Food and Drug Administration

Subterms

    More stories

    • 125 Shares159 Views

      in Elections

      Top FDA Vaccine Official Resigns, Citing Kennedy’s ‘Misinformation and Lies’

      by

      The Food and Drug Administration’s top vaccine official, Dr. Peter Marks, resigned under pressure Friday and said that Health Secretary Robert F. Kennedy Jr.’s aggressive stance on vaccines was irresponsible and posed a danger to the public.“It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Dr. Marks wrote to Sara Brenner, the agency’s acting commissioner. He reiterated the sentiments in an interview, saying: “This man doesn’t care about the truth. He cares about what is making him followers.”Dr. Marks resigned after he was summoned to the Department of Health and Human Services Friday afternoon and told that he could either quit or be fired, according to a person familiar with the matter.Dr. Marks led the agency’s Center for Biologics Evaluation and Research, which authorized and monitored the safety of vaccines and a wide array of other treatments, including cell and gene therapies. He was viewed as a steady hand by many during the Covid pandemic but had come under criticism for being overly generous to companies that sought approvals for therapies with mixed evidence of a benefit.His continued oversight of the F.D.A.’s vaccine program clearly put him at odds with the new health secretary. Since Mr. Kennedy was sworn in on Feb. 13, he has issued a series of directives on vaccine policy that have signaled his willingness to unravel decades of vaccine safety policies. He has rattled people who fear he will use his powerful government authority to further his decades-long campaign of claiming that vaccines are singularly harmful, despite vast evidence of their role in saving millions of lives worldwide.“Undermining confidence in well-established vaccines that have met the high standards for quality, safety and effectiveness that have been in place for decades at F.D.A. is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety and security,” Dr. Marks wrote.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. More

    • 125 Shares139 Views

      in Elections

      West Virginia Bans 7 Artificial Food Dyes, Citing Health Concerns

      by

      At least 20 other states are considering bills restricting the use of certain food dyes and additives.In the most sweeping move of its kind, West Virginia has banned foods containing most artificial food dyes and two preservatives, citing their potential health risks.The legislation, signed into law Monday by Gov. Patrick Morrisey, will go into effect in 2028. At least 20 states are considering similar restrictions on food chemicals, but West Virginia is the first to ban virtually all artificial dyes from foods sold statewide. The new law will also prohibit products containing the dyes from being served in school meals starting this August.“Everybody realizes that we’ve got to do something about food in general,” said Adam Burkhammer, a Republican state representative who introduced the bill in February. It quickly passed both legislative houses with broad bipartisan support. Mr. Burkhammer said he hopes the law will improve the health of children in his state and spur other states to take similar actions.California has passed similar measures, though they were narrower in scope. One, passed in 2023, banned four food additives statewide. And in 2024, state lawmakers banned artificial food dyes from school meals.Jennifer Pomeranz, an associate professor of public health policy and management at New York University, said the California measures likely led state lawmakers to realize they could move faster than the Food and Drug Administration to act on food additives that carried health concerns.She added that Robert F. Kennedy Jr., who was confirmed as health secretary last month and has spoken frequently of his concerns about food dyes, has also brought more attention to the issue. Earlier this month, at a meeting with executives from large food companies including PepsiCo and General Mills, Mr. Kennedy said that it was an “urgent priority” to eliminate artificial dyes from foods and drinks sold nationwide. At another meeting, he encouraged people to call Gov. Morrissey in support of the West Virginia law.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. More

    • 125 Shares169 Views

      in Elections

      Trump Administration Delays Requirement for Companies to Track Tainted Food

      by

      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. More

    • 125 Shares189 Views

      in Elections

      Food Safety Jeopardized by Onslaught of Funding and Staff Cuts

      by

      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. More

    • 125 Shares189 Views

      in Elections

      F.D.A. Expands Access to Clozapine, a Key Treatment for Schizophrenia

      by

      Federal regulators will no longer require patients to provide blood tests before receiving the drug from pharmacies.The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses.The agency announced on Monday that it was eliminating a requirement that patients submit blood tests before their prescriptions can be filled.Clozapine, which was approved in 1989, is regarded by many physicians as the most effective available treatment for schizophrenia, and research shows that the drug significantly reduces suicidal behavior. Clozapine is also associated with a rare side effect called neutropenia, a drop in white blood cell counts that, in its most severe form, can be life-threatening.In 2015, federal regulators imposed a regimen known as risk evaluation and mitigation strategies, or REMS, that required patients to submit to weekly, biweekly and monthly blood tests that had to be uploaded onto a database and verified by pharmacists.Physicians have long complained that, as a result, clozapine is grossly underutilized.Dr. Frederick C. Nucifora, director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, said he believed that around 30 percent of patients with schizophrenia would benefit from clozapine — far more than the 4 percent who currently take it.“I have had many patients who were doing terribly, who struggled to function outside the hospital, and cycled through many medications,” he said. “If they go on clozapine, they really tend to not be hospitalized again. I’ve had people go on to finish college and work. It’s quite remarkable.”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. More

    • 125 Shares119 Views

      in Elections

      Cucumbers Are Recalled After Salmonella Sickens People in 19 States

      by

      At least 68 people have fallen ill in the outbreak believed to be linked to cucumbers sold in the United States and Canada, the Centers for Disease Control and Prevention said.At least 68 people, including 18 that needed to be treated at hospitals, have fallen ill across 19 states in a salmonella outbreak that may be linked to cucumbers, the Centers for Disease Control and Prevention said on Friday.Federal officials announced they were investigating the outbreak believed to be tied to cucumbers grown by Agrotato, S.A. de C.V. in Sonora, Mexico, and sold by SunFed Produce, which is based in Arizona, and other importers. No deaths have been reported.The C.D.C. said it was working with public health and regulatory officials in several states, including the Food and Drug Administration, to investigate the infections.The cucumbers were sold in the United States and Canada, according to the F.D.A.SunFed recalled all sizes of the product described as “whole fresh American cucumbers.”Craig Slate, the president of SunFed, said in a statement that the company “immediately acted to protect consumers.”“We are working closely with authorities and the implicated ranch to determine the possible cause,” he said.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. More

    • 113 Shares189 Views

      in Elections

      How Will Trump’s Covid Contrarians Handle the Next Pandemic?

      by

      President-elect Donald J. Trump had already succeeded in rattling the nation’s public health and biomedical establishment by the time he announced on Tuesday that he had picked Dr. Jay Bhattacharya to run the National Institutes of Health. But amid growing fears of a deadly bird flu pandemic, perhaps no one was more rattled than experts in infectious disease.Dr. Bhattacharya, a Stanford University medical economist and outspoken opponent of lockdowns, masking, school closures and other Covid-19 mitigation measures, and Mr. Trump’s other health picks have one thing in common. They are all considered Covid contrarians whose views raise questions about how they would handle an infectious disease crisis.Robert F. Kennedy Jr., Mr. Trump’s choice for health secretary, has said he wants the N.I.H. to focus on chronic disease and “give infectious disease a break for about eight years.” Dr. Martin Makary, the president-elect’s choice to run the Food and Drug Administration, incorrectly predicted in 2021 that the nation was “racing toward an extremely low level of infection.”Dr. David Weldon, a Republican former congressman who is Mr. Trump’s choice to lead the Centers for Disease Control and Prevention, has espoused the debunked theory that thimerosal, a mercury compound in certain vaccines, causes autism. As a congressman, he introduced legislation that would strip the C.D.C. of its role in ensuring vaccine safety, saying the agency had a “conflict of interest” because it also promotes vaccination.And Dr. Mehmet Oz, the talk show host who has been picked by Mr. Trump to run Medicare and Medicaid, prodded officials in the first Trump administration to give emergency authorization for the malaria drug hydroxychloroquine to treat Covid-19. The F.D.A. later revoked the authorization when studies showed the drug carried risks, including serious heart issues, to coronavirus patients.Robert F. Kennedy Jr. has said he wants to focus on chronic diseases rather than infectious diseases as head of the Department of Health and Human Services. Haiyun Jiang for The New York TimesWe 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. More

    • 125 Shares179 Views

      in Elections

      Trump’s Choices for Health Agencies Suggest a Shake-Up Is Coming

      by

      The picks to oversee public health have all pushed back against Covid policies or supported ideas that are outside the medical mainstream.A longtime leader of the anti-vaccine movement. A highly credentialed surgeon. A seven-term Florida congressman. A Fox News contributor with her own line of vitamins.President-elect Donald J. Trump’s eclectic roster of figures to lead federal health agencies is almost complete — and with it, his vision for a sweeping overhaul is coming into focus.Mr. Trump’s choices have varying backgrounds and public health views. But they have all pushed back against Covid policies or supported ideas that are outside the medical mainstream, including an opposition to vaccines. Together, they are a clear repudiation of business as usual.“What they’re saying when they make these appointments is that we don’t trust the people who are there,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the Food and Drug Administration.Some doctors and scientists are bracing themselves for the gutting of public health agencies, a loss of scientific expertise and the injection of politics into realms once reserved for academics. The result, they fear, could be worse health outcomes, more preventable deaths and a reduced ability to respond to looming health threats, like the next pandemic. “I’m very, very worried about the way that this all plays out,” Dr. Offit said.But other experts who expressed concerns about anti-vaccine views at the helms of the nation’s health agencies said that some elements of the picks’ unorthodox approaches were welcomed. After a pandemic that closed schools across the country and killed more than one million Americans, many people have lost faith in science and medicine, surveys show. And even some prominent public health experts were critical of the agencies’ Covid missteps and muddled messaging on masks and testing.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. More