By Gina Shaw

The Senate’s Health, Education, Labor and Pensions (HELP) Committee will vote Thursday, March 13, 2025, on the nominations of Stanford health economist Jayanta Bhattacharya, MD, as director of the National Institutes of Health (NIH), and Johns Hopkins surgeon Martin Makary, MD, as commissioner of the FDA, after hearings on the nominations held March 5 and 6.

In his opening statement to the committee, Dr. Bhattacharya said he would have five priorities if confirmed: focusing NIH research on chronic diseases; ensuring science is “replicable, reproducible and generalizable”; fostering a culture of free speech in science; prioritizing NIH funding for innovative, cutting-edge biomedical research; and limit what he called “risky” research.

Given his stated support of NIH research, the HELP Committee asked Dr. Bhattacharya about his views on the Trump administration’s effort to cap indirect cost rates for NIH grants. Such cuts are part of the Department of Health and Human Services’ efforts “to support the President’s broader efforts to restructure and streamline the federal government,” an HHS spokesperson noted in a statement emailed to the media. “This is to ensure that HHS better serves the American people at the highest and most efficient standard.” 

Dr. Bhattacharya replied that he would “follow the law” regarding the NIH cuts, adding that while he acknowledged the importance of indirect costs, “there’s a lot of distrust” about that spending and raised the potential of audits for NIH-funded research. 

He also stressed that he would “absolutely” restart NIH study section meetings that have been put on hold. “My job would be to ensure that those fundamental scientific meetings and other activities happen,” Dr. Bhattacharya said.

Georges Benjamin, MD, the executive director of the American Public Health Association, said the stakes could not be higher for Dr. Bhattacharya if he passes the confirmation process and heads up the NIH. “U.S. biomedical research has come to a screeching halt, and his first task is going to have to be to restart the engines and get research back on track,” Dr. Benjamin said. “He’ll have to take a stand. If he’s going to be in charge, be in charge and move the agency forward.”

COVID-19 Controversy

Dr. Bhattacharya’s support of a controversial position related to COVID-19 also came up during the hearings. In October 2020, he was a signer of the “Great Barrington Declaration,” which called for an end to COVID-19 pandemic lockdowns, mask mandates “and similar restrictive policies on the ground that they disproportionately harm the young and economically disadvantaged while conferring limited benefits,” as noted in a 2023 prepared statement he delivered to Congress. The declaration claimed the most effective way to combat the pandemic would be to speed herd immunity by allowing “low-risk” populations to become infected. 

The proposal was condemned by many leading scientists, including former NIH director Francis Collins, MD, who called it “a fringe component of epidemiology” in an interview with the Washington Post. “This is not mainstream science. It’s dangerous. It fits into the political views of certain parts of our confused political establishment.” (Dr. Collins retired from the NIH on Feb. 28.)

The Infectious Diseases Society of America shared those concerns, calling the herd immunity concept framed in the Great Barrington Debate as “inappropriate, irresponsible and ill-informed” in an October 2020 statement. 

During the hearing, Dr. Bhattarchaya criticized such responses to the declaration. In the case of the NIH, he noted, “top officials oversaw a culture of cover-up, obfuscation and a lack of tolerance for ideas that differed from theirs. Dissent is the very essence of science.”

Dr. Benjamin disagreed. “On COVID, he was wrong. The Great Barrington Declaration was a nonscientific, political document released into a charged environment where there was a lot of misinformation circulating. I hope he will learn from that and engage the scientific community in productive ways as he goes forward.”

He predicted that Dr. Bhattacharya will ultimately be confirmed by the full Senate. “I have disagreed with him on things like his response to COVID, but I think he most likely will get the job, and we are going to have to find ways to help him be successful.”

Dr. Makary Navigates Hot Topics

In his hearing for the top spot at the FDA, Dr. Makary, the chief of Islet Transplant Surgery at Johns Hopkins Medicine, in Baltimore, avoided making commitments on several hot topics, including maintaining access to the abortion medication mifepristone.

“I have no preconceived plans on mifepristone policy except to take a solid, hard look at the data and to meet with the professional career scientists who have reviewed the data at the FDA, and to build an expert coalition to review the ongoing data, which is required to be collected as a part of the REMS [Risk Evaluation and Mitigation Strategy] program,” said Dr. Makary, who has attacked researchers and health officials in TV appearances and books like “Blind Spots: When Medicine Gets It Wrong, and What It Means for Our Health. It’s possible, he noted, “that there could be a drug–drug interaction that we could identify.” 

Medication abortion was first approved in the United States more than 20 years ago, and a substantial body of evidence indicates that it is both safe and effective (JAMA Intern Med 2022;182[5]:482-491; BJOG 2021;128[9]:1464-1474).

“There is no question about [Dr. Makary’s] intellectual skills, and everyone I know who knows him thinks that he is a very good clinician,” Dr. Benjamin said. However, “in the hearing, he was very skilled at not making any commitments but agreeing, ‘I’ll look at anything.’”

Dr. Makary insisted that he had not been involved in the abruptly canceled the March 13 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) that was intended to discuss updated strain recommendations for flu vaccines. In response to a question from Sen. Susan Collins (R-Maine), he said “the VRBPAC committee will be meeting” but would not specifically commit to a date for that rescheduling. Dr. Makary said the committee has previously “rubber-stamped” international consensus on the most dominant flu strains.

Sens. Angela Alsobrooks (D-Md.), Tammy Baldwin (D-Wis.) and Patty Murray (D-Wash.), all members of the HELP Committee, sent Dr. Makary a letter on Feb. 28 about the cancellation, telling him that they intended to use the hearing to “understand whether you support this ill-informed measure to slow critical public health decision making.”

“The cancellation of next week’s VRBPAC meeting is unprecedented. This Committee has met every year for the past 30 years to discuss the influenza virus vaccines for the upcoming flu season and make recommendations to the FDA. It is essential for this meeting to occur, and its expert recommendations to be issued, in a timely, routine manner,” they wrote. “Any delay in the Committee meeting and issuing recommendations may impact flu vaccine availability and effectiveness, if manufacturers do not have sufficient time to prepare the correct vaccines.”

Vaccine-Preventable Deaths ‘a Tragedy’

Dr. Makary declared support for vaccines during the hearing: “Vaccines save lives, and I do believe that any child who dies of a vaccine-preventable illness is a tragedy.”

Dr. Makary also said he "respects" the staff at the FDA, "which I am glad to hear, because he has said some very negative things about them,” Dr. Benjamin said. “Being an armchair critic of an organization is very different than when you have the job. I’ve had to make that transition from outside to inside. He is going to have to win people over.”