Upending the U.S. watchdog on food and drugs

The Food and Drug Administration is one of the most consequential oversight bodies in the U.S. government. It has dramatic effects on regular folks’ lives, with its authority over industries that account for more than 25% of consumer spending — more than $1 trillion annually.

But exactly how should those in charge of the behemoth health agency fix what all sides recognize as significant problems at the FDA?

The current administration — under health secretary Robert F. Kennedy Jr. and his hand-picked FDA chief, Dr. Marty Makary (shown above, left) — has started trying to change the agency. This launch has been rocky, at best. Dissenting voices are rising, saying the agency is faltering, or even in chaos, in carrying out its vital role of ensuring the quality and safety of the nation’s food, prescription medicines, vaccines, medical devices, and more.

The agency’s latest controversies start at the top of the Health and Human Services department. RFK Jr., as previous newsletters have detailed, has shown himself to be obsessed with conspiracy theories about myriad health matters. The health secretary has embraced anti-science views and cherry-picked or adopted extreme or debunked medical studies. A lawyer and paid opponent of vaccines, he had no experience in running anything as big and influential as HHS, which includes the FDA and the Centers for Disease Control and Prevention — an agency he already has bulldozed. The health secretary has expressed open hostility for the FDA and its experts.

As Kennedy chose his key lieutenants to lead important federal health programs, he relied on anti-vaccine allies or cronies. He also elevated what might best be described as medical mavericks. These credentialed experts, like Makary, are finding that espousing contrarian views is one thing in academic medicine or published studies. It is another matter when dealing with extremist chiefs, thorny bureaucracies, cranky politicians, powerful industries, and big, noisy groups of real folks — patients, their loved ones, and advocates. The alarms sounding about the FDA are mostly coming from within for now, as the GOP-controlled Congress doesn’t seem to have much energy for common-sense governmental oversight. Still, with lives and the public’s health at stake, the tumult at the FDA demands voters’ attention.

Photo credit: the federal Food and Drug Administration

Draconian slashes in budgets and resources for FDA and other HHS agencies started a year ago at this time, in the name of government efficiency as dreamed up by the chain-saw-wielding multi-billionaire Elon Musk and his youthful “DOGE” minions.

HHS has now found that the mass dismissals were bungled sufficiently that hundreds of experienced personnel had to be rehired. This has occurred even as Kennedy, once in office, has ordered even more dismissals and big reductions in budgets.

Cut first, ask questions later

Critics say the administration’s cut-first, ask-questions-later approach harmed a vital FDA role: its inspections and oversight of food and prescription medications. This country has grown reliant — as the coronavirus pandemic drove home so painfully — on global supply chains. Both food and drugs pour into this country from growers, makers, and other vendors all across the planet. The FDA has struggled to keep up with global trends, most notably in inspecting facilities overseas. These sites operate in environments less regulated and officially supervised than would be common in this country.

With an already aging workforce, the FDA also has failed to keep up with the hiring necessary to maintain its existing food inspection force, much less to expand it to meet modern demand, according to Stat, a health and medical news site. Stat quoted experts like Sarah Sorscher, director of regulatory affairs at the consumer advocacy group Center for Science in the Public Interest:

“There was already a chronic shortage of food inspectors at the FDA and the Department of Agriculture, said Barbara Kowalcyk, director of the Institute for Food Safety and Nutrition Security at George Washington University. Now morale is low, experienced inspectors are retiring or leaving for the private sector, and the people who remain are overextended. ‘The staffing losses and the brain drain is huge, said Sorscher. ‘The inspection is only as good as the person doing it, and we’re losing so many experienced staff.’ The FDA food inspection workforce is about 20% understaffed, with 470 out of a ceiling of 589 positions filled, the agency [has] told consumer groups … The infant formula team has only 5 inspector positions filled out of 10, though there are 11 traditional inspectors who can also examine facilities. There’s no hiring freeze on inspectors — the problem is recruiting and retaining staff.”

The DOGE kids, and now RFK Jr.’s outsider leaders at the FDA, have targeted support staff for cuts at the agency, Stat reported. They have demonized these individuals and asserted that their employment was wasteful bloat. They could not be more wrong, Daniel Jernigan, who worked at the CDC for 30 years before resigning from his position as head of the agency’s National Center for Emerging and Zoonotic Infectious Diseases, told Stat:

“65% of support staff charged with tasks like booking and reimbursing travel were eliminated, he and others report. They say that expert inspectors’ valuable time gets devoured trying to arrange visas, travel, hotels, translators, and other logistics for site visits, with many more locales now in far-flung and non-English-speaking spots.

Who’s safeguarding drug-making overseas?

The lack of support staff and badly lagging hiring has hit drug inspectors, too, reported ProPublica, a Pulitzer Prize-winning investigative site:

“Beyond the staff cuts, the departures of some longtime investigators and leaders in recent months have left less experienced people tasked with rooting out dangerous and sometimes deceptive manufacturing practices. The investigative unit, which looks into potential safety issues with drugs, vaccines, medical devices and other products, has had a retention problem for years. Inspectors leave so often that even with hiring blitzes, the FDA has been unable to get ahead. Between 2022 and 2024, the agency hired 105 inspectors but about the same number left, leaving the inspection pool with about 230 people, according to the Government Accountability Office, the watchdog arm of Congress. About one-third did not have the experience to conduct independent foreign inspections, the GAO found. Two FDA inspectors said the agency needs an additional 100 to 200 experienced investigators to do the work. The job can be grueling. Some inspectors who travel to overseas drug-making factories can be away for as long as 15 weeks a year. Some have described threats of violence by company managers, days on planes and trains in oppressive heat and long nights preparing inspection reports before they head to the next stop.”

The drug inspectors’ work cannot be underestimated, ProPublica reported:

“For years, inspectors have uncovered dirty equipment, contaminated supplies and fraudulent testing records in some overseas factories — serious safety and quality breaches that can sicken or kill consumers … ProPublica [recently] reported that a generic immunosuppression drug for transplant patients could dissolve too quickly when ingested, increasing the risk of kidney failure. The drug was made at an Indian factory with a history of quality violations that was banned from the U.S. market. The company previously told ProPublica it believes the medication is safe.”

Damage piles up with cuts in other agencies

In the United States, the administration-ordered cuts to the food inspections came with another blow to safety with deep cuts in a program at the Centers for Disease Control and Prevention (CDC) that worked with the FDA and state officials, Stat reported:

“One significant area of concern is the Trump administration’s decision to scale back the Foodborne Diseases Active Surveillance Network, or FoodNet, program, reducing the number of pathogens in its reporting requirements from eight to two — salmonella and E. coli. Ten state health departments participate in the FoodNet program, which surveys about 16% of the U.S. population with the goal of detecting outbreaks early and tracking down their sources. The CDC cited funding issues as a reason for the change and said that other CDC systems also conduct national surveillance for the pathogens. ‘Narrowing FoodNet’s reporting requirements and associated activities will allow FoodNet staff to prioritize core activities,’ a CDC spokesperson told STAT. But experts said that what makes FoodNet unique is that it conducts active surveillance, reaching out to state laboratories to ask about cases, rather than passively relying on states to notify the CDC about illness. ‘FoodNet is ‘the best measure we have for whether the system is working or failing us,’ said Sorscher. ‘So the fact that they cut that first is just really dark.’ With FoodNet cuts, Sorscher said, ‘what’s being lost is accuracy and the ability to compare [trends] over time.’ ”

Via the CDC and the FDA, states and educators formerly received invaluable financial resources — mostly grants — that the administration has slashed. These allowed universities to educate and train more students to become food or drug inspectors and other experts in these fields. The money also supported state programs that bolstered frontline inspectors and their work, for example, by funding molecular analyses in situations involving tainted foods, linking individual cases so outbreaks could be detected faster, ProPublica reported.

The news site has found that the staff cuts and other agency turmoil have caused measurable harm to FDA food inspections. This finding moves the issue beyond carping, ProPublica reported, noting:

“American inspections of foreign food facilities — which produce everything from crawfish to cookies for the U.S. market — have plummeted to historic lows [in 2025], a ProPublica analysis of federal data shows, even as inspections reveal alarming conditions at some manufacturers … The stark reduction marks a dramatic shift in oversight at a time when the United States has never been more dependent on foreign food, which accounts for the vast majority of the nation’s seafood and more than half its fresh fruit. The stakes are high: Foreign products have been increasingly linked to outbreaks of food borne illness. In recent years, FDA investigators have uncovered disturbing lapses in facilities producing food bound for American supermarkets. In Indonesia, cookie factory workers hauled dough in soiled buckets. In China, seafood processors slid crawfish along cracked, stained conveyor belts. Investigators have reported crawling insects, dripping pipes and fake testing data purporting to show food products were pathogen free.”

Other points also are worth noting in the FDA cutbacks. They also hit hard at other important support services at the agency, including library and research staff, as well as those who worked in IT managing the FDA computer needs.

It is important to keep in mind that the current administration, in its first go-around, pushed hard on Big Food’s behalf to slash what officials deemed to be excessive regulation. This was the reason for officials’ first-term moves to allow meat, swine, and poultry plants to take on greater “self-policing” of their food-handling sites, as well as letting them increase the speed of processing lines. These actions increased risks to the nation’s food safety and quality, critics say.

By the way, if the administration argues that the FDA drug inspection issues will diminish due to efforts to prod Big Pharma to bring back to this country more product manufacturing from overseas, pragmatists offer a reality check: The complex plants needed for prescription drugs take anywhere from five to ten years to construct and get running. And even if drug manufacturing occurs stateside, important ingredients still must come from international suppliers whose operations require regulatory scrutiny.

Exactly how well does the FDA oversee two more pillars of its responsibilities — prescription drugs and vaccines?

Past criticisms included: Too slow. Too fast. Too beholden to Big Pharma. Too beholden to patients and their advocacy groups. Too swayed by money. Too unconcerned about value, especially cost vs. effectiveness. Now there’s a new complaint from inside the agency: politicization of FDA’s work.

In reviewing and deciding whether prescription drugs can be allowed on U.S. markets, critics say Makary — a surgeon, medical researcher and much-published author who formerly worked at Johns Hopkins — has risked his own professional reputation with his new plan for Big Pharma to enjoy a “Commissioner’s National Priority Voucher Program.” It would give drug makers an E-ticket to fast-track approval of products submitted to agency scrutiny, the AP reported:

“A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and outside experts, with some saying the poorly defined effort is taking key decisions away from career scientists and placing them in the hands of political leadership. The initiative by FDA Commissioner Marty Makary promises ultra-fast reviews for drugs that align with ‘U.S. national priorities.’ It’s at the center of Makary’s stated goal to ‘cut red tape’ and ‘challenge assumptions’ at the agency tasked with assuring the safety of food, medicines, medical devices and other consumer goods.

“But FDA staffers say the push for faster approvals is contributing to a climate of anxiety, fear and confusion within the agency’s drug center … Concerns about the legality of the program have also contributed to the recent departure of several leaders of the FDA drug center, which is now being led by its fifth director in the past year. FDA drug reviews have traditionally been handled by FDA career scientists who spend months analyzing data to determine whether drugs meet federal standards for safety and effectiveness. But the effort to truncate certain drug approvals has become intertwined with White House efforts to secure pricing concessions for drug makers, an unprecedented shift in the agency’s longstanding science-based approach that staffers fear could damage the FDA’s reputation and endanger patients.”

Significant and concerning

The AP says Makary’s proposed changes are significant and concerning:

“Giving final approval to a drug carries significant legal weight, essentially certifying the medicine’s safety and effectiveness meet FDA standards. If unexpected side effects or other problems later emerge, both the agency and individual officials could be pulled into investigations or lawsuits … Despite such concerns, the program remains popular at the White House, where pricing concessions announced by President Donald Trump, a Republican, have repeatedly been accompanied by FDA vouchers for drug makers that agree to cut their prices. For instance, when the White House announced that Eli Lilly and Novo Nordisk would reduce prices on their popular obesity drugs, FDA staffers had to scramble to vet and announce new vouchers for both companies in time for the press conference, according to multiple people involved in the process.

“That’s sparked widespread concern that FDA drug reviews have become malleable and open to political interference. FDA approval decisions have nearly always been handled by agency scientists and their immediate supervisors, rather than political appointees and senior leaders. But under the voucher program, approval comes through a committee vote by senior agency officials, according to multiple people familiar with the situation. Staff reviewers [with demonstrated expertise] don’t get a vote. Current and former staffers say the new approach flips FDA precedent on its head, minimizing the input of FDA scientists who have the greatest expertise and familiarity with the drug safety and effectiveness data.”

The FDA director’s voucher plan has been further complicated by Makary’s plain problems in finding leaders for key posts in the agency. (See sidebar).

Changing chiefs and vaccine opposition

These were only magnified by sharp criticism of how the FDA says it will conduct vaccine oversight.

Makary was under scrutiny already for how he would handle FDA oversight of vaccines, given the conspiracy-laden opposition to immunizations by his boss, RFK Jr.

In his confirmation testimony, Makary said he values and supports vaccines. Those comments raised eyebrows because the doctor had been an outspoken critic of how the Biden Administration rolled out the game-changing MRNA vaccinations against the coronavirus.

Makary hasn’t quieted critics by appointing as one of his chief agency deputies Dr. Vinay Prasad, who came to the FDA from the University of California, San Francisco. Prasad long has been a harsh critic of the FDA, Big Pharma, and notably the makers of cancer-fighting drugs, which he has written cost too much and do too little.  During the pandemic, Prasad — who had become what one report called an academic “scold” — assailed the coronavirus vaccine and its rollout. He has always backed a tough — some say impossible — standard for meds proving their safety and effectiveness. He has demanded placebo controlled, randomized clinical trials (aka RCTs). Prasad has described his view with an acronym that includes a vulgarity, arguing: RCT or STFU. With vaccines, such tests could make them both exceedingly costly and impossibly slow to even to be considered for approval.

Prasad and another colleague — Dr. Tracey Beth Hoeg, a sports medicine expert, epidemiologist, and vaccine skeptic who was advising Makary on immunization policy — have been linked to a highly controversial official report. It tied multiple deaths to the coronavirus vaccine. As information about that document leaked, independent and respected medical scientists denounced the claim and demanded that the FDA publish the data and other information it used to make a claim about covid vaccine fatalities.

Prasad used his authority as chief medical and scientific officer at the FDA to throw a wrench into both coronavirus vaccines and a prescription drug already approved to treat a rare disease. He had excoriated the drug as too costly and ineffective before he joined the government. His vaccine comments and actions, in concert with sudden changes in vaccine policies unilaterally put in place by RFK Jr., prompted a significant protest from a dozen former top public health officials, as CNN reported:

“[I]n a letter published … in the New England Journal of Medicine, a dozen former FDA commissioners warned that the proposed changes would ‘upend core policies governing vaccine development and updates’ and ‘undermine the public interest.’ The proposed changes were motivated by unjustified assertions about the dangers of vaccines, the former commissioners wrote … ‘We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most,’ they wrote. The group consists of agency leaders who served under both Democratic and Republican administrations, with more than 35 years of combined oversight.”

Far-right critics, who expected the current administration and RFK Jr. to loosen drug regulation in the name of allowing patients to experiment with medications, were outraged by Prasad’s drug action. He withered under the attacks and left his post, only to be persuaded by Makary to return.

As for Hoeg, Makary elevated her at the end of 2025 to a post that has stunned those inside and out of the FDA, CBS News reported. She is now acting director of the Center for Drug Evaluation and Research (CDER), “which is responsible for evaluating new drugs and ensuring adequate supplies of existing ones.” The news article quoted a blind source, who observed:

“Putting Tracy Beth in charge is like dropping an atom bomb. It’s an extinction level event. Tracy Beth Høeg has never supervised a drug review, never has conducted a clinical trial. She doesn’t understand laws and regulations.”

Hand-picked director quits in weeks — and blasts the boss

Makary had sought to persuade Richard Pazdur, a respected and longtime FDA expert, to head up the crucial CDER. He took the job on condition that he could operate without political meddling, according to news reports. He retired a few weeks later. He since has blasted Makary, the voucher program, and the politicization of the FDA, the medical news site Stat reported:

“Richard Pazdur, a veteran regulator at the Food and Drug Administration who left the agency [recently] said the firewall between political appointees and drug reviewers at the agency ‘has been breached,’ and that there is not enough transparency around a new voucher program that grants accelerated review to certain drugs selected by Trump administration officials. Pazdur said meetings about drugs in the voucher program should be open to the public or at least to the FDA staff, but ‘at the present time, it’s being held in a conference room that is adjacent to the commissioner’s personal office. There’s not enough room in that office even for the entire review staff that has worked on that application to attend this meeting.’ ”

The Washington Post reported more detail about Pazdur’s criticisms: “Pazdur and Makary have disagreed over the commissioner’s plan to reduce the number of research studies needed to justify more drug-related decisions, such as changes to drug labels, two of the people said. Makary has argued that his plan to reduce the burden of proof to a single study would allow the agency to more quickly respond to new evidence. Pazdur has countered that multiple studies may be necessary in many cases and would better protect public health. Pazdur has also pushed back on Makary’s plans to exclude career scientists from matters that address political priorities, arguing that their involvement is essential to ensure a safe and transparent drug-review process, two people said. Makary has been seeking rapid changes to agency regulations that affect antidepressant medications, puberty blockers and psychedelics, among other priorities. The commissioner has also questioned whether some career scientists are impeding that agenda and should be reassigned …”

Will ignoring all this turmoil be an effective coping strategy for those of us who want unspoiled food and safe drugs, without having to worry about all the fuss?

As the FDA and its staff advance through the term of this current administration, perhaps the huge changes — in leadership as well as policies and practices — will settle down. Perhaps the churn among agency staff will calm and morale will improve. Even critics say that some of the FDA changes will improve this important regulatory work.

Still, the administration keeps boasting about slashing hundreds of thousands of staff from the federal government, arguing that colleagues of current employees were part of a scourge of waste, fraud, and abuse. The president — who pushed unproven prescription drugs for diseases, and talked about patients injecting bleach to deal with infections — theorized that many ousted government workers, especially those with top credentials and expertise, will go to private industry.

But the FDA and its elite workforce  — the highly trained and experienced experts who supposedly sought to protect patients — were taking heat for a revolving-door environment in which top regulators crossed over to big pay and benefits in the employ of Big Pharma. This transition, critics long have argued, mostly benefited big-spending drug makers and not the great many folks who take increasingly costly and less accessible prescription drugs.

A reminder that federal data show that “60% of adults aged 18 and over take at least one prescription drug, with 36% taking three or more.”

An agency with a positive and negative past

After more than a century in existence, it’s easy to take for granted a watchdog like the FDA. Many don’t know the early 20th century history that sparked the laws that set up the FDA, when nostrum peddlers once proliferated and poisoned customers without government intervention. In our own lifetimes, do students learn any more how the FDA kept the nightmare of thalidomide from harming pregnant moms and their unborn kids? Do consumers realize how U.S. health improved with the crackdown on tobacco by the FDA and other parts of the government?

The FDA, of course, also has its history of failures with drugs like the purported miscarriage-preventing medication diethylstilbestrol (DES), opioid painkillers, and the diet pills known as Fen Phen. The agency has labored since its inception to safeguard the nation’s food supplies. The country no longer has the sickening conditions in slaughterhouses and other food-handling sites, as once prevailed during the time of muckrakers like author Upton Sinclair. But food-borne illnesses persist as a major public health problem, including  important products like baby foods. The agency is watched around the globe for its attempts, at least, to regulate medical devices. Critics, though, have assailed the agency for allowing this regulatory area, which affects millions of patients, to become what medical journalist Jeanne Lenzer has called a new “wild, wild West.”

Patients on their own

If the shifts at the FDA keep going apace and do not show themselves beneficial to patients and consumers, perhaps the nation will enter a new period of heightened self-reliance. Folks will be more on their own, for example, worrying about finding good sources for their prescription meds and healthy foods.

It always pays for consumers to use care in choosing where we buy groceries. Even more caution may be the order of the day in the handling and preparation of home and commercial meals.

With foods and prescription drugs, purchasers will need to keep closer tabs on information about product problems and recalls. These may be issued more at the state and local level, especially by officials concerned about larger-scale issues with tainted products or illness outbreaks. Another reminder from federal data: 48 million Americans, roughly 1 in 6 people in this country, suffer food poisoning annually. This leads to 128,000 hospitalizations and 3,000 fatalities each year.

As always, patients should be consulting regularly with their doctors and pharmacists about the prescription meds, over-the-counter drugs, and supplements they are taking. Hospitals, clinics, and pharmacies may be forced to be even more active than they are now in letting patients know about potential problems with prescribed meds. That service may rise in importance partly because FDA staff responsible for communicating the agency’s work and findings to Congress and the public were among the staff let go in what the Atlantic magazine has described as a great government “purge.”

Ultimately, will the administration and the nation enjoy luck in avoiding crises related to prescription drugs or food? Will the cuts and changes promoted by health leaders in place now turn out to be a positive, needed reform of a much-criticized government operation? People’s health and lives are at stake, and voters need to keep up with what may seem to be Byzantine bureaucratic shifts so they can decide with their elected officials what the future brings.