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    F.D.A. Looks to A.I. to Enhance Efficiency

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    With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed drugs to the market.The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.“The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.“I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”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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      What to Know About the Effects of Ketamine

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      Elon Musk has said that he used ketamine as a treatment in the past, but he denied reports that he was taking it frequently and recreationally.News reports detailing Elon Musk’s drug use have prompted renewed attention to ketamine, a powerful anesthetic that has become increasingly popular as a therapy for treatment-resistant depression and other mental health issues.Although Mr. Musk has acknowledged using ketamine in the past to treat depression, he has denied suggestions that he is currently using ketamine — or any other drug.“I am NOT taking drugs!” he wrote last week in a social media post following the publication of an article in The New York Times that described reports of his use of drugs on the campaign trail last year. Those drugs included ketamine and other psychedelic compounds, among them MDMA and psilocybin mushrooms.Mr. Musk left the White House last week. Since then, he and President Trump have traded barbs on social media over the president’s domestic policy bill and have mentioned government contracts with Mr. Musk’s companies and Mr. Musk’s relationship to the White House.Mr. Trump, who was briefed on the article in The Times, has been telling associates in the last day or so that Musk’s “crazy” behavior is linked to his drug use, according to a Times report citing two people with knowledge of Mr. Trump’s private conversations. But later on Friday, Mr. Trump told reporters he did not want to comment on Mr. Musk’s drug use.The very public feud between the two men has once again drawn unflattering attention to ketamine, a drug that has become increasingly available at legal clinics across the country. It is also used recreationally and can be dangerous when misused.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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      Four States Ask F.D.A. to Lift Special Restrictions on Abortion Pill

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      The states consider it a move to force the F.D.A. to review and acknowledge extensive research showing the pill’s safety.In a strategy aimed at countering efforts to further restrict the abortion pill mifepristone, attorneys general of four states that support abortion rights on Thursday asked the Food and Drug Administration to do the opposite and lift the most stringent remaining restrictions on the pill.The petition filed by Massachusetts, New York, California and New Jersey might seem surprising given the opposition to abortion expressed by Trump administration officials. But the attorneys general consider it a move that would require the F.D.A. to acknowledge extensive scientific research that has consistently found mifepristone safe and effective, said an official with the Massachusetts attorney general’s office who worked on the filing and asked not to be named in order to share background information. It would also prevent the F.D.A. from changing mifepristone regulations while the petition is pending.The petition notes that at a May senate hearing, Robert F. Kennedy Jr., the health and human services secretary, responded to questions by Senator Josh Hawley, Republican of Missouri, who opposes abortion, by saying he had ordered the F.D.A. to do a “complete review” of mifepristone.“We want to make sure that when F.D.A. is making these decisions that they have all the data in front of them, all of the really powerful data that show that mifepristone is safe” the Massachusetts official said.The F.D.A. is required to respond within 180 days by granting or denying the request, or saying it needs more time. In its responses, the agency must document its position, which could be useful in lawsuits, including one that the four states could file if their petition is denied.Mifepristone, which blocks a hormone necessary for pregnancy development, was approved for abortion in America in 2000. The F.D.A. imposed an additional regulatory framework called Risk Evaluation and Mitigation Strategy, or REMS, on mifepristone. That framework has been used for only about 300 drugs, currently covering only about 60 medications.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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      A Blood Test for Alzheimer’s: What to Know

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      The test may make it easier to identify whether people with memory and thinking problems have Alzheimer’s or not.A blood test that can help diagnose Alzheimer’s disease has received clearance from the Food and Drug Administration. This is a step toward a goal of scientists and doctors to one day be able to diagnose a confounding illness with the prick of a finger. But there is still a long way to go.Here is what to know:What is the test, and how should it be used?The test, manufactured by Fujirebio Diagnostics, is intended to be used only by specialists in Alzheimer’s, the F.D.A. said. Its mouthful of a name — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio — describes what the test measures: levels of two proteins, amyloid and tau, that are hallmarks of Alzheimer’s disease.In people who develop Alzheimer’s, amyloid begins to accumulate and form plaques in the brain more than 20 years before any symptoms of cognitive impairment. Tau accumulates later, forming tangles in the brain, and is much more closely correlated with cognitive decline.Can people who don’t have memory problems take the blood test?No. The F.D.A., and Alzheimer’s experts, emphasized that the blood test should be given only to people who are already experiencing cognitive decline and are ages 55 and older. Moreover, it should not be used on its own to diagnose or to rule out Alzheimer’s.“Other clinical evaluations or additional tests should be used for determining treatment options,” the F.D.A. said in a statement, adding that “the results must be interpreted in conjunction with other patient clinical information.”The current gold standard for diagnosing Alzheimer’s still involves either imaging using PET scans, which are expensive, or spinal taps, which are invasive. The blood test can help flag the presence of the Alzheimer’s-related proteins, and doctors might then order confirmatory testing with one of the other methods.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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      F.D.A. Approves Novavax Covid Vaccine With Stricter New Conditions

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      The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others over age 12 who have at least one medical condition that puts them at high risk from Covid.Scientific advisers to the Centers for Disease Control and Prevention, who typically make decisions on who should get approved shots and when, have been debating whether to recommend Covid shots only to the most vulnerable Americans. The F.D.A.’s decision appeared to render at least part of their discussion moot.The new restriction will sharply limit access to the Novavax vaccine for people under 65 who are in good health. It may leave Americans who do not have underlying conditions at risk if a more virulent version of the coronavirus were to emerge. It could also limit options for people who want the vaccine for a wide array of reasons, including to protect a vulnerable loved one.The vaccine had previously been authorized under emergency use. Covid vaccines developed by Pfizer-BioNTech and Moderna, which are more widely used by Americans, were granted full approval in 2022. However, the companies are working on updated shots for the fall, and the new restrictions on the Novavax shot portend a more restrictive approach from the F.D.A.The F.D.A.’s new restrictions also appeared to reflect the high degree of skepticism about vaccines from Robert F. Kennedy Jr., the health secretary, and the other leaders he has appointed at health agencies.“This is incredibly disappointing,” said Dr. Camille Kotton, an infectious disease physician at Massachusetts General Hospital who cares for immunocompromised patients, and a former adviser to the C.D.C.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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      Trump Budget Cuts Hobble Antismoking Programs

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      Students at Wyoming East High School in West Virginia’s coal country had different reasons for joining Raze, a state program meant to raise awareness about the health risks of tobacco and e-cigarettes.Cayden Oliver, 17, grew up around generations of people who smoked and vaped, and he wanted to make his own choice. Nathiah Brown, 18, was struggling to quit e-cigarettes and showed up for moral support. Kimberly Mills, 18, wanted to prove that even though she had been a foster child, she would defy the odds.This high school’s program cost West Virginia less than $3,000 a year and was meant to protect teenagers in the state that has the highest vaping rate in their age group. It fell prey to U.S. government health budget cuts that included hundreds of millions of dollars in tobacco control funds that reached far beyond Washington, D.C.At the high school, students pack into stalls in the school restrooms, sneaking puffs between classes. “It’s bad now,” said Logan Stacy, 18, a member of the Raze group. “Imagine what it will be like in two years.”Experts on tobacco control said the Trump administration’s funding cuts would set back a quarter-century of public health efforts that have driven the smoking rate to a record low and saved lives and billions of dollars in health care spending. Still, the Centers for Disease Control and Prevention estimates that nearly 29 million people in the United States continue to smoke.The decimation of antismoking work follows a year of lavish campaign donations by tobacco and e-cigarette companies to President Trump and congressional Republicans.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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      5 Places to Turn for Accurate Health Information

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      Changes to federal health websites have raised concerns about their reliability. These independent sources offer an alternative.Soon after President Donald J. Trump took office for his second term, thousands of health websites run by the federal government that kept the public informed about infectious diseases, mental health, vaccines and more were taken offline.Many eventually returned — in large part because a judge ordered the Centers for Disease Control and Prevention to temporarily restore the pages — but some had been altered, with sections on topics such as health equity and teen pregnancy deleted. The changes, along with uncertainty around the future of these sites, has led some public health experts to question whether the websites can still be trusted as the gold standard of trustworthy health information, as they’ve long been regarded.Federal health agencies are already facing a crisis of confidence. When a recent national poll asked respondents how much trust they had in the C.D.C. to make the right health recommendations, more than one-third replied “not much” or “not at all.” Nearly half said the same about the Food and Drug Administration.Experts fear that with less trust in public health institutions, more people seeking medical information might turn to social media, where misinformation is rampant. That has made it all the more valuable for the public to find evidenced-based sources of health information.Here are five websites run by independent organizations that have accurate, easy-to-understand information.1. Vaccine Education CenterOf all the health information on federal websites, medical experts have been increasingly concerned about the availability of accurate vaccine information. Robert F. Kennedy Jr., the nation’s health secretary, has been a longtime critic of vaccines and has spread misinformation about their safety for years.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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      RFK Jr. Announces Ban on Food Dyes and Says ‘Sugar Is Poison’

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      Health Secretary Robert F. Kennedy Jr. escalated his war against the food industry on Tuesday, declaring that “sugar is poison.”Mr. Kennedy’s comment came during a highly publicized news conference where he also asserted that he has “an understanding” with major food manufacturers to remove petroleum-based food colorings from their products by 2026.No one from the food industry attended the event, and none have publicly agreed to Mr. Kennedy’s demands, although the International Dairy Foods Association has pledged to eliminate artificial colors in milk cheese and yogurt sold to schools as part of the federal lunch and breakfast programs by the start of the 2026 school year.However, Mr. Kennedy and his advisers said that every major food manufacturer and some fast-food companies have contacted the agency looking for guidance.“Four years from now, we are going to have most of these products off the market, or you will know about them when you go to the grocery store,” Mr. Kennedy said.Mr. Kennedy’s push to get food manufacturers to remove dyes from their products is his first effort at sweeping reform of the food industry, which he has long blamed for creating and marketing ultra-processed foods that he says are making Americans obese and contributing to a host of diseases, including diabetes and heart disease.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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      Patients Cut Off From Cheaper Obesity Drugs as FDA Halts Sales of Copycats

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      Hundreds of thousands of Americans stand to soon lose their access to cheaper weight-loss drugs, with a federal crackdown on copycat versions threatening to disrupt treatment and raise costs.The Food and Drug Administration has ordered producers and sellers of the less expensive products to wind down operations in the coming weeks now that it has declared there are no longer shortages of the blockbuster drugs Wegovy and Zepbound.Produced through a process of mixing drug ingredients known as compounding, the copycat medications had spawned a booming multi-billion-dollar industry. Patients turned to compounding because their health insurance would not pay for the brand-name drugs and they could buy the compounded versions for less than $200 a month in some cases.Eli Lilly and Novo Nordisk now offer the brand-name drugs for $500 a month in most cases to patients who pay with their own money instead of going through insurance. Until recently, patients sometimes had to pay over $1,300 a month.The F.D.A. ordered compounding for versions of Eli Lilly’s Zepbound to end last month. Small compounders have until April 22 to stop making and selling versions of Novo Nordisk’s Wegovy; large compounders have until May 22.It is not clear how the F.D.A. will enforce these deadlines. The Health and Human Services Department, which oversees the F.D.A., declined to answer questions for this article.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