F.D.A. Scientists Are Reinstated at Agency Food Safety Labs

After 20 percent of the agency’s work force was cut, federal health officials have decided to bring back some experts and review firings to fill gaps in critical roles.Federal health officials have reversed the decision to fire a few dozen scientists at the Food and Drug Administration’s food-safety labs, and say they are conducting a review to determine if other critical posts were cut.A spokesman for the Department of Health and Human Services confirmed the rehirings and said that several employees would also be restored to the offices that deal with Freedom of Information requests, an area that was nearly wiped out.In the last few months, roughly 3,500 F.D.A. jobs, about 20 percent, were eliminated, representing one of the largest work force reductions among all government agencies targeted by the Trump administration.The H.H.S. spokesman said those employees called back had been inadvertently fired because of inaccurate job classification codes.The decision to rehire specialists on outbreaks of food-related illnesses and those who study the safety of products like infant formula follows contradictory assertions made by Dr. Marty Makary, the F.D.A. commissioner, in media interviews this week.“I can tell you there were no cuts to scientists or inspectors,” Dr. Makary said Wednesday on CNN.In fact, scientists had been fired from several food and drug safety labs across the country, including in Puerto Rico, and from the veterinary division where bird flu safety work was underway. Scientists in the tobacco division who were dismissed in February — including some who studied the health effects of e-cigarettes — remain on paid leave and have not been tapped to return, according to employees who were put on leave.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Experts Doubt Kennedy’s Timetable for Finding the Cause of Autism

The nation’s health secretary announced that he planned to invite scientists to provide answers by September, but specialists consider that target date unrealistic.Robert F. Kennedy Jr., the nation’s health secretary, pledged on Thursday to seek out experts globally to discover the reasons for the increasing rates of autism in the United States.“We’ve launched a massive testing and research effort that’s going to involve hundreds of scientists from around the world,” Mr. Kennedy announced at a cabinet meeting held by President Trump. “By September, we will know what has caused the autism epidemic and we’ll be able to eliminate those exposures.”“There will be no bigger news conference than that,” Mr. Trump replied.But scientists who have worked for decades to find a cause greeted Mr. Kennedy’s predicted timeline with skepticism.They said that a single answer would be hard to identify in a field of possible contributors including pesticides, air pollution and maternal diabetes.Dr. Philip Landrigan, a pediatrician and expert on environmental toxins, pointed to the current mass layoffs and cutbacks for research at Mr. Kennedy’s Department of Health and Human Services as one reason for doubting such quick progress.“Given that a great deal of research on autism and other pediatric diseases in hospitals and medical schools is currently coming to a halt because of federal funding cuts from H.H.S.,” he said, “it is very difficult for me to imagine what profound scientific breakthrough could be achieved between now and September.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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FDA Layoffs Could Raise Drug Costs and Erode Food Safety

Trump cutbacks were supposedly aimed at administrators. But scientists in food and drug-testing labs and policy experts who advance generic drug approvals were also dismissed.Health Secretary Robert F. Kennedy Jr. announced wide-ranging cutbacks at federal health agencies, including the Food and Drug Administration, that would eliminate duplicative services and paper pushers.But in interviews with more than a dozen current and former F.D.A. staff members, a different picture emerged of the far-reaching effects of the layoffs that would ultimately reduce the agency work force by 20 percent. Among them are experts who navigated a maze of laws to determine if an expensive drug can be sold as a low-cost generic; lab scientists who tested food and drugs for contaminants or deadly bacteria; veterinary division specialists investigating bird flu transmission; and researchers who monitored televised ads for false claims about prescription drugs.In many areas of the F.D.A., no employees remain to process payroll, to file retirement or layoff paperwork and to help overseas inspectors who are at risk of maxing out agency credit cards. Even the agency’s library, where researchers and experts relied on medical journal subscriptions that have now been canceled, has been shut down.The F.D.A.’s new commissioner, Dr. Marty Makary, showed up for a long-awaited appearance at the agency’s Maryland headquarters on Wednesday. He delivered a speech outlining broad problems in the health care system, including a rise in chronic diseases. Employees were not given a formal opportunity to ask questions.About 3,500 F.D.A. employees are expected to lose their jobs under the reductions. A spokesman for Health and Human Services did not respond to questions.When the Trump administration executed its first round of cuts to the F.D.A. in February, it gutted teams of scientists who did the delicate work of ensuring the safety of surgical robots and devices that infuse insulin in children with diabetes. Some of the layoffs and cutbacks, described by former F.D.A. officials as arbitrary, were rapidly reversed.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Federal Health Workers Make Up Less Than 1% of Agency Spending

A few days ago, Robert F. Kennedy Jr., the health secretary, embarked on a media tour to defend his decision to lay off thousands of his department’s workers.He announced a plan last week to cut 10,000 jobs, in addition to the estimated 10,000 jobs cut through retirements and buyouts in the early weeks of the Trump administration.Mr. Kennedy had called the Health and Human Services Department “the biggest agency in government, twice the size of the Pentagon, $1.9 trillion dollars,” during an interview with NewsNation. He went on to suggest that the department was doing little to improve the health of Americans, “with all the money that was being thrown at it, with all the personnel that were being brought in.”H.H.S. does spend more than the Department of Defense, which has a discretionary budget of about $850 billion. But according to several budget experts, the overwhelming majority of the H.H.S. department’s $1.8 trillion budget is not spent on its staff.Spending on personnel at the federal health agencies accounts for a small fraction of its budget — less than 1 percent, according to three budget experts. That includes the staff of the Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health and others.The overwhelming majority of the money is spent through Medicare, for the health care of people older than 65, or through Medicaid, for people with low incomes. Those funds filter out to hospitals, clinics, nursing homes, dialysis centers, pharmaceutical companies, medical device makers and Medicare Advantage private insurance plans.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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FDA-Approved Artificial Blood Vessel Stirs Concerns

The F.D.A. approved an artificial vessel to restore blood flow in patients, despite its own scientists flagging questionable study results and potentially fatal ruptures of the product.When the biotech company Humacyte designed a study to see if its lab-grown blood vessel worked, it decided to measure whether blood was flowing freely through the high-tech tube 30 days after it was implanted in a person.As those days passed, some of the 54 patients in the study ran into trouble. Doctors lost track of one. Four died. Four more had a limb amputated, including one who developed a clot and infection in the artificial vessel, Food and Drug Administration records show.Humacyte, which is traded on the Nasdaq, counted all those patients as proof of success in talks with investors and in an article in JAMA Surgery.At the F.D.A., though, scientists counted the deaths, amputations and the lost case as failures, records show, noting a lack of information to determine if the vessels were clear.Still, the agency approved the vessels in December without a public review of the study. Top officials authorized it over the concerns of staff members who said in F.D.A. records that they found the study severely lacking or were alarmed by the dire consequences for patients when the vessels fell apart.Now the company is ramping up its marketing efforts to hospitals and for use on the battlefield.When a patient’s blood vessel is damaged, doctors typically find a blood vessel from another part of the body and graft it to repair blood flow. They turn to artificial vessels when patients are too badly injured to harvest a vein.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Trump Administration Delays Requirement for Companies to Track Tainted Food

A law passed in 2011 required food companies to track food in the event of contamination and a recall. The administration delayed the move, set to take effect next year, for 30 months.The Food and Drug Administration said on Thursday that it would delay by 30 months a requirement that food companies and grocers rapidly trace contaminated food through the supply chain and pull it off the shelves.Intended to “limit food-borne illness and death,” the rule required companies and individuals to maintain better records to identify where foods are grown, packed, processed or manufactured. It was set to go into effect in January 2026 as part of a landmark food safety law passed in 2011, and was advanced during President Trump’s first term.Robert F. Kennedy Jr., the health secretary, has expressed interest in chemical safety in food, moving to ban food dyes and on Thursday debuting a public database where people can track toxins in foods. But other actions in the first months of the Trump administration have undercut efforts to tackle bacteria and other contaminants in food that have sickened people. The administration’s cutbacks included shutting down the work of a key food-safety committee and freezing the spending on credit cards of scientists doing routine tests to detect pathogens in food.There were several high-profile outbreaks in recent years, including the cases last year linked to deadly listeria in Boar’s Head meat and E. coli in onions on McDonald’s Quarter Pounders.The postponement raised alarms among some advocacy organizations on Thursday.“This decision is extremely disappointing and puts consumers at risk of getting sick from unsafe food because a small segment of the industry pushed for delay, despite having 15 years to prepare,” said Brian Ronholm, director of food policy at Consumer Reports, an advocacy group.Many retailers have already taken the steps to comply with the rule. Still, trade groups for the food industry lobbied to delay implementation of the rule in December, according to The Los Angeles Times.In a letter to President Trump in December, food makers and other corporate trade groups cited a number of regulations that they said were “strangling our economy.” They asked for the food traceability rule to be pared back and delayed.“This is a huge step backward for food safety,” said Sarah Sorscher, director of regulatory affairs at the Center for Science in the Public Interest, an advocacy group. “What’s so surprising about it is this was a bipartisan rule.”Ms. Sorscher said there was broad support for the measure, since it would protect consumers and businesses, which could limit the harm, the reputational damage and the cost of a food recall with a high-tech supply chain.

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Food Safety Jeopardized by Onslaught of Funding and Staff Cuts

The Trump administration halted some food testing and shut down a committee studying bacteria in infant formula. Earlier funding cutbacks under the Biden administration now threaten state labs and inspectors.In the last few years, foodborne pathogens have had devastating consequences that alarmed the public. Bacteria in infant formula sickened babies. Deli meat ridden with listeria killed 10 people and led to 60 hospitalizations in 19 states. Lead-laden applesauce pouches poisoned young children.In each outbreak, state and federal officials connected the dots from each sick person to a tainted product and ensured the recalled food was pulled off the shelves.Some of those employees and their specific roles in ending outbreaks are now threatened by Trump administration measures to increase government efficiency, which come on top of cuts already being made by the Food and Drug Administration’s chronically underfunded food division.Like the food safety system itself, the cutbacks and new administrative hurdles are spread across an array of federal and state agencies.At the Food and Drug Administration, freezes on government credit card spending ordered by the Trump administration have impeded staff members from buying food to perform routine tests for deadly bacteria. In states, a $34 million cut by the F.D.A. could reduce the number of employees who ensure that tainted products — like tin pouches of lead-laden applesauce sold in 2023 — are tested in labs and taken off store shelves. F.D.A. staff members are also bracing for further Trump administration personnel reductions.And at the Agriculture Department, a committee studying deadly bacteria was recently disbanded, even as it was developing advice on how to better target pathogens that can shut down the kidneys. Committee members were also devising an education plan for new parents on bacteria that can live in powdered infant formula. “Further work on your report and recommendations will be prohibited,” read a Trump administration email to the committee members.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Senators Press Marty Makary on Abortion Pills and Vaccines

At a hearing, Dr. Marty Makary, the nominee for F.D.A. commissioner, fielded questions focused on whether he would review or reopen certain policy areas.At a confirmation hearing for Dr. Marty Makary on Thursday, senators focused heavily on the safety of the abortion pill, with Republican lawmakers urging him to restrict access and Democratic lawmakers demanding that he maintain its current availability.Dr. Makary, President Trump’s nominee to lead the Food and Drug Administration, signaled that he shared Republicans’ concerns about the current policy, issued during the Biden administration, which expanded access by allowing people to obtain the pills without an in-person medical appointment.Several Democrats pointed to volumes of studies showing that the drugs are safe. Dr. Makary told members of the Senate health committee, which held the hearing, that he would review the pill’s safety and the policy at issue.He said he would “take a solid, hard look at the data and to meet with the professional career scientists who have reviewed the data at the F.D.A. and to build an expert coalition to review the ongoing data, which is required to be collected.”The hearing also touched on vaccines, with several lawmakers, including the committee chairman, Senator Bill Cassidy, Republican of Louisiana, questioning why an advisory committee meeting on next year’s flu vaccine had been canceled in recent weeks and asking whether it would be held later. He and others stressed that the flu panel met annually, and some reminded Dr. Makary that Robert F. Kennedy Jr., who oversees the F.D.A. as health secretary, had pledged transparency in agency decision-making.Senator Patty Murray, Democrat of Washington, called the cancellation “unprecedented and dangerous” after decades of annual meetings.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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F.D.A. Nominee to Face Grilling Over Cutbacks and Policy Shifts

Dr. Marty Makary will testify before the Senate health committee on Thursday. Lawmakers may press him over staff reductions and changes in agency direction on issues like vaccines.Dr. Marty Makary may face sharp questions from senators about whether he will defend the Food and Drug Administration against staff cutbacks and industry pressure on Thursday, although he is still expected to sail through his confirmation hearing to become the agency’s commissioner.Dr. Makary built his reputation as a contrarian in the medical field, gaining widespread notice by speaking out about medical errors. Those close to him have remarked on his willingness to agree with Robert F. Kennedy Jr., the nation’s health secretary, on a variety of issues.As a pancreatic cancer surgeon and health policy researcher at Johns Hopkins University, Dr. Makary has been viewed by some as a study in contrasts. He has written several books criticizing what he considers flaws in medical orthodoxy that result in recommendations backed by scant evidence.Yet he also drew attention from the Trump team as a Fox News personality with more controversial views, like his relatively early predictions that Covid would fade as a concern and that widespread immunity would take hold long before it did.Dr. Reshma Ramachandran, an assistant professor at the Yale School of Medicine, said that it was not clear which is the “true Marty Makary.”She said that was an important question, given some of Mr. Kennedy’s pronouncements. The health secretary has suggested that the F.D.A. should lift constraints on risky products like raw milk, which can be rife with bacteria, and had embraced hydroxychloroquine, a drug briefly used as a Covid therapy before its risks were deemed to exceed any benefit.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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He Fought Claims of Harm From Infant Formula. Now He Regulates It.

Kyle Diamantas, a former corporate lawyer, is the new director for the F.D.A. food division, which oversees infant formula. He defended a top maker in cases claiming the company had not warned of potential risks to very low-weight babies.The new head of the Food and Drug Administration division that regulates infant formula was in recent months a corporate lawyer defending a top formula maker from claims that its product gave rise to debilitating harm to premature babies.Kyle A. Diamantas joined the F.D.A. last month to lead the food division, leaving the law firm Jones Day, which has served as a pipeline of talent to both Trump administrations.As a partner in Jones Day’s Miami office, Mr. Diamantas’s recent work included defending Abbott Laboratories in lawsuits accusing the company of failing to adequately warn parents that its specialized formula for premature infants was associated with an elevated risk of a deadly bowel condition.Abbott lost the case and was ordered to pay $495 million. Abbott is appealing the verdict. Mr. Diamantas’s role in the Abbott cases has not been previously reported.The leader of the F.D.A.’s food division has a wide-ranging role in ensuring the safety of about 80 percent of the food supply in the United States. In that job, Mr. Diamantas is also expected to take a lead role in enacting Health Secretary Robert F. Kennedy Jr.’s agenda, which calls for reducing additives in food and eliminating what Mr. Kennedy has described as corruption in public health agencies.“We will shut the revolving door to re-establish public trust,” Mr. Kennedy told the Health and Human Services Department’s staff during his first week in office.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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