Latest news with #MartyMakary
Yahoo
4 hours ago
- Health
- Yahoo
FDA's Makary wants to increase drug access, reduce 'addictive' foods
FDA Commissioner Marty Makary has an ambitious plan to overhaul how quickly patients can access drugs in the US, but also wants to reduce reliance on pharmaceuticals by shifting the focus of research to finding the root causes of common diseases. At the top of his list is reducing Americans' consumption of ultra-processed foods and making subsidized federal food programs healthier. "No one has been talking about the fact that food has been designed to be addictive. So when we have a crisis in our nation's children, that is, 40% have a chronic disease and 31% have prediabetes or insulin resistance, it's not their fault," Makary told Yahoo Finance in an interview Wednesday. "We don't think that our childhood obesity epidemic is a willpower problem. We think this is something adults are doing to kids," Makary added. He spoke with Yahoo Finance while on a nationwide tour to connect with drug industry leaders at companies big and small. But while Makary is focused on streamlining access to medicines and allowing access to some that may not be fully tested in traditional clinical trials, he is also focused on reducing the use of drugs in daily life. "We've got to talk about school lunch programs, not just putting every 6-year-old on Ozempic," Makary said, referencing the blockbuster diabetes drug from Novo Nordisk (NVO). "We've got to talk about sleep medicine and the quality of sleep, not just antihypertensive after antihypertensive [drugs that treat high blood pressure]. And we've gotta talk about environmental exposures that cause cancer, not just the chemo to treat it. We've got to talk about food as medicine and the microbiome," Makary said. He has also been vocal about revamping the food pyramid, which hasn't been updated in more than a decade, and sees it as one path to regaining trust in the agency — which has declined in the years since the pandemic. "We are going to rewrite those dietary guidelines. I think that'll go a long way too in rebuilding trust," Makary said. Research and rebuilding trust In addition to the FDA's work in addressing chronic diseases, the National Institutes of Health (NIH) are also directing funds to do the same. When asked about cuts to health equity-focused research, including women's health, Makary defended the Trump administration's moves to cut some federally funded research, to the tune of $18 billion, or a 40% reduction. "The NIH, when we came into office, was a mess. Fourteen percent of grants went to descriptive studies on health equity, not reducing health equities." Meanwhile, Makary has been focused on ensuring quicker access to drugs, questioning why it takes 10 years for a drug to reach market, and more transparency about drugs that are approved. He did not specify when the public would get greater access to decision letters, but continued to promise more access. "We're releasing the FDA decision letters so the public can see them, drug developers can see them. We can give more predictability. We're modernizing the agency. We're trying to cut some of the idle time," Makary said, noting this was key to rebuilding trust as well. Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, provider services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee as AnjKhem on social media platforms X, LinkedIn, and Bluesky @AnjKhem. Click here for in-depth analysis of the latest health industry news and events impacting stock prices
Yahoo
4 hours ago
- Health
- Yahoo
FDA's Makary wants to increase drug access, reduce 'addictive' foods
FDA Commissioner Marty Makary has an ambitious plan to overhaul how quickly patients can access drugs in the US, but also wants to reduce reliance on pharmaceuticals by shifting the focus of research to finding the root causes of common diseases. At the top of his list is reducing Americans' consumption of ultra-processed foods and making subsidized federal food programs healthier. "No one has been talking about the fact that food has been designed to be addictive. So when we have a crisis in our nation's children, that is, 40% have a chronic disease and 31% have prediabetes or insulin resistance, it's not their fault," Makary told Yahoo Finance in an interview Wednesday. "We don't think that our childhood obesity epidemic is a willpower problem. We think this is something adults are doing to kids," Makary added. He spoke with Yahoo Finance while on a nationwide tour to connect with drug industry leaders at companies big and small. But while Makary is focused on streamlining access to medicines and allowing access to some that may not be fully tested in traditional clinical trials, he is also focused on reducing the use of drugs in daily life. "We've got to talk about school lunch programs, not just putting every 6-year-old on Ozempic," Makary said, referencing the blockbuster diabetes drug from Novo Nordisk (NVO). "We've got to talk about sleep medicine and the quality of sleep, not just antihypertensive after antihypertensive [drugs that treat high blood pressure]. And we've gotta talk about environmental exposures that cause cancer, not just the chemo to treat it. We've got to talk about food as medicine and the microbiome," Makary said. He has also been vocal about revamping the food pyramid, which hasn't been updated in more than a decade, and sees it as one path to regaining trust in the agency — which has declined in the years since the pandemic. "We are going to rewrite those dietary guidelines. I think that'll go a long way too in rebuilding trust," Makary said. Research and rebuilding trust In addition to the FDA's work in addressing chronic diseases, the National Institutes of Health (NIH) are also directing funds to do the same. When asked about cuts to health equity-focused research, including women's health, Makary defended the Trump administration's moves to cut some federally funded research, to the tune of $18 billion, or a 40% reduction. "The NIH, when we came into office, was a mess. Fourteen percent of grants went to descriptive studies on health equity, not reducing health equities." Meanwhile, Makary has been focused on ensuring quicker access to drugs, questioning why it takes 10 years for a drug to reach market, and more transparency about drugs that are approved. He did not specify when the public would get greater access to decision letters, but continued to promise more access. "We're releasing the FDA decision letters so the public can see them, drug developers can see them. We can give more predictability. We're modernizing the agency. We're trying to cut some of the idle time," Makary said, noting this was key to rebuilding trust as well. Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, provider services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee as AnjKhem on social media platforms X, LinkedIn, and Bluesky @AnjKhem. Click here for in-depth analysis of the latest health industry news and events impacting stock prices Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Independent
7 hours ago
- Health
- The Independent
FDA looking to make vapes less addictive as agency head claims 85% of those sold are ‘illegal'
The Food and Drug Administration (FDA) says it is taking significant steps to make vaping less addictive, with its commissioner likening a synthetic byproduct found in some products to an opioid. Vapes or e-cigarettes are the most commonly used tobacco product among American youths, and there is growing concern about addiction. The agency has formally recommended that the Drug Enforcement Administration (DEA) classify certain 7-hydroxymitragynine (7-OH) products under the Controlled Substances Act. Speaking to Newsmax, FDA Commissioner Marty Makary said there is a widespread problem with illicit vaping products. 'First of all, 85 percent of vaping products sold at your local vape shop are illegal,' he told Rob Schmitt Tonight. 'These are products that are even banned in China, where they come from. They've got these cutesy, fruity flavours or even a video game [that is] part of the vape device designed to addict kids.' Makary went on to condemn these products as 'predatory' and warned of a growing 'epidemic,' noting that 'at some high schools, a quarter of the kids are using these vaping products regularly. So, we've got an epidemic we've got to address,' he said. The substance 7-OH, described by Makary as an opioid, is a derivative of kratom, a South Asian tree. While kratom leaves can produce stimulant effects at low doses and sedative effects at higher doses, the DEA warns they can also lead to psychotic symptoms and both psychological and physiological dependence. Makary issued a stark warning to parents: 'You can walk down to many of these vape stores or convenience stores or gas stations and buy an opioid today.' He added: 'Parents need to know about this. And we recommended the DEA starts to schedule this as a controlled substance. And that's something that's inside of these vapes.' Makary clarified the FDA's focus, explaining: ' Kratom has a trace amount of 7-OH. We're not focused on that. We're focused on the synthetic concentrated byproduct.' According to data from the Centers for Disease Control and Prevention, the use of e-cigarettes was the most commonly used tobacco product among middle and high school students in the United States in 2024. A total of 1.63 million (5.9 percent) students currently use them, including 410,000 (3.5 percent) middle school pupils and 1.21 million (7.8 percent) high school students. Of these, 87.6 percent reported using flavoured e-cigarettes, with disposable e-cigarettes the most popular choice at 55.6 percent, followed by prefilled or refillable pods (15.6 percent) and tank or mod systems (7 percent). According to Johns Hopkins Medicine, evidence shows that vaping is less harmful than smoking, as it exposes users to fewer toxins and at lower levels than smoking cigarettes. However, vapes are just as addictive as traditional cigarettes, as many users get even more nicotine than they would from a combustible tobacco product because users can buy extra-strength cartridges or increase the e-cigarette's voltage to get a greater hit of the substance.
Yahoo
8 hours ago
- Health
- Yahoo
US health officials crack down on kratom-related products after complaints from supplement industry
WASHINGTON (AP) — U.S. health officials are warning Americans about the risks of an opioid-related ingredient increasingly added to energy drinks, gummies and supplements sold at gas stations and convenience stores, recommending a nationwide ban. The chemical, known as 7- hydroxymitragynine, is a component of kratom, a plant native to Southeast Asia that has gained popularity in the U.S. as an unapproved treatment for pain, anxiety and drug dependence. In recent months, dietary supplement companies that sell kratom have been urging the Food and Drug Administration to crack down on the products containing 7-OH, portraying it as a dangerously concentrated, synthetic form of the original ingredient. The FDA action 'is not focused on natural kratom leaf products," according to a statement Tuesday by the U.S. Department of Health and Human Services. The agency said it was releasing a report to educate about the risks of '7-OH and its distinction from the kratom plant leaf.' Regulators are also recommending that the ingredient be placed on the federal government's most restrictive list of illegal drugs, which includes LSD and heroin. '7-OH is an opioid that can be more potent than morphine," said FDA Commissioner Marty Makary. "We need regulation and public education to prevent another wave of the opioid epidemic.' The agency's recommendation will be reviewed by the Drug Enforcement Administration, which sets federal rules for high-risk drugs including prescription medicines and illicit substances. A national ban wouldn't take effect until the agency drafts and finalizes new rules governing the ingredient. Federal regulators have been scrutinizing kratom for about a decade after reports of addiction, injury and overdose. But users and distributors have long opposed efforts to regulate it, saying kratom could be a safer alternative to opioid painkillers that sparked the ongoing drug addiction epidemic. Last month, the FDA issued warning letters to seven companies selling drinks, gummies and powders infused with 7-OH. Regulators said the products violated FDA rules because they have not been evaluated for safety and, in some cases, claimed to treat medical conditions, including pain, arthritis and anxiety. Supplement executives quickly applauded the move. The FDA "demonstrated the exact kind of data-driven, proactive regulatory excellence needed to safeguard unwitting consumers across the U.S.,' said Ryan Niddel of Diversified Botanics, a Utah-based company that sells kratom supplements. An industry group, the American Kratom Association, has lobbied Congress for years against restrictions on the plant. Legislation supported by the group would prohibit the FDA from regulating kratom more strictly than food and dietary supplements. In recent years, the association has lobbied at the state level for bills that limit synthetic 7-OH products. On Tuesday, a rival group that supports the availability of 7-OH drugs criticized the government's move, pointing to the influence of kratom suppliers. 'Big kratom trade groups have spent years blaming 7-OH for harms caused by their own unregulated products, because it threatens their market share,' the Holistic Alternative Recovery Trust stated in an emailed message. Nearly a decade ago, the federal government came close to banning kratom. In 2016, the DEA announced plans to add it to the government's most restrictive schedule 1, reserved for drugs that have no medical use and a high potential for abuse. But the plan stalled after a flood of public complaints, including a letter signed by more than 60 members of Congress. The FDA then began studying the ingredient, concluding in 2018 that kratom contains many of the same chemicals as opioids, the addictive class of drugs that includes painkillers like OxyContin as well as heroin and fentanyl. Since then, FDA regulators have continued to issue warnings about cases of injury, addiction and death with kratom supplements, which are usually sold in capsules or powders. In recent months, the FDA has also issued warnings on other unapproved drugs sold as supplements or energy drinks, including the antidepressant tianeptine. Sometimes referred to collectively as 'gas station heroin,' the drugs have been restricted by several states, but they are not scheduled at the federal level. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. Matthew Perrone, The Associated Press
CNBC
11 hours ago
- Health
- CNBC
FDA Commissioner Dr. Marty Makary: The agency could hit a record number of approvals this year
FDA Commissioner Dr. Marty Makary joins 'Squawk Box' to discuss his meeting with CEOs of major pharmaceutical and biotech companies, streamlining the drug approval process, the departure of Dr. Vinay Prasad, the agency's probe on Sarepta, vaccine injury reports, crackdown of Kratom derivative 7-OH, and more.
