The reckoning that Robert Califf spent years warning about began, as so many things seem to these days, on social media. It was October 2024. His tenure as commissioner of the Food and Drug Administration was winding down, and he was starting to imagine a happy retirement surrounded by grandchildren when he noticed Robert F. Kennedy Jr. taking aim at his agency, and the 19,000 or so people who worked there, on X.
“FDA’s war on public health is about to end,” Kennedy wrote. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma. If you work for the FDA and are part of this corrupt system, I have two messages for you. 1. Preserve your records, and 2. Pack your bags.”
It was a confused, almost comically pompous declaration, Califf recalls thinking, and it ought to have been the least of his concerns. Kennedy had not yet been tapped to serve as anything, let alone the highest health official in the land. Still, it struck a nerve. 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.
The F.D.A. receives less money from Congress than any of its sibling institutions, including the Centers for Disease Control and Prevention and the National Institutes of Health. In fact, its federal budget is roughly the size of the budget of the local school district in Montgomery County, Md., where it is based. Its infrastructure is wildly inadequate: fax machines, clunky computer systems, warehouses full of paper records that should long since have been digitized. And its staff members are poorly paid and frequently outgunned by the companies they are charged with regulating.
One perfect example of this dynamic involved the food and beverage industry, which Kennedy was so fond of calling out. 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 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.
But it was not just stingy congresspeople and litigious corporations that frustrated and worried Califf. He and his colleagues had also been engaged in a decades-long debate with a sprawling community of watchdogs — mostly doctors, lawyers and scientists from outside the agency — who were often broadly supportive of the agency’s mission but who fought with officials like Califf, sometimes bitterly, over the specifics: How should the F.D.A. be financed? What kind of evidence should new drugs and medical devices require? How should regulators weigh the concerns of industry against the needs of doctors, patients and consumers?
In Califf’s opinion, the watchdogs tended to amplify every disagreement and misstep, without acknowledging the vast areas of consensus — or the fact that most of the time things went exactly as they were supposed to. That was not to say that the agency was infallible or that it should not be scrutinized. But the way he saw it, their critiques were undermining public trust and providing ammunition to those less interested in improving the agency than in dismantling it altogether. “I think often the people that are doing the critiquing assume that the agency is going to be there in the future,” he warned at a conference in 2023. Now it looked as if the crisis he had sensed coming for a long time was finally here.
When President-elect Trump tapped Kennedy to head the Department of Health and Human Services in mid-November, Califf reconsidered Kennedy’s post. If “preserve your records” was meant as a threat, Califf interpreted it differently. “He’s right,” he told his staff as his tenure wound down. “We need to save every last record we have. Because one day, somebody will have to figure out how to put this all back together again.”
In late January, the new cost-cutting initiative known as the Department of Government Efficiency (or DOGE) asked leaders across H.H.S. to verify lists of probationary staff (those hired or promoted within the past year). Jim Jones, a former administrator at the Environmental Protection Agency who took control of the F.D.A.’s food division in September 2023, was standing with his colleagues when the request came in. Their hearts seemed to sink in unison as they pored over the list together.
“We looked at each other and said, ‘They’re going to fire them all,’” he told me afterward. “That was quite a chilling moment.” Jones was initially optimistic about Kennedy’s appointment. The F.D.A.’s chronic disease and chemical-safety programs had long been among the agency’s most poorly funded, and Kennedy was the only prospective secretary he could think of who had mentioned either, let alone vowed to prioritize both. Jones’s team had just finished revamping the F.D.A.’s Human Foods Program, the largest reorganization in the agency’s long history. And the changes they had implemented, and the ones they were still working on, were all in line with Kennedy’s stated goals.
They had changed the food division’s leadership structure to clarify chains of command. They had bolstered the nutrition department and created a new office to review the safety of chemicals used in food. They had revoked the agency’s approval of Red Dye No. 3 and finalized a rule defining which foods can be labeled “healthy.” They had also announced the next phase of their sodium-reduction initiative and proposed another rule that would require companies to put nutrition labels on the front of food packages.
They still had work to do. The food-safety division was grossly understaffed, and while inspection schedules had improved (once a year instead of once every three years for infant formula, for example), they were still inadequate. According to an investigation by ProPublica, some infant-formula plants continued to be plagued by leaky pipes and other contamination issues, and the F.D.A. was not doing nearly enough to punish companies for violations. But they were making progress, and with a leader who seemed focused on their normally neglected division (the “F” in “F.D.A.,” as they liked to remind people), Jones was hopeful that they would stay the course even as the political winds shifted.
In mid-February, 89 people from his own team and several hundred more from across the agency were fired in a process that seemed to Jones needlessly cruel, astonishingly clumsy and potentially illegal. Managers had not been told who was going or staying, nor given a chance to weigh in about which cuts made the most sense. Most people found out via email that they had been terminated, but many did not know until they came to work and discovered that their badges had been deactivated.
In Jones’s department, the people fired were the ones most needed for the things the health secretary had said he hoped to focus on. “There is nothing strategic about it,” Jones told me at the time. Nobody seemed to have weighed DOGE’s reductions against Kennedy’s stated agenda. He hoped that Kennedy would push back against Musk’s team or that somebody up top would call attention to the discrepancy between rhetoric and action and then change course. But it soon became clear that no such cavalry was coming.
Jones resigned the following week, in protest and defeat. “The only thing I’d be doing would be trying to scramble to plug all the holes being created by decision makers outside of H.H.S.,” he told me at the time. “There would be very limited opportunity to work on the secretary’s agenda.”
In the weeks that followed, the chaos only deepened. The new administration seemed to rule by social media post alone and to relish the confusion those missives caused. Rumors that DOGE operatives were patrolling the corridors of F.D.A. and H.H.S. with lie detectors drove a protective wedge between those who had been terminated and those who remained: There was a gag order in place, which meant that discussing agency business with anyone outside the agency was grounds for termination. The fired staff members I spoke with were worried that just calling their former colleagues might cost them their jobs.
‘We looked at each other and said, “They’re going to fire them all.”’
New return-to-office policies, meanwhile, were forcing thousands of F.D.A. employees into a headquarters that was never meant to accommodate them all. Those who had been working remotely now faced hourslong drives followed by hourslong waits to access the main campus, and then not enough parking spaces, office spaces, maintenance staff or I.T. support once they got there. Worst of all, a Legionella outbreak that had plagued the water supply for several weeks was not entirely resolved, according to Jeremy Faust, a physician at Brigham and Women’s Hospital in Boston, who reports on the F.D.A. for his Substack, Inside Medicine.
Neither Jones nor any of his colleagues or former colleagues could discern the purpose of any of the new measures, least of all the staff cuts. “You have to have a deep cynicism about what these workers are doing to believe that fewer of them is better,” Peter Lurie, a doctor who was an associate commissioner during the Obama administration, told me, as more layoffs were announced one early spring afternoon. Most offices were understaffed, almost as a rule, he said. The ones that weren’t tended to be paid for by user fees (money that drug and device makers give the agency to cover the cost of reviewing their products). But neither DOGE members who counted those layoffs as a cost-cutting win nor the health secretary himself seemed aware of this fact.
The principles governing Kennedy’s Make America Healthy Again movement are simple: Conventional medicine has largely failed us, as rising rates of autism, obesity and chronic disease clearly demonstrate. And the profit-driven industries that hold such sway over our health cannot be trusted. Those who feel betrayed by our corporate health care system should be free to turn to the vast array of alternatives — adult stem-cell injections, dietary supplements, raw milk and testosterone therapy for men, to name a few — at their disposal. It’s true that many of these alternatives have not been tested or proved beneficial in the conventional, scientific way. But in a free society, personal choice should be paramount. “If you want to take an experimental drug — you can do that, you ought to be able to do that,” Kennedy said on one podcast. “And of course you’re going to get a lot of charlatans, and you’re going to get people who have bad results.” He went on, “Ultimately, you can’t prevent that either way.”
But that was exactly what the modern F.D.A. was created to do: prevent Americans from being swindled, or worse, by purveyors of ineffective medicine. In the early 1960s, when the agency was still restricted to vetting products for safety, Americans spent a billion dollars or so a year on a wide range of wholly untested elixirs, including pigskin extract, bottled seawater and shark oil. It was clear to health officials that many of these products did not work, and that the very ill were especially vulnerable to scammers.
Some lawmakers and consumer advocates wanted to establish standards for effectiveness. Ensuring that health products worked as advertised seemed like the least a government could do for its people, they argued. But Congress was sharply divided over whether to expand the F.D.A.’s authority. No other federal agency had that kind of power: to decide what counts as safe, what counts as effective, what counts as evidence and then to permit or prohibit sales based on those criteria. No other nation in the world had that kind of barrier around its pharmaceutical market. And as the historian and Harvard professor Daniel Carpenter notes in his epic 2010 history of the agency, “Reputation and Power,” the United States — home of big business, small government, free markets and free choice — was an odd place to set such a high bar.
It was in the shadows of this debate, in 1960, that an application for a new sedative called thalidomide landed on the desk of Frances Kelsey, a pediatrician and pharmacologist who had just joined the F.D.A.’s drug division. Thalidomide was Kelsey’s first assignment, and it was meant to be a softball (sedatives tended to be simple drugs, and this one was already on the market in Europe). But after noting several errors in the application, she asked the applicant for more data. The drug’s makers pressed Kelsey’s bosses to bypass her and approve their product quickly, but Kelsey’s bosses stood firm.
Eventually, it became clear that thalidomide caused serious birth defects, including missing and malformed limbs, when women took it during pregnancy. Thousands of babies around the world had already been affected. Thanks to Kelsey and her colleagues, most infants in the United States were spared. It was in the wake of those revelations that Congress finally granted the F.D.A. new authority to require that drugs be proved effective — with adequate, well-controlled clinical trials — before they could be sold to American consumers.
President John F. Kennedy signed those powers into law in 1962, with Kelsey standing behind him. The new statutes helped set a new global standard. They also touched off what experts now refer to as a golden age of clinical medicine, not only by clearing the market of junk medicine but also because consistency and rigor turned out to be great both for industry innovation and for consumer confidence.
Over the next three decades, the F.D.A.’s reputation soared. Even as mistrust in other federal institutions grew, Carpenter writes, a vast majority of Americans understood what the agency was doing — and approved. But that honeymoon came to an end in the late 1980s and early 1990s, when regulators faced an array of new challenges. Advances in technology were triggering an explosion in the number and types of drugs being developed. Highly vocal AIDS activists began demanding access to some of those new drugs as quickly as possible. And just as the F.D.A.’s workload was expanding, a rising anti-regulatory fervor shrank the agency’s budget and diminished its sway over lawmakers.
In 1992, the agency implemented two new policies to address these issues. It created an accelerated pathway for approving certain drugs (those designed to treat deadly diseases for which there was no current treatment) with less evidence. It also began charging drug makers (and eventually, medical-device makers) for product reviews, through new “user fee” laws.
For a while, the fixes worked as intended. A yawning gap in the F.D.A.’s budget was finally plugged. Product reviews became faster and more efficient, and more of those products made it to market. But before long, critics were arguing that the fees gave industry far too much influence and that, as a result, exceptions to the nation’s high drug-approval standards were becoming the rule. In the late 1990s, the agency began requiring fewer clinical trials for some drugs. In the 2000s, it modified the efficacy standards for others.
By then, a majority of new drugs were being routed through one expedited approval process or another. The United States had also become one of just two countries where drug makers could advertise their products directly to consumers. And the F.D.A. was being excoriated for its role in exactly the kind of deadly mishaps it was created to prevent. The heart medication Vioxx was linked to heart attacks and strokes; the antidepressant Paxil increased the risk of suicide in teenagers; prescription opioids like OxyContin helped seed an overdose crisis that would go on to claim 100,000 lives a year. In “Doctored,” a book about the quest to cure Alzheimer’s, published this year, Charles Piller details how the agency failed to properly police clinical trials for safety or fraud.
Gardiner Harris, a former Times reporter, unpacks what he sees as a grim roster of additional failures in “No More Tears,” his 2025 book about Johnson & Johnson: baby powder that contained asbestos, a cancer drug that increased tumor growth, medical devices that caused debilitating injuries. In case after case, Harris writes, the company knew its products were dangerous but withheld data from the F.D.A. Thousands of deaths and serious injuries may have resulted. Johnson & Johnson rarely received more than a slap on the wrist and sometimes not even that. (Johnson & Johnson disputes Harris’s claims. “We stand behind the safety of our products and are focused on what we do best: delivering medical innovation for patients around the world,” a spokeswoman said.)
‘What you see over time is that industry’s priorities become agency priorities.’
Holding drug makers to account for malfeasance has proved extremely difficult, Harris and others say. In many states, F.D.A.-approval offers protection against negligence claims or prevents juries from assessing punitive damages. In the case of Johnson & Johnson’s baby powder, hundreds of millions of dollars in judgments against the company have been repeatedly overturned on appeal. But if the price paid by industry has been small, the cost to the F.D.A. has not: By 2025, according to data from the Kaiser Family Foundation, less than half of all Americans said they trusted the agency to carry out its core responsibilities.
Well before that mistrust mushroomed into the MAHA movement or propelled a vaccine skeptic to the highest health office in the nation, F.D.A. watchdogs were fighting to restore the policies that had led to so many agency missteps.
Among other things, they were pressing for more judicious use of accelerated drug approvals; better safety monitoring of drugs that made it to market; far more rigorous follow-up studies for drugs approved with incomplete data; and, perhaps most important, an end to the user fees that now accounted for roughly half the agency’s overall budget. “The F.D.A. meets with industry hundreds of times over the user-fee renewals, and only half a dozen or so times with the rest of us,” Reshma Ramachandran, a physician and a co-director of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency, or CRITT, told me. “Whether it’s conscious or deliberate or not, what you see over time is that industry’s priorities become agency priorities.”
Along with her colleagues, Ramachandran submitted public comments to the agency, spoke at drug-approval hearings, met with lawmakers and conducted her own research on the effects of agency policies. What she most wanted regulators and their congressional overseers to understand was this: approving drugs quickly and with less evidence might give doctors and patients more options, but it also shifted a huge burden of uncertainty from the agency onto them.
She remembered feeling hopeful at the end of the Biden administration. Policymakers had expressed interest in their proposal for a publicly funded clinical-trial program, and at least some members of Congress had been receptive to their warnings about the dangers of ever-lower approval standards. But as a new administration took control of the agency, she and her colleagues sensed that their measured pleas for smart, scalpel-level reforms would now be drowned out by the sound of sledgehammers.
On March 27, a few days before the F.D.A.’s 27th commissioner, Martin Makary, was sworn in, Kennedy announced he would fire about 10,000 civil servants from the Department of Health and Human Services. The Food and Drug Administration would face heavy losses: 3,500 terminations in all, or 20 percent of its work force. Those layoffs were temporarily blocked by a federal judge on July 1, who said the mass firings exceeded the health secretary’s authority and were most likely illegal. But the damage was done. The offices for medical devices, tobacco products and generic drugs were all but eviscerated. The agency’s library was shuttered and subscriptions to key scientific journals canceled. Administrative staff across the agency was cut to the bone. “Dr. Makary was brought in to clean up an F.D.A. plagued by bloated bureaucracy, unaccountable leadership and regulatory capture,” says Andrew Nixon, director of communications at H.H.S. “Under his watch, the agency is finally returning to evidence-based science, speed and public service.”
A couple of weeks later, Kennedy made his first in-person visit to agency headquarters. In a speech broadcast from a private room to a large hall where the agency’s staff had gathered, he doubled down on the sentiments expressed in his October post. The Deep State was real, he said. And the F.D.A. was a mere industry “sock puppet.”
At first blush, Kennedy’s remarks appeared to dovetail with the critiques leveled by experts like Ramachandran. So many of the F.D.A.’s missteps seemed — to both agency watchdogs and the MAHA faithful — to come down to the undue influence of industry over the institution. But where Kennedy and his ilk saw conspiracy or corruption, Ramachandran and other watchdogs saw something far more complicated. For one thing, 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.
‘How can people have such divergent views of what the agency is trying to do?’
Lurie, a doctor who spent years challenging the agency from his perch at the nonprofit Public Citizen, remembers how his perception of the F.D.A. changed once he became a deputy commissioner under President Barack Obama. “I thought, Well, you know, this agency is just completely captured by industry, and I’m going to stand up for, you know, what’s good and right in the world,” he told me. “But that’s a misunderstanding of the way that government actually works.” Most of the meetings he attended, he says, involved smart people trying to achieve shared objectives. Political ideologies or feelings about industry never came up at all and would not have mattered if they did.
Mitch Zeller, who worked at the Center for Science in the Public Interest before leading the F.D.A.’s tobacco division, described a similar acclimation process for the dozen or so political appointees who joined the agency during the first Trump administration. They quickly came around to the agency and its mission, he said. When there was pressure on Zeller to exempt premium cigars from a series of new regulations, something he considered both illegal and bad for public health, the appointees ran interference so that he could prevail.
The F.D.A.’s real problem, Lurie and others suggested, 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.”
This was brought home to Sharfstein when he led the Obama administration’s F.D.A. transition team. He was meeting with interest group after interest group — a dizzying ritual, not unlike speed dating — when he realized two things: Everyone, regardless of whom they represented (industry, patients, doctors, consumers), hated the F.D.A. And different organizations often had the exact opposite idea of what regulators were doing wrong and why. If one group said that the agency was too slow or that people were dying for want of cures while bureaucrats dotted I’s and crossed T’s, the next would accuse them of rushing products to market without sufficient regard for safety or effectiveness.
“I thought, How can people have such wildly divergent views about what the agency is intending and trying to do?” he told me. “And then someone said that, ‘You know, it would really help a lot if the F.D.A. explained itself.’” Sharfstein and his team did their best to heed that advice. They published detailed explanations of their decisions, convened a task force and created an agencywide transparency initiative that included making key documents on drug approvals and rejections publicly available. The idea was well received. Venture capitalists said they would be more likely to invest in risky biotech innovations if they could hear directly from regulators, instead of being forced to take the word of industry executives. And watchdog groups said that releasing more information would help build trust — and dispel medical conspiracy theories.
When the pandemic hit, few of those proposals had been implemented. “You have these stories of people filing FOIA requests at the F.D.A. for vaccine data” — on Covid-19 vaccines — “and the F.D.A. telling them it would take 55 years to respond,” Christopher Morten, director of the Science, Health and Information Clinic at New York University School of Law, told me. “That becomes a story unto itself, that the F.D.A. is, quote unquote, hiding data from the public. Conspiracy theorists seize on that.”
Morten and other watchdogs view transparency as a key to the F.D.A.’s salvation. Janet Woodcock, who spent almost 40 years as one of the agency’s top drug regulators before retiring in 2024, is far less sanguine. Woodcock has been heavily criticized for her role in regulating several controversial drugs, including OxyContin, the now discontinued Alzheimer’s drug Aduhelm and Exondys 51, a treatment for Duchenne muscular dystrophy that the F.D.A.’s own reviewers urged the agency to reject. In June, a ProPublica investigation also faulted Woodcock for allowing factories in India and elsewhere to send generic drugs to the United States through a secretive exemption process, despite serious safety violations, including filthy laboratories and contaminated products.
She stood by all those decisions, she told me. It was easy to single out missteps, but the F.D.A. made hundreds of complex decisions every day, and each one came with benefits and trade-offs. The risk posed by a substandard factory, for example, had to be weighed against the prospect of major drug shortages, including of medications that treat cancer in children. And the downsides to approving a drug whose benefits appeared to be minimal had to be viewed in light of the patients who were facing certain death. Regulators like her did a pretty good job balancing those concerns, she insisted, especially relative to the resources at their disposal.
More transparency might improve trust, she went on. But it was much more likely to provide bad-faith actors with further ammunition for their attacks on the agency. “I’ve gotten emails saying that I was committing crimes against humanity for not approving certain products fast enough,” she said. “And then you know, messages saying I’d be tried at Nuremberg once that same product was approved. We get blamed for everything, on all sides. Releasing more documents isn’t going to fix that.”
That defensive crouch might have insulated Woodcock and her colleagues from the vagaries of public opinion, but it also made them uniquely vulnerable to current attacks, which increasingly appeared to spell the agency’s doom.
As the first 100 days of the new administration ticked along, watchdogs and institutionalists alike found themselves caught up in a vast retrenching. Rather than working to make the F.D.A. stronger, many were suddenly — strangely — defending things that they previously criticized and balking at things they previously argued for. Their positions hadn’t changed. But that the new administration’s solutions to the agency’s intractable problems were even worse than the problems themselves.
‘What they appear poised to do is to pack the advisory committees with their cronies.’
Those who had opposed industry-paid user fees because they undermined the F.D.A.’s credibility or independence now found themselves praying that the system remained intact, because problematic funding was better than no funding at all. Those pushing transparency initiatives now cringed to hear the new health secretary talk about “radical transparency,” because it seemed to mean something very different to him than it did to them: not an honest and impartial sharing of information but a scorched-earth search for something — anything — that would bolster dangerous and disproven theories. And those who for years complained that the F.D.A. was shutting out advisory committees (outside experts who consult with the agency on product approvals) were now worried that they would take their recommendations to heart.
“What they appear poised to do is to pack the advisory committees with their cronies and make the process even less credible than it stands right now,” Aaron Kesselheim, a professor at Harvard Medical School and a former advisory committee member, told me recently. Doctors and scientists who criticized the F.D.A. for ignoring advisory committees when it came to Alzheimer’s drugs would now be complaining about the exact opposite: abiding by the advisory committee when it came to, say, pulling polio vaccines off the market. They would be dismissed as hypocrites, he speculated. And the truth — that the committees themselves had been radically altered — would be lost in the noise.
In the meantime, Ramachandran and her colleagues were trying to hold the line wherever they could. When administration officials began removing troves of vital health information from various federal websites this winter, they filed a lawsuit and won a temporary restraining order. After mass firings all but eliminated public-information offices at the F.D.A., Ramachandran contemplated filing more lawsuits: Could they sue under the Freedom of Information Act, if their information requests were delayed for too long? What about the secretary’s plan to eliminate public comments in certain cases? Could they challenge that proposal in court?
It was impossible to say how much worse things would get — how many more people would be fired, policies rescinded or projects canceled — or what if anything would be preserved from the preceding era. David Kessler, who served as F.D.A. commissioner during both the George H. W. Bush and Clinton administrations, thought the core tenets of drug regulation would endure, in part because the success of American industry hinged on those tenets. “There were debates decades ago about removing the efficacy standards, but no one credible is making that argument today,” he told me in March. “Global competitiveness is based on the fact that when a drug is approved in the U.S., it does what’s said on the label.”
But most of the two dozen or so other experts I spoke with disagreed. “They’ve already perverted the law,” Joseph Ross, a professor of medicine at Yale and co-director of CRITT, the Yale watchdog group, told me. “The idea that they’re going to make it even worse is, I think, a very real one.”
After so many years of antagonism, those who spent their careers fighting with and for the agency seemed to agree that something vital was slipping away. What good were transparency initiatives, they 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.”
Kennedy’s disdain for the F.D.A. was clear, but as far as Califf, who retired from the agency on Jan. 20, could tell, the health secretary’s vision for the agency’s future remained muddy. He seemed to want to challenge the consensus on well-proven medicine (like M.M.R. vaccines, fluoridated drinking water and the abortion pill mifepristone) but also to unleash a catalog of products with little to no evidence behind them, including cod-liver oil for measles and chelating compounds, which remove metal from the blood, for autism. He insisted that “gold standard” science, including randomized controlled clinical trials, should guide the nation’s health policies. But he rejected any study that contradicted his stated views or the views of his supporters (including that vaccines cause autism); he accepted any study that supported those positions, regardless of its quality or scope; and he dodged or outright ignored anyone who pointed out the glaring contradiction.
‘They’ve already perverted the law. The idea that they’re going to make it even worse is a very real one.’
Watchdogs and institutionalists alike seethed with frustration. Did the health secretary want more regulation or less? What was his overarching philosophy? How could any agency possibly accommodate so many paradoxes? But whatever the weakness of Kennedy’s logic, his arguments had a sort of strategic brilliance to them. By insisting that the agency was corrupt, he could marshal both sides of a longstanding divide — those who wanted stronger regulations and those who wanted none — to his own cause. If the F.D.A. was down-to-its-bones wrong, then anything Kennedy said against the agency was right, no matter how contradictory or confused. Did regulations need to be stricter or more lenient? The answer was yes. The unifying principle was him.
In late April, Kennedy announced plans to eliminate synthetic, petroleum-based dyes from the human food supply. He seemed to brush past all the strictures that, in Califf’s experience, made slow and difficult work of such seemingly simple goals. In fact, he spoke as if the agency itself were superfluous and meaningful change could be achieved by fiat. When reporters asked why no industry representatives had attended the briefing and whether any of them supported the plan, he shrugged the question off. “We don’t have an agreement,” he said. “We have an understanding.” He did not mention — and perhaps did not know — that the food and beverage industry had made similarly vague promises in the past, to no avail, or that neither he nor the F.D.A. had the authority to compel companies to comply with the new directive or to punish them if they didn’t.
By May, Kennedy and his deputies were taking direct aim at vaccines. They announced that new clinical trials would be required for Covid boosters, even though the shots have long been considered both safe and effective. At the C.D.C., Kennedy himself would soon fire the entire 17-person expert committee that advises federal health officials on vaccine recommendations (not whether shots should be approved, but who should receive them). Their replacements — eight people with little to no relevant expertise and some with obvious conflicts of interest — quickly revoked the government’s longstanding recommendation of a subset of flu vaccines that contain the preservative thimerosal. Vaccine skeptics suspect the preservative of causing autism, despite numerous studies showing the compound to be harmless.
One thing that appeared not to have changed was the F.D.A.’s relationship with drug makers. In June, Makary and his deputies began a six-city listening tour with drug-industry executives that was, despite all the talk of radical transparency, closed to the public. (According to Nixon, the communications director at H.H.S., the tour was focused on industry stakeholders, and public transparency would be preserved through other forums.) Later that month, Makary announced a voucher program that would shorten drug review times from 10 to 12 months to just one or two for companies whose products met certain criteria. He also laid out a new list of agency priorities in The Journal of the American Medical Association that, for drugs, seemed to come down to two things: faster reviews and more approvals. “Their paper reads like it’s straight from pharma’s playbook,” Ramachandran told me. “They criticized expedited drug reviews for years, especially with respect to Covid vaccines, saying that it turned the F.D.A. into a rubber stamp. But now they want to do the exact same thing for as many other drugs as possible.”
Reports from inside the agency remained bleak. Some of the civil servants fired in February and April were now being invited back (the office of generic drugs had been reinstated), but most were not. Those who remained were being asked to volunteer for essential tasks for which there was now no dedicated staff. Scientists and technicians still did not have ready access to the scientific journals they needed to do their work. More than one drug review had been delayed, and political appointees had interfered in several others. And, ultimately, Vinay Prasad, the agency’s new chief medical and scientific officer, overrode expert recommendations on the Novavax and Moderna Covid-19 boosters slated for this fall. As expected — and perhaps as intended — many of the F.D.A.’s remaining employees were now looking for jobs outside the government.
Califf was not so much surprised by those developments as saddened. 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.”
Jeneen Interlandi writes about health and science for Opinion and is a staff writer at The New York Times Magazine. She writes primarily about public health.
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