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      Dr Martin Makary Chosen to Head the FDA

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      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.Mr. Trump announced two other top health picks on Friday evening as well. He chose Dr. Dave Weldon, a physician and former congressman from Florida, to lead the Centers for Disease Control and Prevention.For years, Dr. Weldon championed the notion that thimerosal, a preservative once used widely in vaccines, caused an explosion of autism cases around the world. In 2007, he backed a bill proposing to take vaccine safety research out of the hands of the C.D.C. Health officials reject the idea that research shows any link between thimerosal and autism.Mr. Trump also put forward Dr. Janette Nesheiwat, a physician and Fox News contributor, to be surgeon general. She worked caring for patients after Hurricane Katrina, an announcement from Mr. Trump said, and on the front lines of the Covid pandemic in New York City. She also markets vitamin B and vitamin C dietary supplements.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

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      Kennedy’s Views Mix Mistrust of Business With Bizarre Health Claims

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      Seven years after Americans celebrated the licensing of Jonas Salk’s polio vaccine, President John F. Kennedy called on Congress to finance a nationwide vaccination program to stamp out what he called the “ancient enemies of our children”: infectious disease.Now Kennedy’s nephew, Robert F. Kennedy Jr., is the nation’s chief critic of vaccines — a public health intervention that has saved millions of lives — and President-elect Donald J. Trump’s pick to become the next secretary of health and human services. Mr. Kennedy calls himself a vaccine safety activist. The press calls him a vaccine skeptic. His detractors call him an anti-vaxxer and a conspiracy theorist.Whatever one calls him, Mr. Kennedy is a polarizing choice whose views on certain public health matters beyond vaccination are far outside the mainstream. He opposes fluoride in water. He favors raw milk, which the Food and Drug Administration deems risky. And he has promoted unproven therapies like hydroxychloroquine for Covid-19. His own relatives called his presidential bid “dangerous for our country.”If there is a through line to Mr. Kennedy’s thinking, it appears to be a deep mistrust of corporate influence on health and medicine. In some cases, that has led him to support positions that are also embraced by public health professionals, including his push to get ultra-processed foods, which have been linked to obesity, off grocery store shelves. His disdain for profit-seeking pharmaceutical manufacturers and food companies drew applause on the campaign trail.People close to him say his commitment to “make America healthy again” is heartfelt.“This is his life’s mission,” said Brian Festa, a founder of We the Patriots U.S.A., a “medical freedom” group that has pushed back on vaccine mandates, who said he has known Mr. Kennedy for years.But like Mr. Trump, Mr. Kennedy also has a tendency to float wild theories based on scanty evidence. And he has hinted at taking actions, like prosecuting leading medical journals, that have unnerved the medical community. On Friday, many leading public health experts reacted to his nomination with alarm.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

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      Robert F. Kennedy Jr.’s FDA Wish List: Raw Milk, Stem Cells, Heavy Metals

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      Robert F. Kennedy Jr., one of President-elect Donald J. Trump’s advisers on health, is taking aim at the agency’s oversight on many fronts.Robert F. Kennedy Jr. has been unflinching in his attacks on the Food and Drug Administration in recent weeks, saying he wants to fire agency experts who have taken action against treatments that have sometimes harmed people or that teeter on the fringe of accepted health care practice.How much influence Mr. Kennedy will have in President-elect Donald J. Trump’s next administration remains unclear, with some suggesting that he could act as a White House czar for policy over several federal health agencies. Mr. Trump has voiced support for Mr. Kennedy in recent weeks, saying he will let him “go wild on health.” In his acceptance speech, Mr. Trump reiterated his support for Mr. Kennedy’s involvement on health matters.Some of Mr. Kennedy’s priorities are relatively standard, such as focusing on the health effects associated with ultraprocessed foods. Yet others threaten to undermine F.D.A. authority to rein in inappropriate medical treatments or to warn about products that can damage the public health.A spokeswoman for Mr. Kennedy did not respond to interview requests.Days before the election, in a post on X that has received 6.4 million views, Mr. Kennedy threatened to fire F.D.A. employees who have waged a “war on public health.” He listed some of the products that he claimed the F.D.A. had subjected to “aggressive suppression,” including ivermectin, raw milk, vitamins as well as therapies involving stem cells, and hyperbaric oxygen.Some items that he singled out had become flash points for conservative voters during the coronavirus pandemic, including ivermectin, which was found to be an ineffective treatment against Covid.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

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      From AI to Musk’s Brain Chip, the F.D.A.’s Device Unit Faces Rapid Change

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      The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary technology.There are now artificial intelligence programs that scan M.R.I.s for signs of cancer, Apple AirPods that work as hearing aids and devices that decode the electrical blips of the brain to restore speech to those who have lost it.Medical device technology is now deeply entrenched in many patients’ health care and can have a stunning impact on their lives. As advancements become more tangible to millions of Americans, regulation of the devices has commanded increasing attention at the Food and Drug Administration.Dr. Michelle Tarver, a 15-year-veteran of the agency, is stepping into that spotlight at a critical time. She is taking the reins of the F.D.A.’s device division from Dr. Jeffrey Shuren, who forged deep ties with the device industry, sped up the pace of approvals and made the agency more approachable to companies. Some of those device makers were represented by Dr. Shuren’s wife and her law firm, posing ethical conflicts for him that continue to draw scrutiny.Dr. Michelle Tarver, an ophthalmologist and a 15-year veteran of the F.D.A.’s medical device division.U.S. Food and Drug AdministrationMore broadly, congressional lawmakers and consumer advocates have become increasingly concerned about the device industry’s influence over the sprawling division, which has a budget of about $790 million and a staff of 2,500. Device safety and standards for agency approvals of products as intimate as heart valves or neural implants will be at the forefront of the division’s mission in the coming years. Among the issues Dr. Tarver will encounter:Brains, computers and Elon MuskFew devices will require such intense oversight as one of the most breathtaking technologies in development: brain-computer interfaces that dip into the surface layers of the brain to decode its electrical noise — and return function to people who have lost it.Researchers from a number of teams have demonstrated the capability to restore the voice and speech of a California man with ALS, to enable a paralyzed man to walk and to help a man who is paralyzed below the neck to play Mario Kart by simply thinking about steering left or right.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

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      Salmonella Outbreak Prompts Egg Recall by Wisconsin Farm

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      Officials said 65 people in nine states have been infected in the outbreak, which has been traced to an egg farm. No deaths have been reported.A salmonella outbreak that has sickened dozens of people in nine states prompted a recall of certain brands of eggs on Friday after officials said they traced the source of the infections to a farm in Wisconsin.State health officials said that 42 of the 65 people infected were in Wisconsin. Many people reported eating eggs at restaurants in the state before they got sick.Officials were able to trace the source of the eggs to Milo’s Poultry Farms of Bonduel, Wis., where they identified the outbreak strain in a packing facility and a hens egg-laying house, the U.S. Centers for Disease Control and Prevention said.All carton sizes and egg types produced at the farm, which either bear the label “Milo’s Poultry Farms” or “Tony’s Fresh Market,” were recalled by the farm, the U.S. Food and Drug Administration said.The eggs were distributed to retail stores and food service suppliers in Illinois, Michigan and Wisconsin, the F.D.A. said. The recall includes all expiration dates. The exact number of eggs recalled was not immediately available.No deaths have been reported in the outbreak, but 24 people were hospitalized. The first case was reported in late May, but most infections were reported in July and August, according to the C.D.C.The reported number of people infected is likely an undercount because it usually takes weeks to determine if an infection is part of an outbreak and because some people may recover without testing for the bacteria, the C.D.C. said.Aside from Wisconsin, infections were reported in California, Colorado, Illinois, Iowa, Michigan, Minnesota, Utah and Virginia. Illinois reported the second-highest number of infections with 11, followed by Minnesota, which reported three.The symptoms of the bacterial infection include diarrhea, fever and abdominal pain and usually begin within three days of ingesting the contaminated food, the F.D.A. said.Symptoms usually clear up within a week, but people with weakened immune systems, including young children and older adults, are more susceptible to severe, and sometimes fatal, infections, the F.D.A. said.The egg recall came after a deadly summer outbreak of listeria that prompted the recall of seven million pounds of Boar’s Head deli meat products.That outbreak has resulted in nine deaths and dozens of hospitalizations and the temporary shutdown of a Boar’s Head plant in Virginia, where inspectors had found black mold, water dripping over meat and dead flies. More

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      FDA Declines to Approve MDMA Therapy, and Seeks Further Study

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      The agency said there was insufficient data to allow the use of a treatment for PTSD that involves the drug known as Ecstasy.The Food and Drug Administration on Friday declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder, dealing a serious blow to the nascent field of psychedelic medicine and dashing the hopes of many Americans who are desperate for new treatments.The F.D.A. said there was insufficient data to allow its use, and it asked the company seeking approval for the treatment, Lykos Therapeutics, to conduct an additional clinical trial to assess whether the drug, commonly known as Ecstasy or molly, would be safe and effective.An additional clinical trial could add years, and millions of dollars, to the approval process.If approved, MDMA would have become the first psychedelic compound to be regulated by federal health authorities. Supporters of psychedelic medicine were deeply disappointed, and some said they were stunned, having assumed the therapy’s promising data would overcome flaws in the company’s clinical trials, which had been designed in consultation with F.D.A. scientists.“This is an earthquake for those in the field who thought F.D.A. approval would be a cinch,” said Michael Pollan, the best-selling author and co-founder of the UC Berkeley Center for the Science of Psychedelics. His book, “How to Change Your Mind,” helped catalyze public interest in the therapeutic potential of psychoactive compounds, demonized during the nation’s long war on drugs.But the agency’s decision had not been entirely unexpected, after a group of independent experts convened by the F.D.A. to evaluate Lykos’s data met in June and did not recommend the treatment. On two central questions, the experts voted overwhelmingly that the company had not proven the treatment was effective, and that the drug therapy’s benefits did not outweigh the risks.The agency generally follows the recommendations of its outside panels. Critics, however, have questioned the panel’s expertise, noting that only one of its 11 members had experience in psychedelic medicine.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

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      FDA Panel Weights MDMA Therapy for PTSD

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      An independent group of experts is meeting Tuesday to consider whether to allow use of this illegal drug, also known as Ecstasy, to treat PTSD. The Food and Drug Administration is weighing whether to approve the use of MDMA, also known as Ecstasy, for treatment of post-traumatic stress disorder. An independent advisory panel of experts will review studies on Tuesday and is expected to vote on whether the treatment would be effective and whether its benefits outweigh the risks.The panel will hear from Lykos Therapeutics, which has submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of MDMA and talk therapy.Millions of Americans suffer from PTSD, including military veterans who are at high risk of suicide. No new treatment for PTSD has been approved in more than 20 years.What is MDMA?Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being resynthesized in the mid-1970s by Alexander Shulgin, a psychedelic chemist in the Bay Area, MDMA gained popularity among therapists. Early research suggested significant therapeutic potential for a number of mental health conditions.MDMA is an entactogen, or empathogen, that fosters self-awareness, feelings of empathy and social connectedness. It is not a classic psychedelic like LSD or psilocybin, drugs that can cause altered realities and hallucinations. Among recreational users, MDMA is commonly known as molly or Ecstasy.In 1985, as the drug became a staple at dance clubs and raves, the Drug Enforcement Administration classified MDMA as a Schedule I substance, a drug defined as having no accepted medical use and a high potential for abuse.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

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      One in Five Milk Samples Nationwide Shows Genetic Traces of Bird Flu

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      There is no evidence that the milk is unsafe to drink, scientists say. But the survey result strongly hints that the outbreak may be widespread.Federal regulators have discovered fragments of bird flu virus in roughly 20 percent of retail milk samples tested in a nationally representative study, the Food and Drug Administration said in an online update on Thursday.Samples from parts of the country that are known to have dairy herds infected with the virus were more likely to test positive, the agency said. Regulators said that there is no evidence that this milk poses a danger to consumers or that live virus is present in the milk on store shelves, an assessment public health experts have agreed with.But finding traces of the virus in such a high share of samples from around the country is the strongest signal yet that the bird flu outbreak in dairy cows is more extensive than the official tally of 33 infected herds across eight states.“It suggests that there is a whole lot of this virus out there,” said Richard Webby, a virologist and influenza expert at St. Jude Children’s Research Hospital.Dr. Webby said that he believed it was still possible to eradicate the virus, which is known as H5N1, from the nation’s dairy farms. But it will be difficult to design effective control measures without knowing the scope of the outbreak, he said.The findings also raise questions about how the virus has evaded detection and where else it might be silently spreading. Some scientists have criticized the federal testing strategy as too limited to reveal the true extent of viral spread.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