F.D.A. Reinstates Fired Medical Device, Food and Legal Staffers

The Food and Drug Administration has reinstated dozens of specialized employees involved in food safety, review of medical devices and other areas who were laid off last week, according to more than a dozen workers who got called back.The total number of employees recalled was not immediately clear. But a person familiar with the conversations said nearly all of the roughly 180 medical division employees who had been let go would get their jobs back. More than a dozen workers across a handful of teams said that they had received a call or email reinstating their employment; some reported that up to a dozen others on their teams had also been brought back.The F.D.A. and its parent agency, the Department of Health and Human Services, did not respond to requests for comment.The workers had been fired as part of the Trump administration’s efforts, led by Elon Musk, to significantly downsize the federal government and cut costs. But the salaries of many of the fired F.D.A. staff members had been funded by fees companies pay the F.D.A., not taxpayer money.Many of the reinstated jobs were financed by those kinds of fees, but some such employees were still out of work. Those whose job were funded by an excise tax on cigarettes, for example, said they were not called back to work over the weekend. Those workers reviewed applications for new tobacco products and studied the safety of emerging tobacco products, including e-cigarettes and devices that heat up tobacco but do not burn it.On Friday, The New York Times featured the accounts of laid-off staff members who reviewed the safety of surgical robots, cardiovascular devices and diabetes-care systems that infuse insulin. All had their jobs back as of Monday morning.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 Staffed Up to Review AI and Food Safety. Those Hires Are Now Gone.

Teams evaluating high-tech surgical robots and insulin-delivery systems were gutted by Trump layoffs even though industry fees, not taxpayers, financed the employee salaries.In recent years, the Food and Drug Administration hired experts in surgical robots and pioneers in artificial intelligence. It scooped up food chemists, lab-safety monitors and diabetes specialists who helped make needle pricks and test strips relics of the past.Trying to keep up with breakneck advances in medical technology and the demands of a public troubled by additives like food dyes, the agency enticed scores of midcareer specialists with remote roles and the chance to make a difference in their fields.In one weekend of mass firings across the F.D.A., much of that effort was gone. Most baffling to many were the firings of hundreds whose jobs were not funded by taxpayers. Their positions were financed through congressionally approved agreements that routed fees from the drug, medical device and tobacco industries to the agency.Known as user fees, the money provides adequate staffing for reviews of myriad products. While criticized by some, including the nation’s new health secretary, Robert F. Kennedy Jr., as a corrupting force on the agency, the industry funds are also widely viewed as indispensable: They now account for nearly half of the agency’s $7.2 billion budget.Though the F.D.A. is believed to have lost about 700 of its 18,000 employees, some cuts hit small teams so deeply that staff members believe the safety of some medical devices could be compromised.Among the layoffs were scientists supported by the fees who monitor whether tests pick up ever-evolving pathogens, including those that cause bird flu and Covid. They hobbled teams that evaluate the safety of medical devices like surgical staplers, new systems for diabetes control and A.I. software programs that scan millions of M.R.I.s and other images to detect cancer beyond the human eye. The cuts also eliminated positions for employees who have played a role in assessing the brain-implant technology in Elon Musk’s Neuralink devices.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’s Food Safety Chief Resigns

Jim Jones, the director of the Food and Drug Administration’s food division, resigned on Monday, citing what he called “indiscriminate” layoffs that would make it “fruitless for him to continue.”In his resignation letter, Mr. Jones estimated that 89 people of the 2,000 in his division were fired over the weekend, many of them freshly hired to do more in-depth work on chemical safety to protect the nation’s food supply.“I was looking forward to working to pursue the department’s agenda of improving the health of Americans by reducing diet-related chronic disease and risks from chemicals in food,” Mr. Jones wrote in the letter submitted to Sara Brenner, the acting commissioner of the F.D.A.But the Trump administration’s “disdain for the very people” who would do that work gave him no choice but to depart, he said.Mr. Jones also singled out Robert F. Kennedy Jr., the newly appointed secretary of the Department of Health and Human Services, for criticizing the F.D.A. as being too beholden to the industries it oversees and for vowing to to dismiss the agency’s nutrition staff.“The secretary’s comments impugning the integrity of the food staff, asserting they are corrupt based on falsities, is a disservice to everyone,” Mr. Jones wrote in the letter.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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Kennedy Is Keeping His Stake in Vaccine Litigation

Lawmakers quizzed Robert F. Kennedy Jr. Wednesday during a Senate Finance hearing about his decision to keep a financial stake in litigation against a major vaccine maker.Ethics records released in advance of the hearing said that Mr. Kennedy planned to receive fees on cases with the personal injury law firm Wisner Baum.Mr. Kennedy has referred clients to the firm in cases claiming injuries from the Gardasil vaccine, a Merck product that is meant to prevent cervical cancer that can be caused by the human papillomavirus, or HPV.Mr. Kennedy took the unusual step of keeping his stake in the pending litigation, according to ethics documents he filed in advance of his confirmation hearings. Mr. Kennedy said in his ethics filings that he would end his referral agreement with the law firm but would collect fees related to cases in the continuing cases.The financial arrangement drew sharp criticism from Senator Elizabeth Warren, a Democrat from Massachusetts. She noted Mr. Kennedy’s history of suggesting that drug companies and federal officials are motivated by financial gain.She accused Mr. Kennedy of profiteering from vaccine skepticism. She pointed to the financial stake in litigation against the vaccine maker Merck — and his intention to hold on to it even if he gains regulatory power over the company as health secretary.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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Caroline Kennedy Urges Senators to Reject RFK Jr. for Health Secretary

Caroline Kennedy wrote a letter to key senators on Tuesday, calling her cousin, Robert F. Kennedy Jr., a “predator” who is addicted to the attention he gets from airing dangerous views on vaccinations.She called on lawmakers, who will be questioning Mr. Kennedy at his confirmation hearings to become the nation’s health secretary on Wednesday and Thursday, to reject his nomination. She cited his lack of experience, misinformed views on vaccines and personal attributes. In the letter, she described how he led other families members “down the path of drug addiction.”“His basement, his garage, and his dorm room were the centers of the action where drugs were available, and he enjoyed showing off how he put baby chickens and mice in the blender to feed his hawks,” Ms. Kennedy wrote. “It was often a perverse scene of despair and violence.”Her letter was first reported in The Washington Post.She gave him credit for overcoming his drug addiction, which Mr. Kennedy has discussed extensively, but she said that the collateral damage was extensive.“But siblings and cousins who Bobby encouraged down the path of substance abuse suffered addiction, illness and death while Bobby has gone on to misrepresent, lie and cheat his way through life,” Ms. Kennedy wrote.She criticized his advocacy against vaccines, describing it as part of an addiction to attention and power.“Bobby preys on the desperation of parents of sick children — vaccinating his own children while building a following by hypocritically discouraging other parents from vaccinating theirs,” she wrote.

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RFK Jr. Sought to Stop Covid Vaccinations 6 Months After Rollout

Robert F. Kennedy Jr. petitioned the F.D.A. to revoke authorization of the shots at a time when they were in high demand and considered life-saving.Robert F. Kennedy Jr., President-elect Donald J. Trump’s choice to lead the nation’s health agencies, formally asked the Food and Drug Administration to revoke the authorization of all Covid vaccines during a deadly phase of the pandemic when thousands of Americans were still dying every week.Mr. Kennedy filed a petition with the F.D.A. in May 2021 demanding that officials rescind authorization for the shots and refrain from approving any Covid vaccine in the future.Just six months earlier, Mr. Trump had declared the Covid vaccines a miracle. At the time Mr. Kennedy filed the petition, half of American adults were receiving their shots. Schools were reopening and churches were filling.Estimates had begun to show that the rapid rollout of Covid vaccines had already saved about 140,000 lives in the United States.The petition was filed on behalf of the nonprofit that Mr. Kennedy founded and led, Children’s Health Defense. It claimed that the risks of the vaccines outweighed the benefits and that the vaccines weren’t necessary because good treatments were available, including ivermectin and hydroxychloroquine, which had already been deemed ineffective against the virus.The petition received little notice when it was filed. Mr. Kennedy was then on the fringes of the public health establishment, and the agency denied it within months. Public health experts told about the filing said it was shocking.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 Moves Forward With Last-Minute Push to Cut Nicotine Levels in Cigarettes

In the final days of the Biden administration, the F.D.A. is moving ahead with a proposal to require companies to produce a less addictive product for traditional smokers.The Biden administration unveiled a proposal on Wednesday to cut the level of nicotine in cigarettes, a last-minute push on a plan that could meaningfully cut cancer rates nationwide and extend the lives of millions of cigarette smokers.If finalized, the proposal would require cigarette makers to significantly reduce the levels of nicotine in their products in an effort to make smoking less addictive and less satisfying. Research has suggested that the move would result in fewer people taking up the habit and would help the nation’s roughly 30 million smokers quit or switch to less harmful alternatives like e-cigarettes.The policy is a centerpiece of antismoking initiatives by Dr. Robert Califf, commissioner of the Food and Drug Administration, who has recounted treating cardiology patients ravaged by smoking during his medical career. “It’s the biggest thing I’ve ever seen in terms of societal benefit, cost saving and lives saved, and strokes prevented and cancers prevented,” Dr. Califf said.The policy’s companion effort to ban menthol cigarettes has been set aside indefinitely after vehement opposition from cigarette makers and other opponents, including convenience store retailers.Whether the nicotine reduction plan would survive the incoming administration of President-elect Donald J. Trump is unclear. Mr. Trump has traditionally been industry friendly and opposed to heavily regulating businesses. In addition, he has had the support of tobacco companies, including Reynolds American, which contributed at least $8 million to Mr. Trump’s main super PAC during the presidential campaign. Reynolds has already expressed its opposition to the proposed requirement.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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What Are ‘Healthy’ Foods? New Rules for Labeling Are Issued.

The Food and Drug Administration released final rules on labeling foods as “healthy,” tightening limits for sugar, sodium and saturated fat.The Food and Drug Administration on Thursday updated the definitions of the term “healthy” for labeling on foods, a move that reflected changes in nutrition and that tightened limits on saturated fat, sugar and salt in food that could be sold under that claim.The effort, while seemingly an inconsequential update to a 30-year-old term, set off a veritable food fight of lobbying over which foods made the cut and whether the F.D.A. would violate First Amendment protections in trying to define “healthy.”The F.D.A. said Thursday that its policy, outlined in a final rule, was meant to “empower consumers” by helping them quickly spot nutritious food at the grocery store. The text of the rule said it was part of the agency’s work “to help reduce the burden of diet-related chronic diseases.”“It’s critical for the future of our country that food be a vehicle for wellness,” Dr. Robert Califf, the F.D.A. commissioner, said in a statement. “Improving access to nutrition information is an important public health effort the F.D.A. can undertake to help people build healthy eating patterns.”The 318-page rule sets forth highly specific guidelines around what food manufacturers can label “healthy” or other terms, like “healthful” or “healthiest.” For instance, a 50-gram serving of a dairy product must contain no more than 5 percent of a person’s daily sugar level and 10 percent of a person’s daily salt and saturated fat limit. Similar standards would apply to fruits, grains, vegetables, meat and other foods. The new definition would include some processed and packaged food and several items previously excluded from the definition of “healthy,” like nuts, seeds, salmon, some oils and water.Robert F. Kennedy Jr., who is meeting with lawmakers this week to shore up support for his upcoming confirmation hearings to become secretary of the nation’s top health agency, campaigned for President-elect Donald J. Trump on a message of making the nation healthier through more nutritious food. He criticized the food industry, saying it was poisoning children with artificial additives and ultra-processed foods.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 Tries Last-Ditch Move to Slash Nicotine Levels in Cigarettes

The agency is asking the White House to move ahead with plans to drastically reduce the addictive substance in traditional tobacco cigarettes.In the final days of the Biden administration, the Food and Drug Administration is seeking White House approval to propose a drastic reduction in the amount of nicotine in cigarettes, a longstanding goal of public health experts that has faced stiff opposition from the powerful tobacco lobby.The F.D.A. submitted the proposal to the Office of Management and Budget only on Tuesday, a sign that the move was perhaps more wishful and symbolic than realistic for a White House juggling many late-term agenda items. And traditionally, the budget office’s review of agency proposals can take months.“I think it’s a milestone in progress toward the single most game-changing tobacco regulatory policy, in terms of lives that could be saved, that F.D.A. could ever do,” said Mitch Zeller, a former director of the agency’s tobacco center. “Having said that, it’s only a proposed rule, and we’re obviously in the waning days and weeks of an outgoing administration.”Even if the F.D.A. receives clearance from the White House to advance the proposal, whether it can survive once President-elect Donald Trump takes office in January is unclear given the sustained opposition from the industry. The tobacco lobby was also a significant donor to Mr. Trump’s campaign; the cigarette maker Reynolds American had given $8.5 million to his main super PAC by late October.Mr. Trump is known to personally oppose cigarette smoking, but has not weighed in recently on agency issues like nicotine levels in cigarettes. He has chosen Robert F. Kennedy Jr. as his likely nominee to run the nation’s top health agency, and Mr. Kennedy has railed against federal subsidies given to tobacco growers, saying they eclipse those sent to other farmers who grow fruits and vegetables. He listed the problem as evidence that “we are just poisoning” people and contributing to chronic disease.“It makes no sense if we want a healthy country,” he said in a speech in August.A World Health Organization study estimated in 2023 that the U.S. Agriculture Department allocated $437 million in subsidies to tobacco farmers from 2015 through 2020.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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Dr Martin Makary Chosen to Head the FDA

President-elect Donald J. Trump announced on Friday that he would nominate Dr. Martin A. Makary, a Johns Hopkins University surgeon with a contrarian streak, to be commissioner of the Food and Drug Administration.In a post on social media, Mr. Trump said: “F.D.A. has lost the trust of Americans and lost sight of its primary goal as a regulator.” He said that Dr. Makary would work under Robert F. Kennedy Jr., the president-elect’s choice for the cabinet-level role as health secretary, to “properly evaluate harmful chemicals poisoning our nation’s food supply and drugs.”“I am confident that Dr. Makary, having dedicated his career to high-quality, lower-cost care will restore the F.D.A. to the gold standard of scientific research and cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Mr. Trump said in a statement.Dr. Makary, 54, rose to prominence more than a decade ago as a critic of the medical establishment, speaking out about patient safety and working with hospitals to improve practices. He also gained attention during the pandemic, weighing in on herd immunity, vaccines and masks in 2021, roiling some doctors who were still contending with packed I.C.U.s and hundreds of deaths a week.As F.D.A. commissioner, Dr. Makary would lead an agency that has come under considerable fire from Mr. Kennedy Jr., who would be his boss if confirmed by the Senate to become secretary of the Department of Health and Human Services.Mr. Kennedy has been outspoken in his desire to overhaul the F.D.A., saying he would fire agency staff members whom he argued had “suppressed” disputed and sometimes harmful treatments; would gut an entire department; and would clamp down on the food and pharmaceutical industries. Mr. Kennedy has also criticized the so-called user fees from drug and medical device companies that pay for thousands of employees to review industry products and account for nearly half of the agency’s overall budget of $7.2 billion.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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