How the new health secretary, Robert F. Kennedy Jr., is dismantling the agency.
Excerpt – More and more, people seemed to clamor for things that were unproven, to question things that were and to express not only mistrust but outright hostility toward the doctors, scientists and civil servants trying to separate one from the other. That hostility was being nourished by exactly the kind of mis- and disinformation Kennedy was espousing. It was easy to paint the F.D.A. as a supervillain (an aggressive suppressor of sunlight, vitamins and exercise, to borrow Kennedy’s language), in part because the truth was so much more complex.
Americans have always been ambivalent about public health in general and the American regulatory project in particular. We want protection from bad food and bad medicine and other unsafe products, but we also want to draw the line between safe and unsafe for ourselves and to redraw it whenever we see fit. The F.D.A. has always reflected this tension. On the one hand, the agency’s regulators have a truly enormous remit: Which drugs, medical devices, food, pet food, dietary supplements, tobacco products and cosmetics we can buy — one in every five dollars we spend, by official estimates — comes down to the decisions they make. On the other hand, the agency itself is profoundly under-resourced. [..]
Regulators had been working for years to get companies to reduce the salt content of their products and to add more and better “front of package” health warnings. Critics seemed to relish pointing out that other countries managed to implement both policies to great effect and with ease. But the United States was not like other countries. In the United States, corporations had the same rights as individuals and were likely to advance legal challenges against just about any rule with which they were confronted. To prevail in court, the F.D.A. would need its own research, which it did not have the money to conduct, or industry data, which it did not have the authority to demand.
To mount a broader attack on ultraprocessed food, which [Former FDA commissioner Robert] Califf agreed was designed explicitly to addict young children, the agency would have to contend with how those products were being promoted. Manufacturers used carefully tailored ads that appealed to consumers on an emotional level; the agency was restricted, by law, to plain facts. Like almost all its biggest challenges, the trouble boiled down to two things: The F.D.A. needed more money, and the F.D.A. needed more authority. Both were on Congress to provide, but lawmakers had a habit of heaping mandates on the agency without addressing either issue — and then heaping blame on regulators for every failure that resulted.
[..] it was not just the agency that had been captured by industry. Congress, doctors, patient-advocacy groups and a regulation-wary public had all played a role in weakening the F.D.A. For another, those who had served on both sides of the watchdog-regulator divide knew firsthand how mission-driven most of the agency’s rank and file were and how irrelevant political considerations were to their actual work. [..]
The F.D.A.’s real problem [..] was not so much industry capture as a fundamental weakness at the heart of the agency. In theory, its authority was ironclad. In practice, the agency’s position was like that of a federal judge who rules against a sitting president and is immediately confronted with a constitutional crisis. In the F.D.A.’s case, every interest group — from lawmakers to drug makers to doctors and patients — was president, and every judgment was a potential tipping point. This precariousness made agency officials deeply reluctant to admit mistakes or even to communicate openly. But that reluctance had costs of its own.
Multiple exposés of the F.D.A.’s role in the opioid crisis made the agency’s own silence on it deafening. In the thick of the pandemic, when clinical trials testing Covid-19 vaccines in children faced repeated delays, the agency’s failure to communicate left parents in a vacuum far more detrimental to public trust than any honest dialogue would have been. “They should have been briefing parents every week,” Joshua M. Sharfstein, a professor at the Johns Hopkins Bloomberg School of Public Health, told me. “A golden rule of public health is that if you don’t explain what you’re doing and why, someone else will explain it for you.”
[..] What good were transparency initiatives, they [people who spent their careers fighting with and for the agency] asked themselves, for people who trusted dietary supplements but not vaccines? Or who glorified public figures like Kennedy, who made millions spreading dangerous falsehoods, but viewed an entire class of underpaid civil servants as inherently corrupt? Reasonable people could certainly disagree about where to draw the line between access to new medical treatments and protection from harmful ones. But to be reasonable people in the first place, they needed accurate information — and a shared set of facts.
“There are certain norms that are understood, that shape policy discussions,” Sharfstein told me. “If someone decides those norms aren’t applicable anymore, it becomes very difficult to do the work of the agency.”
[..] The F.D.A. was deeply imperfect. It was lumbering and often opaque, and it had gotten many things wrong in its long history. But the agency had also been built around a set of principles — scientific inquiry, impartial judgment, collective responsibility — that represented the best of what a functioning government could do for its people. Now it was being deliberately dismantled, and a generation’s worth of experience and expertise was being thrown away.
As if that weren’t enough, the stewards of that legacy — the people who had worked long hours for low pay and faced constant criticism, all so that they might do what Frances Kelsey once did when she kept thalidomide off the market — were being treated like criminals. In Califf’s opinion, there was no good reason for any of it. “History will see this as a huge mistake,” he mused. “The F.D.A. as we’ve known it is finished.”
Full article, J Interlandi, The New York Times Magazine, 2025.7.8