Latest news with #FoodandDrugs
Yahoo
03-06-2025
- Business
- Yahoo
FDA commissioner pledges to investigate mifepristone
Food and Drug Administration Commissioner Marty Makary committed to reviewing the abortion drug mifepristone in a letter sent to Senator Josh Hawley (R-Mo.). 'As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy,' Makary wrote to Hawley. 'As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data,' he added in the letter. Makary did not provide any further details about the forthcoming review since the abortion drug is a part of ongoing litigation. Hawley has previously pressured the agency to review the drug. Last month, the senator sent a letter to Makary urging him to review new data released on mifepristone and to 'restore critical safeguards' on the drug's use. In the same letter, he also criticized Makary for stating that he has 'no plans to take action' on mifepristone during a journalism convention. The data Hawley referred comes from a study published in April by The Ethics and Public Policy Center, a conservative think tank with a mission to 'pushback against the extreme progressive agenda.' The group claims that nearly 11 percent of women who undergo an abortion using mifepristone experience a 'serious adverse event,' which is a far higher rate than the 0.5 percent rate determined in other clinical studies. But the study is deeply flawed and filled with what researchers have called 'junk science.' The study does not clearly state the database where it obtained the nearly 865,000 insurance claims on prescribed mifepristone abortions. The research breaks down the 'serious adverse events' by category but places the majority of those events into a vague category called 'other abortion-specific complications.' The FDA first approved the use of mifepristone for an abortion as part of two-drug regimen with misoprostol in 2000. Medication abortions do not need to take place in a clinic setting with patients able to pick up the pills at a clinic to then take home or receive them in the mail. More than 100 scientific studies have been conducted examining the safety and efficacy of mifepristone and misoprostol, with all of them finding that the drugs are a safe way to end a pregnancy. Most abortions in the U.S. are medication abortions. In 2023, 63 percent of all abortions provided by clinicians in the country were medication abortions, according to data from the reproductive health and rights group the Guttmacher Institute. Three Republican-led states — Idaho, Missouri and Kansas — filed a lawsuit against the FDA challenging its previous approval of mifepristone. The Supreme Court dismissed the case last year, arguing that private parties did not have a legal basis to challenge access to the drug. But a Texas federal judge ruled in January that the three states could resume their lawsuit aimed at restricting access to mifepristone. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has also pushed for a review of the drug. President Trump, after winning the election last November, said it was 'unlikely' that he would revoke access to the drug. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
03-06-2025
- Business
- The Hill
FDA commissioner pledges to investigate mifepristone
Food and Drug Administration Commissioner Marty Makary committed to reviewing the abortion drug mifepristone in a letter sent to Senator Josh Hawley (R-Mo.). 'As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy,' Makary wrote to Hawley. 'As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data,' he added in the letter. Makary did not provide any further details about the forthcoming review since the abortion drug is a part of ongoing litigation. Hawley has previously pressured the agency to review the drug. Last month, the senator sent a letter to Makary urging him to review new data released on mifepristone and to 'restore critical safeguards' on the drug's use. In the same letter, he also criticized Makary for stating that he has 'no plans to take action' on mifepristone during a journalism convention. The data Hawley referred comes from a study published in April by The Ethics and Public Policy Center, a conservative think tank with a mission to 'pushback against the extreme progressive agenda.' The group claims that nearly 11 percent of women who undergo an abortion using mifepristone experience a 'serious adverse event,' which is a far higher rate than the 0.5 percent rate determined in other clinical studies. But the study is deeply flawed and filled with what researchers have called 'junk science.' The study does not clearly state the database where it obtained the nearly 865,000 insurance claims on prescribed mifepristone abortions. The research breaks down the 'serious adverse events' by category but places the majority of those events into a vague category called 'other abortion-specific complications.' The FDA first approved the use of mifepristone for an abortion as part of two-drug regimen with misoprostol in 2000. Medication abortions do not need to take place in a clinic setting with patients able to pick up the pills at a clinic to then take home or receive them in the mail. More than 100 scientific studies have been conducted examining the safety and efficacy of mifepristone and misoprostol, with all of them finding that the drugs are a safe way to end a pregnancy. Most abortions in the U.S. are medication abortions. In 2023, 63 percent of all abortions provided by clinicians in the country were medication abortions, according to data from the reproductive health and rights group the Guttmacher Institute. Three Republican-led states — Idaho, Missouri and Kansas — filed a lawsuit against the FDA challenging its previous approval of mifepristone. The Supreme Court dismissed the case last year, arguing that private parties did not have a legal basis to challenge access to the drug. But a Texas federal judge ruled in January that the three states could resume their lawsuit aimed at restricting access to mifepristone. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has also pushed for a review of the drug. President Trump, after winning the election last November, said it was 'unlikely' that he would revoke access to the drug.
Reuters
22-05-2025
- Business
- Reuters
Trump proposing $6.8 bln budget for US FDA, commissioner says
WASHINGTON, May 22 (Reuters) - The Trump administration is proposing a $6.8 billion budget request for the U.S. Food and Drug Administration for the 2026 fiscal year, Commissioner of Food and Drugs Martin Makary said on Thursday. "The Trump administration is proposing a $6.8 billion budget for the FDA, including $3.2 billion in budget authority and 3.6 billion in user fees for fiscal year 2026," Makary told a U.S. Senate panel. "This allows us to take the necessary steps to support the Make America healthy again agenda, as we have already been busy implementing," he said at a hearing of the Senate Appropriations Committee's Subcommittee on Labor, Health and Human Services, Education, and Related Agencies to discuss the agency's portion of Trump's budget request.
Toronto Sun
12-05-2025
- Business
- Toronto Sun
Sen. Paul points to business-sector resistance to Trump's tariffs in solidly red Kentucky
Published May 12, 2025 • 3 minute read Sen. Rand Paul, R-Ky., speaks during the Senate Committee on Health, Education, Labor and Pensions hearing on the nomination of Martin Makary to serve as Commissioner of Food and Drugs at the Department of Health and Human Services, on Capitol Hill Thursday, March 6, 2025, in Washington. Photo by Jose Luis Magana / AP LOUISVILLE, Ky. — In solidly Republican Kentucky, resistance to President Donald Trump's trade wars has sprung up from a cross-section of key business sectors, GOP Sen. Rand Paul said Monday. This advertisement has not loaded yet, but your article continues below. THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLY Subscribe now to read the latest news in your city and across Canada. Unlimited online access to articles from across Canada with one account. Get exclusive access to the Toronto Sun ePaper, an electronic replica of the print edition that you can share, download and comment on. Enjoy insights and behind-the-scenes analysis from our award-winning journalists. Support local journalists and the next generation of journalists. Daily puzzles including the New York Times Crossword. SUBSCRIBE TO UNLOCK MORE ARTICLES Subscribe now to read the latest news in your city and across Canada. Unlimited online access to articles from across Canada with one account. Get exclusive access to the Toronto Sun ePaper, an electronic replica of the print edition that you can share, download and comment on. Enjoy insights and behind-the-scenes analysis from our award-winning journalists. Support local journalists and the next generation of journalists. Daily puzzles including the New York Times Crossword. REGISTER / SIGN IN TO UNLOCK MORE ARTICLES Create an account or sign in to continue with your reading experience. Access articles from across Canada with one account. Share your thoughts and join the conversation in the comments. Enjoy additional articles per month. Get email updates from your favourite authors. THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK. Create an account or sign in to continue with your reading experience. Access articles from across Canada with one account Share your thoughts and join the conversation in the comments Enjoy additional articles per month Get email updates from your favourite authors Don't have an account? Create Account Paul said he's heard concerns from agriculture, the auto sector, bourbon production, home building and package shipping in response to Trump's aggressive use of tariffs. Paul — among the few GOP senators willing to challenge Trump on tariffs — met with a group of Louisville business leaders on Monday. 'Virtually every business that I have met in Kentucky has said they're not excited about having tariffs and that international trade has been good for their company and good for the consumer by bringing lower prices,' the libertarian-leaning Paul told reporters afterward. Paul welcomed the sudden de-escalation of the trade conflict between the U.S. and China, when the two global economic powerhouses agreed Monday to slash their massive recent tariffs. The 90-day truce creates time for U.S. and Chinese negotiators to reach a more substantive agreement. Your noon-hour look at what's happening in Toronto and beyond. By signing up you consent to receive the above newsletter from Postmedia Network Inc. Please try again This advertisement has not loaded yet, but your article continues below. As for prospects of a longer-term deal, the senator said: 'We'll see how it shakes out.' 'Anything we can do to bring down tariffs is good,' Paul said. 'I said I'll be the first person to compliment President Trump if the end of this shakes out and in six months, all the tariffs are lower and there's more trade. I'm perfectly willing and big enough to say: 'Good job, Mr. President.'' Trump used tariffs in his first term and has been even more aggressive and unpredictable about imposing them in his second. He's slapped a 10% tariff on a myriad of countries, blowing up the rules that had governed global trade for decades. Trump dominated Kentucky in each presidential election since 2016, but the GOP lawmakers willing to speak out against his trade wars include Paul and Sen. Mitch McConnell. Trump's tariffs forged a rare bipartisan alliance in Kentucky among the senators and Democratic Gov. Andy Beshear. They raised concerns that trade wars would drive up prices for consumers and damage key business sectors, including the bourbon industry. In Canada, some liquor stores cleared American spirits from their shelves amid trade acrimony and Trump's calls to make Canada the 51st state. This advertisement has not loaded yet, but your article continues below. Trump views tariffs as an all-purpose economic tool that can raise money for the U.S. Treasury, protect American industries, lure factories to the United States and pressure other countries to bend to his will, even on issues such as immigration and drug trafficking. Paul, who ran for president in 2016, has called for Congress to reassert its authority on the issue. 'Tariffs are taxes, and the power to tax belongs to Congress — not the president,' Paul said in a release last month. 'Our Founders were clear: tax policy should never rest in the hands of one person.' Asked Monday if he trusts the president's tactics on trade, Paul replied: 'I would prefer we weren't putting tariffs on.' Paul also raised concerns about the on-again, off-again nature of Trump's tariff policies, noting that 'businesses like certainty.' 'It's really why most of us who believe in the free market think that government shouldn't be involved in so many decisions,' he said. 'These are the decisions that should be left to the marketplace to determine prices.' This advertisement has not loaded yet, but your article continues below. Among the business leaders who met with Paul on Monday was Sarah Davasher-Wisdom, CEO of Greater Louisville Inc., the metro chamber of commerce in Kentucky's largest city. Participants updated the senator on what impacts the tariffs are having on their businesses, she told reporters. 'The tariffs are creating a lot of uncertainty for businesses, and that makes it very difficult to operate. And it's driving up prices,' she said. 'And the uncertainty itself is making it difficult for businesses to plan capital expenditures, making it difficult for them to plan out 90 days, 120 days.' Columnists Toronto Maple Leafs Editorial Cartoons Toronto & GTA World
Yahoo
09-05-2025
- Health
- Yahoo
FDA issues warning against tianeptine use, also called 'gas station heroin'
This article discusses suicidal ideation. If you or someone you know is struggling or in crisis, help is available. Call or text 988 or chat at The U.S. Food and Drug Administration is warning the public about a drug rising in popularity, commonly referred to as "gas station heroin." Tianeptine poses a "dangerous and growing health trend" across the U.S., particularly putting young people at risk, Food and Drugs Commissioner Dr. Marty Makary said in a May 8 news release. No use of the drug has received FDA approval as it can result in serious harm or death, Makary clarified. He emphasized the public must address the trend before it becomes the latest example of delayed recognition patterns previously seen in opioid abuse and youth vaping. "I am very concerned. I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America's youth," Makary said. "While the FDA is closely following the distribution and sale of these products, it is critical that you appreciate the magnitude of the underlying danger of these products, and disseminate information about it." Here's what to know about tianeptine. Tianeptine has been banned in 10 U.S. states: Alabama Florida Georgia Indiana Kentucky Michigan Mississippi Ohio Tennessee North Carolina Makary said tianeptine is sold under various product names, including Tianaa, Zaza, Neptune's Fix, Pegasus and TD Red. Tianeptine is licensed in some countries and marketed as an atypical antidepressant meant to treat depression through three daily 12.5 mg oral doses, according to Makary. "Higher doses can produce euphoria, and some countries have restricted how tianeptine is prescribed and dispensed or revised the drug label to warn of possible addiction," Makary said. "FDA recommends that health care professionals encourage patients to avoid all products containing tianeptine, including those claiming to treat an ailment or disorder." Tianeptine is prescribed as an antidepressant in some European, Asian and Latin American countries, but it's not approved for any medical use in the U.S. Still, companies are marketing and selling tianeptine products as dietary supplements typically in pill and powder form, claiming it can improve brain function and treat depression, anxiety, pain and even opioid use disorder. The drug is typically available gas stations, convenience stores, vape shops and online retailers, according to the FDA. While many use tianeptine to treat their ailments and assume they are safe because of their availability. However, the FDA said tianeptine is a prime example of availability not indicating effectiveness or safety. Tianeptine has been banned in Alabama, Florida, Georgia, Indiana, Kentucky, Michigan, Mississippi, Ohio and Tennessee. According to the Cleveland Clinic, tianeptine is addictive. In an April 2024 interview with USA TODAY, Alabama woman Chrissy Reifschneider said she tried tianeptine pills after a family member who worked at a gas station recommended them to her. Within days, she said she became addicted to the drug, and experienced three gruesome years. Reifschneider said she took about five pills every four hours in which she experienced hair loss, weight loss, auditory hallucinations; developed paranoia surrounding electronics and suicidal ideations. "I thought well, I'm not sticking a needle in my arm, so I literally convinced myself that I wasn't a drug addict until I realized I didn't recognize who I was anymore," Reifschneider, who is now sober, told USA TODAY last year. "It's crazy to think that these gas station pills just controlled me. I was ashamed because I'd rather people know I was shooting up heroin than actually spending all this time and money on over-the-counter (drugs)." The FDA lists the following adverse events reported in people who ingested tianeptine. Agitation Confusion Drowsiness Nausea Sweating Vomiting Tachycardia Hypertension Respiratory depression Coma Death The FDA also said some symptoms of tianeptine withdrawal are similar to opioid discontinuation, including: Craving Sweating Goose flesh or goosebumps Diarrhea Muscle aches and pain Contributing: Katie Camero This article originally appeared on USA TODAY: Gas station heroin: FDA warns public of tianeptine use
