More than 15 years after the National Academy of Medicine summoned a blue-ribbon panel to “reimagine” the Department of Health and Human Services for the 21st century, the cabinet-level operation has yet to make good on the experts’ overarching directive:
Refocus HHS on its reasons for existence—its vision, mission and goals—so as to, for starters, define the full American population’s most pressing health challenges.
Meanwhile the FDA, one of HHS’s mission-critical operating divisions, is “struggling to perform basic functions, from inspection logistics to product review.”
The observations of HHS’s present predicaments are from separate commentaries offered by former federal health officials. Both pieces are running in JAMA Health Forum.
Sharfstein’s speculations
In “Making HHS Great to Advance Health in the US,” Joshua Sharfstein, MD, erstwhile principal deputy commissioner of the FDA, walks the reader through a chronological summary of fits, starts and fumbles over the years since NAM convened its expert committee in 2009. (At the time it was called the Institute of Medicine.)
When he comes to President Donald Trump’s appointment of Robert F. Kennedy Jr. as HHS secretary in early 2025, Sharfstein notes Kennedy’s tenure has been marked by various controversies.
However, Sharfstein writes, Kennedy has “reenergized the role and, in doing so, has reopened the long-standing debate over the structure and function of national leadership on health.”
Sharfstein cites several of Kennedy’s contributions. These include spearheading the Make America Healthy Again movement, warning of an “epidemic of chronic illness” and proposing a reshuffle of HHS’s 12 subagencies to set up the “Administration for a Healthy America.”
Pros, cons and outcomes to be determined
As for Kennedy’s missteps, Sharfstein lists controversially reducing the use of acetaminophen during pregnancy, “arbitrarily and capriciously” changing vaccine recommendations and other instances.
Moreover, Sharfstein states, “rather than supporting HHS staff, Kennedy’s repeated criticism of the CDC and the FDA, along with his attacks on science at the NIH, have led to demoralization and the resignations of numerous scientists and other senior career officials.”
The next presidential administration, and Congress, “will have a chance to reset HHS for the future,” Sharfstein concludes. “The opportunity is to draw from old and new recommendations to empower the HHS to establish a set of meaningful goals for health—and then use the nation’s scientific expertise, billions in funding, and considerable legal authority to achieve them.”
Hear out Sharfstein in full here.
Gottlieb’s guesstimations
Drilling down into challenges and opportunities at the FDA is Scott Gottlieb, MD, who served as commissioner of that agency from May 2017 until April 2019.
In the short essay, somewhat cheekily titled “Making the FDA Great Again,” Gottlieb laments the shrinkage of the agency—by thousands of nudged resignations and outright terminations—to the point where “parts of the FDA have been set back almost two decades.”
On the bright side, Gottlieb suggests, is a possible change of course as after the March elevation of a “political unknown,” Chris Klomp, MBA, to HHS chief counselor.
The Washington Post suggests the move may signal an unofficial sidelining of Kennedy, whom White House advisors want “deployed to the campaign trail this year.”
In his JAMA Health Forum commentary, Gottlieb observes that the May departure of Marty Makary, MD, as FDA commissioner “creates an opening for HHS to reconsider how the FDA is governed, what kind of leadership it requires, and where the boundary lies between political power and scientific judgment.”
Hope for fair winds with so much up in the air
Gottlieb withholds speculation on how well FDA Acting Commissioner Kyle Diamantas may do, but he worries that “putting political appointees in charge of the medical product centers conflates two things that should not be confused.”
He seems to be talking about healthcare policymaking on the one hand and reviewing medical products on the other.
“When I led the FDA, we made a concerted effort to streamline review of complex generic drugs, and crafted new policies related to opioid drugs to ensure they were thoroughly evaluated for their potential to be diverted and used illicitly,” Gottlieb writes. “Both efforts lined up squarely with the first Trump administration’s policy goals of lowering drug costs through generic competition and confronting the opioid epidemic.”
These policies, he maintains, were “implemented in the way the FDA was built to get things done.”
A lot has changed since then, he suggests, and observers are not wrong to be concerned.
“Trying to seize control of the medical review centers does not expand the power of political leaders,” Gottlieb writes. “Rather, it collapses the structure that allows the FDA to achieve reforms that political leaders most want to see.”
