The U.S. Senate has confirmed surgeon Marty Makary as the commissioner of the FDA in a March 25 vote of 56-44, installing the oncological surgeon as the agency’s 27th commissioner. The Senate also voted March 25 to confirm Jayanta (Jay) Bhattacharya as the director of the National Institutes of Health by a vote of 53-47, bringing the Department of Health and Human Services two steps closer to a complete roster of agency leaders.
Makary is a member of the faculty at Johns Hopkins Hospital, which lists him as a professor of surgery and the chief of islet transplant surgery.
In his stewardship of the FDA, Makary may focus to some extent on the cost of healthcare, which was the subject of a book he published in 2019. That book, titled, “The Price We Pay” made the New York Times Best Seller list. He authored another book that also made the NYT Best Seller list, titled, “Blind Spots: When Medicine Gets It Wrong, and What It Means for Our Health.”
In his March 6 testimony to the Senate Health, Education, Labor and Pensions (HELP) Committee, Makary said transparency in healthcare could help reduce costs, and raised questions about the increasing prevalence of cancers of the liver. He stated that childhood obesity “is not a willpower problem,” adding that his time at the FDA would be focused in part on “radical transparency” in healthcare. Makary takes over at the FDA at a time when the agency has lost a significant number of staff members and faces litigation over the agency’s rulemaking for regulation of lab-developed tests.
The Advanced Medical Technology Association (AdvaMed; Washington) applauded the Senate confirmation of Makary in a March 26 statement describing him as a renowned surgeon and health policy expert. Scott Whitaker, President and CEO of AdvaMed, said Makary understands the importance of “improving patient access to transformative medtech.”
Whitaker stated further that AdvaMed looks forward to working with Makary “on two mutually shared goals. First, to advance the administration’s ‘Make America Healthy Again’ agenda, which is at the heart of what our companies do day in, day out.” The second shared goal, Whitaker said, is “to ensure FDA remains the global gold standard for its rigorous medical device safety and efficacy standards,” adding, “an efficient, transparent FDA is key to both goals”.
Bhattacharya has served as a professor of medicine, economics and health policy at Stanford University, where he has conducted research into the economics of health and aging. He takes the directorship of an agency with a budget of nearly $48 billion and a controversy over the percentage of NIH grants that are applied to indirect costs.
In his testimony to the Senate HELP Committee, Bhattacharya indicated he would redirect NIH assets on chronic diseases, stating that life expectancy in the U.S. was essentially flat between 2012 and 2019. Expectancy fell further during the pandemic, he stated, adding that there is no apparent reversal of that trend.
Bhattacharya said the data behind a significant percentage of NIH-funded research fail the tests for reproducibility and reliability, citing the instance in which basic research into Alzheimer’s was eventually discovered to have been fabricated. He stated that NIH has suffered from a lack of respect for dissent, adding that he will foster an atmosphere in which all NIH scientists, including early-career researchers, are able to express their views without fear of reprisals.
Another point of focus at NIH will be on grants awarded for cutting-edge research as opposed to research that would only incrementally improve patient outcomes. He said also that the agency should tightly scrutinize risky research that could lead to a pandemic. Bhattacharya will serve as the 18th director of the NIH.