logo
FDA taps biotech industry veteran as RFK Jr.'s top drug regulator

FDA taps biotech industry veteran as RFK Jr.'s top drug regulator

CNBC3 days ago
The Food and Drug Administration said on Monday it has appointed former biotech executive George Tidmarsh as the agency's top drug regulator.
Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University's School of Medicine, Fpauswill lead one of the biggest and most crucial divisions of the FDA, which reviews the vast majority of new drug applications.
The Center for Drug Evaluation and Research, or CDER, regulates over-the-counter and prescription treatments, including biologic therapies and generics. The acting head of CDER, Jacqueline Corrigan-Curay, announced in June she was retiring.
Tidmarsh will step in as the FDA and its regulatory process face massive upheaval under Health and Human Services Secretary Robert F. Kennedy Jr. Kennedy has pursued deep staff cuts across HHS and, in some cases, brought in new employees who either lack relevant scientific and medical experience or share his skepticism of vaccines.
But Tidmarsh's extensive background in the industry and involvement in the development of seven now-approved drugs is likely a sigh of relief for the pharmaceutical industry. His previous comments signal that he could take a more hardline approach to regulating drugs.
In an opinion piece in April, Tidmarsh slammed regulatory decisions made by a key official pushed out of the FDA under Kennedy, Peter Marks. That includes supporting the accelerated approval of Biogen's ill-fated Alzheimer's drug, Aduhelm, and overruling FDA staff to expand approval of Sarepta Therapeutics' Duchenne muscular dystrophy treatment Elevidys.
Last week, the FDA asked Sarepta Therapeutics to halt all shipments of Ele­vidys after three patients died from liver failure after taking it or a similar treatment. The company later said it would not stop shipments to treat patients with the condition who can still walk, saying data show "no new or changed safety signals" within that group.
Tidmarsh will likely have a say on that controversial accelerated approval process and the FDA's approach to prescription drug advertising. He served as CEO of La Jolla Pharmaceuticals and Horizon Pharma, the latter of which he founded before Amgen bought it for $28 billion. Tidmarsh also founded Threshold Pharmaceutical, and held senior positions at other biotech companies.
"Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development—from bench to bedside," said FDA Commissioner Dr. Marty Makary, in a statement. "His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency."
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

'Significant evidence' ties air pollution with dementia, study finds
'Significant evidence' ties air pollution with dementia, study finds

UPI

time3 hours ago

  • UPI

'Significant evidence' ties air pollution with dementia, study finds

Smoke from fires in Northern California covers the Bay Bridge in San Francisco in 2020. A British study published this week appears to strengthen the suspected link between long-term exposure to air pollution and the risk of dementia in the elderly. File Photo by Terry Schmitt/UPI | License Photo ST. PAUL, Minn., July 24 (UPI) -- British researchers said Thursday they've found "significant evidence" of a long-suspected link between air pollution and dementia after studying data from nearly 30 million people across four continents. The authors of a paper published in The Lancet Planetary Health reviewed data compiled from 32 studies that involved more than 29 million participants, mostly from high-income countries in Europe, North America and Asia, as well as Australia, to "provide more robust overarching conclusions" about the suspected connection. After crunching the numbers from those studies, University of Cambridge researchers said they had identified a "positive and statistically significant association" between dementia and long-term exposure to three types of air pollutants: fine particulate matter with diameters of 2.5 microns or less, nitrogen dioxide, and soot from sources such as vehicle exhaust emissions and burning wood. They also concluded the risks of dementia go up as the levels of exposure increase, especially for the tiny particulate matter, which is so small it can be inhaled deeply into the lungs. For such "PM2.5," every 10 micrograms per cubic meter (μg/m³) of long-term exposure increases an individual's relative risk of dementia by 17%, they found. To put that into perspective, they noted the average roadside measurement for PM2.5 in central London in 2023 was 10 μg/m³. Similarly, for every 10 μg/m³ of long-term exposure to nitrogen dioxide, the relative risk of dementia increased by 3%, while the dementia risk jumped by 13% for each 1 μg/m³ of soot exposure. The study, which was funded by the European Union's scientific research arm, also noted that while traffic-related air pollution is common in cities in high-income countries, "marginalized groups" from low- and middle-income nations and communities not included in the analysis tend to have higher exposures to air pollution and are likely at even greater risk. Senior author Dr. Haneen Khreis of Cambridge's MRC Epidemiology Unit said the findings provide "further evidence to support the observation that long-term exposure to outdoor air pollution is a risk factor for the onset of dementia in previously healthy adults." She added that the mounting evidence makes the case for cleaner air even stronger -- not only for the sake of human health but also for the ability of care systems to cope with the exploding numbers of Alzheimer's disease and other types of dementia. The 57 million people already affected worldwide are expected to almost triple to 153 million cases by 2050, and reducing that avalanche of future illness will require "less burning of fossil fuels, a move to renewable clean energy, a move to clean transportation options, such as walking and cycling, and enacting climate change mitigation strategies," Khreis told UPI in emailed comments. "A coordinated effort would be a multisector, systems-level response -- not unlike how we've approached other public health crises." She and her Cambridge colleagues two years ago created an interactive "evidence map" of hundreds of possible urban policy interventions available by geography to reduce traffic-related emissions and air pollution, which they set up as an aid for planners to become aware of options of which they may not have been previously aware. "There are indeed many options available," Khreis said. "But in short, we need a whole-of-government and whole-of-society approach that views air pollution mitigation as an upstream intervention for brain health, and so many other outcomes that are now convincingly linked to air pollution. We need political will and courage to address this health hazard." Suspected in brain inflammation Scientists has been seeking to establish a definitive link between air pollution and dementia for a decade, as several previous studies have suggested such a connection. For instance, the British government's Committee on the Medical Effects of Air Pollutants reviewed nearly 70 studies in human populations and reported in 2022 that "it is likely that air pollution does contribute" to a decline in mental ability and dementia in older people, although they qualified that more research is needed before recommendations could be issued "with confidence." The 2024 Lancet Commission on dementia prevention, intervention and care, meanwhile, identified air pollution as one of 14 modifiable risk factors for dementia. Most theories about the link center around how air pollution can trigger inflammation in the brain and "excessive oxidative stress," in which the body's ability to combat free radicals with antioxidants is overwhelmed. There is "a wealth of expanding literature that investigates this question," Khreis said, noting that some research indicates the ultrafine particles may be able to bypass the blood-brain barrier and enter the brain directly via the olfactory nerve, thus triggering inflammation. Indirectly, these inhaled pollutants can trigger systemic inflammation and immune responses, such as when they enter the circulatory system and travel to solid organs. The particles can cross into the brain and disrupt microglial function and promote amyloid-β plaque formation, which is associated with dementia, she said. Experts comment Experts and other researchers who have looked at the possible link between air pollution and dementia, but were not connected to the current study, weighed on its findings when contacted by UPI. Dr. Isolde Radford, senior policy manager at the British charitable group Alzheimer's Research U.K., agreed that air pollution "is not just an environmental issue -- it's a serious and growing threat to our brain health. If no one were exposed to air pollution, there would be three fewer cases of dementia for every 100 people who develop it now." She called the current study a "rigorous review [that] adds to mounting evidence that exposure to air pollution -- from traffic fumes to wood burners -- increases the risk of developing dementia," and specifically noted marginalized groups are often exposed to higher levels of pollution, yet remain underrepresented in research. "Future studies must reflect the full diversity of society -- because those most at risk could stand to benefit the most from action," Radford added, calling on the British government to institute a "bold, cross-government approach to health prevention -- one that brings together departments beyond health ... to take coordinated action on the drivers of dementia risk" and move up existing timelines to produce cleaner air. Dr. Hao Chen, a researcher at Guangdong Provincial People's Hospital in China and author of a recent study linking atmospheric pollutants with the progression of cardiometabolic disorders and subsequent dementia, called the Cambridge paper an important document. "This is a landmark study that significantly advances our understanding of the link between air pollution and dementia," he told UPI in emailed comments, noting it is "the largest and most comprehensive meta-analysis to date, significantly advancing previous reviews by including new pollutants and rigorous bias/certainty assessments." It reinforces the findings of the 2024 Lancet Commission, he said, adding, "The public health implications are profound. The findings suggest that efforts to reduce air pollution -- particularly from traffic and industrial sources -- could play a crucial role in lowering the global burden of dementia. "Investing in cleaner air is not only beneficial for respiratory and cardiovascular health; it is a critical investment in protecting our brain health and cognitive longevity. This research provides a compelling, evidence-based mandate for policymakers worldwide to implement stricter air quality standards as an urgent dementia prevention strategy," Chen said. Victoria Williams, an assistant professor of geriatrics and gerontology, and noted Alzheimer's disease researcher at the University of Wisconsin, said the findings suggest "a moderate level of certainty that outdoor air pollution exposure increases risk for dementia, with the studies included considered to be at minimal risk for bias." Since there is currently no cure for dementia, "prevention is key to reducing its overall incidence in our society," she added. "Thus, minimizing exposure to air pollution does reflect a promising strategy in reducing the overall burden of dementia," and unlike other known risk factors linked to lifestyle choices such as smoking and a poor diet, societal action could make a difference. "Limiting exposure to ambient air pollution is well adept to being addressed at a policy level where reductions can offer broad protective effects to a society as a whole," Williams said.

FDA closes investigation into deadly listeria outbreak
FDA closes investigation into deadly listeria outbreak

UPI

time5 hours ago

  • UPI

FDA closes investigation into deadly listeria outbreak

The Food and Drug Administration has closed an investigation into a listeria outbreak. It was responsible one death and at least 10 people being sickened. File Photo (2020) Jim Lo Scalzo/EPA July 24 (UPI) -- The Food and Drug Administration has closed an investigation into a listeria outbreak that killed one person and sickened 10 in several western states, health officials announced Thursday. People were sickened by the outbreak after consuming products produced by California-based Fresh & Ready Foods, officials announced Thursday. The recall applied to Ready-to-Eat products sold in Arizona, California, Nevada and Washington. Illnesses have been reported in California and Nevada. Dozens of items have been recalled, ranging from sandwiches and protein snacks to pasta dishes and croissants. "FDA is working with Fresh & Ready Foods on corrective and preventive actions," the FDA said in a statement. The recalled products were distributed between April 18th and April 28th in vending machines and breakrooms in corporate offices, medical buildings and healthcare facilities, the FDA said. The products had "Use By" dates between April 22nd and May19th. The FDA said it made the discovery during environmental testing at a production facility that turned up listeria on a piece of equipment. "Fresh & Ready Foods has taken immediate corrective actions including removing equipment to address this issue to ensure ongoing food safety and compliance with FDA guidelines," the statement continued.

100 days into the job, FDA Commissioner talks to CNN about staff changes, agency process— and Coke's switch to sugar
100 days into the job, FDA Commissioner talks to CNN about staff changes, agency process— and Coke's switch to sugar

CNN

time5 hours ago

  • CNN

100 days into the job, FDA Commissioner talks to CNN about staff changes, agency process— and Coke's switch to sugar

The US Food and Drug Administration is plowing ahead with sweeping plans to crack down on ultra processed foods and reshape the way new drugs and devices are reviewed and approved, the agency's commissioner, Marty Makary, told CNN in an interview this week. Makary sat down with CNN at the FDA's White Oak, Maryland campus, roughly 100 days into his tenure as the head of the agency that oversees vast portions of the US's food and health system: drugs, medical devices, tobacco and a portion of the food supply that accounts for roughly a fifth of the US economy. In the large, sunny room overlooking the courtyard at the center of the FDA's sprawling grounds, Makary put forth talking points he has often repeated on his podcast, 'FDA Direct'— a new feature for a commissioner. In a wide-ranging interview, he addressed everything from the agency's staffing changes to his thoughts on Coca-Cola's switch to real sugar. Makary, a gastrointestinal surgeon, took over the FDA just as broad layoffs and a slew of departures of experienced senior staff hit the agency amid changes orchestrated by DOGE, a White House efficiency group that attempted to reform the federal government through dramatic cuts. Makary was sworn in on the same day that the cuts took place, April 1. The FDA has since reinstated 'hundreds' of those terminated employees, Makary told CNN on Monday, and the waters have calmed since the layoffs. 'I want the public to know something very clear,' Makary said. 'The FDA is strong, and it will continue to be strong. The trains are running on time,' he said. 'We're going to meet all our targets this year,' he said, referring to the number of drugs and devices the FDA aims to evaluate by January. Such an achievement, if met, would be a relief for the US pharmaceutical industry, which has been watching cautiously as the agency overhauls its regulatory process, promising speedy new pathways for approvals. There has been skepticism. Earlier this year, hundreds of biotech executives had publicly lamented that FDA's leadership on science would be 'irretrievably lost' because of the April staffing losses. While scientists reviewing new drugs and devices were spared from cuts, administrative staff who aid their work were not. Since Makary assumed his post, the FDA also rolled out Elsa, a new artificial intelligence chatbot billed as a tool to help staff speed up clinical reviews and scientific evaluations. But Elsa has made up nonexistent studies and gotten facts wrong, according to six current and former FDA officials who spoke to CNN. Asked about the potential risks of AI-aided review, Makary said it is a work in progress. 'We never want to miss something that could be dangerous,' he said. 'It is a balancing act, and we've got to continue to try to do it.' The FDA is also a critical part of Health Secretary Robert F. Kennedy Jr.'s vision to 'Make America Healthy Again' through food policy reforms. This week, the US Department of Health and Human Services, which oversees the FDA, took a first major step toward regulating ultra processed foods by asking industry and scientific experts for feedback on how to define them. A major tenet of Kennedy's MAHA agenda is to remove artificial ingredients from foods, overhaul prescription drug use and tackle environmental toxins, all of which he believes are driving chronic illness among American children. Speaking to CNN, Makary laid out a framework for the FDA's broader food policy plans, including dramatic changes to the federal dietary guidelines, a compass for doctors, schools and families on the foods to eat and avoid. They are 'cleaning house' on the guidelines, Makary said. 'We're going to go bold on this because for too long, people have been confused, they've been misled.' 'We have a public trust epidemic in health care because in part people were lied to about what's healthy and what's not healthy,' he said — an assertion that would be highly disputed by experts who advise on the guidelines every five years. Moreover, the dietary guidelines are not entirely up to Makary and his agency. They'll have to hammer out the final recommendations by December with the US Department of Agriculture, and there has already been friction. Makary is also determined to see an end to what he called 'the 70-year war on natural saturated fat'— a substance, he says, that has 'never been found in any clinical trial to be directly associated with heart disease.' That claim is disputable. While Makary did not elaborate on which types of natural saturated fat have been demonized, as he put it, nutrition experts have said there are still significant and well-established harms to heart health from fats in red and processed meats. In dairy, different saturated fats are thought to have varied levels of risk and benefit. Makary's comments come as major food companies and fast-food chains scramble to position themselves as MAHA allies, promising to remove artificial ingredients and food dyes, and switch out seed oils for Kennedy's favored frying ingredient, beef tallow. Coca-Cola announced last week that it would start offering products with cane sugar rather than high-fructose corn syrup, news that was heralded by President Donald Trump. Experts say that is a marginal change; both are ultimately bad for your health. Asked about Coke's sugar announcement, Makary said, 'There are incremental benefits to the different types of sugar out there' but that 'I think it's a good switch.' There is more to come. The commissioner also said that FDA is 'doing an inventory' of more than 11,000 chemicals that are banned in Europe and other countries, but 'common' in the US food supply. Before coming to the FDA, Makary, a surgeon at Johns Hopkins University, was probably best known for a series of books on flaws in the health care system. He supported lockdowns and masking in the early days of the Covid-19 pandemic, but later became a prominent critic of vaccine requirements and booster shots. He argued in a February 2021 Wall Street Journal op-ed that the US would reach herd immunity by that April; instead, new waves of Covid strains hit the population. Those views did not exactly alienate Makary from the medical establishment or Washington's political world. Three Democratic senators voted to confirm him, making him the only one of Trump's health nominees to win Democratic votes in this administration. 'The day before my Senate confirmation hearing, I was in the operating room. So this is an entirely different domain for me,' Makary said. Sandee LaMotte contributed to this report.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store