirmed by the Senate.
Even if Congress were to denote them as principal officers and each were appointed by the president with advice and consent of the Senate (a practical impossibility given their vast numbers), they could still not override a decision of a department head, such as the secretary. Therefore, the NIH’s organic legislation is unconstitutional.
Does that mean that the NIH is precluded from funding biomedical research? Not necessarily. Rather, the director and secretary, having taken oaths to uphold the Constitution, can and should remedy the appointments clause infirmity by severing the unconstitutional authority of the advisory committees, thereby unshackling the director to fund research that he or she believes is in the best interest of the United States.
In comparable situations, courts have severed unconstitutional provisions. For example, after the Supreme Court found that the structure of an administrative tribunal within the Patent and Trademark Office violated the appointments clause because its decisions were effectively not reviewable by a principal officer, the court permitted the process to continue as long as the principal officer reviewed the tribunal’s decisions.
While the NIH statute violates the appointments clause, it appears likely that severing the unconstitutional restriction, namely the unilateral authority of an advisory committee or council to block the NIH director from funding a grant, would be permissible and should be the first step on the way to significant reform at the NIH.
• Robert P. Charrow served as general counsel at the Department of Health and Human Services from 2018 to 2021 and is the author of “Law in the Laboratory.”
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