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The U.S. Food and Drug Administration announced approval of leucovorin, a form of folic acid that U.S. President Donald Trump was slated to suggest as a treatment for autism symptoms at a White House event on Monday. GSK (GSK.L), opens new tab previously manufactured leucovorin and sold it under the name Wellcovorin. The company withdrew the drug from the market, but not for reasons of safety or effectiveness. The Federal Register notice cited "patient-level data on over 40 patients, including both adults and pediatric patients" to support the finding that the drug can improve symptoms from cerebral folate deficiency (CFD). According to the Federal Register entry, CFD has been reported in patients with neuropsychiatric symptoms, including autistic features.

U.S. Food and Drug Administration Commissioner Martin Makary said on Friday that Hims & Hers' (HIMS.N), opens new tab Super Bowl advertisement breached federal law as it highlighted the benefits of weight-loss drugs without mentioning side effects. Under federal law, advertisements for prescription drugs must present a "fair balance" of risks and benefits, Makary said in JAMA, opens new tab, a peer-reviewed medical journal published by the American Medical Association. Get a quick look at the days breaking legal news and analysis from The Afternoon Docket newsletter. Sign up here. He also highlighted a sharp drop in FDA enforcement, saying the agency used to issue hundreds of warning letters annually in the late 1990s compared with just one in 2023 and none in 2024. A Hims & Hers spokesperson said the company's "Super Bowl ad did not advertise any one treatment or solution." "Rather, it aimed to raise awareness to a critical issue – the obesity public health crisis – by showcasing the impact of obesity and the realities of the lack of access to life-saving holistic weight loss care," the spokesperson said in an emailed statement. The FDA's latest move follows a presidential memorandum signed by Donald Trump on Tuesday, urging his administration to...

The U.S. Food and Drug Administration will send out around 100 cease-and-desist enforcement notices and thousands of letters warning pharmaceutical companies that direct-to-consumer ads must comply with regulations that are already on the books, senior administration officials said on Tuesday. The FDA plans to enforce regulations stipulating that drug ads cannot create a misleading impression about the products and need to appropriately disclose side effects, the officials said. Make sense of the latest ESG trends affecting companies and governments with the Reuters Sustainable Switch newsletter. Sign up here. "There are ads that are clearly crossing the line with respect to the regulation, making any potential future legal action, I think, pretty clear cut," one of the officials said. U.S. President Donald Trump also signed a presidential memorandum on Tuesday afternoon, the White House said, calling on his administration to step up enforcement of direct-to-consumer (DTC) pharmaceutical ads in order to ensure transparency and accuracy. "Pharmaceutical ads hooked this country on prescription drugs," U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement. "We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising." PhRMA, the industry's main lobby group, said drugmakers...

The U.S. Food and Drug Administration has approved Johnson & Johnson's (JNJ.N), opens new tab drug delivery system for patients with a type of bladder cancer, the drugmaker said on Tuesday, offering a potential alternative to surgically remove the organ. The drug release system, branded as Inlexzo, was approved for patients with a type of high-risk non-muscle invasive bladder cancer who did not respond to treatment with Bacillus Calmette-Guerin (BCG) therapy, the current standard-of-care, and are ineligible for, or refuse to undergo bladder removal surgery. About 75% of bladder cancer cases are non-muscle-invasive at the time of diagnosis, according to government data. The approval was based on data from a mid-stage study, in which more than 82% of the patients showed no signs of cancer after three months and over half of them remained cancer-free at least for a year after the treatment with Inlexzo. "This drug, at ultra low doses for long periods of time... behaves in a way that not only pushes the disease into remission, but then maintains it through some immune memory," Christopher Cutie, vice president and disease area leader for bladder cancer, at J&J, told Reuters ahead of the FDA decision. Inlexzo, also known as TAR-200, is inserted directly...

The U.S. Food and Drug Administration will hold an advisory panel meeting in November to examine the fast-emerging class of AI-enabled digital mental health devices. The agency's Digital Health Advisory Committee will meet on November 6 and focus on how these digital tools could help address a widening gap in access to mental health services in the United States, while also probing the unique risks they pose. There has been a sharp growth in AI-enabled digital mental health tools from chatbots to virtual therapists. While these technologies promise reach, scalability and timely intervention, regulators are grappling with how to ensure such devices are both effective and safe. The FDA itself has begun experimenting with AI in its review work. The DHAC meeting aims to set the groundwork for identifying key areas of concern and potential regulatory pathways, according to a document published on Thursday. DHAC's charge is to advise the FDA on regulatory issues surrounding digital health technologies including AI/ML, remote patient monitoring, digital therapeutics and software components of medical devices. The agency has opened a public docket for comments ahead of the session. Background materials will be posted online at least two business days before the meeting.

U.S. authorities have seized 4.7 million unauthorized e-cigarettes valued at $86.5 million in the largest operation of its kind to date, the Department of Health and Human Services said on Wednesday. The seizures, led by the U.S. Food and Drug Administration and U.S. Customs and Border Protection, were part of a joint federal operation in Chicago aimed at intercepting illegal e-cigarette shipments, HHS said. Big tobacco companies, campaigners and others have called on the agency to focus enforcement on distributors and middlemen that fuel the market for unauthorised e-cigarettes from U.S. soil but have so far faced limited action from the FDA. Most of the illegal shipments originated in China and included vague product descriptions and incorrect valuations to evade duties and safety reviews, HHS said. "This enforcement action is part of the FDA's broader aggressive strategy against childhood vaping," HHS added. In total this year, the FDA and CBP have blocked over 6 million unauthorized e-cigarettes worth more than $120 million from entering the United States. Truth Initiative, a public health nonprofit group, said the actions were an important step in protecting youth but urged officials to "take further, sustained actions to cut off access to illegal e-cigarettes and ensure that retailers swiftly pull...

The U.S. Food and Drug Administration is tightening oversight of imports of GLP-1 drug ingredients, used for weight loss and diabetes, amid concerns that many of the items may be adulterated and pose a safety risk. The move comes as the FDA cracks down on unapproved compounded drugs, which had filled the gap during shortages of patented treatments. Soaring demand for Novo Nordisk (NOVOb.CO), opens new tab and Eli Lilly's (LLY.N), opens new tab obesity drugs has fueled a booming global market for cheaper, and sometimes even counterfeit versions. The health regulator said it had previously identified serious concerns with compounded weight-loss drugs, including dosing errors, use of unapproved salt forms and side effects, with some requiring hospitalization. As part of its heightened scrutiny, the FDA sent an import alert on Friday authorizing detention without physical examination (DWPE) at U.S. ports. This will allow the agency to seize shipments that appear to be non-compliant with federal requirements, without inspecting them on arrival. Importers must now provide proof of quality and compliance before their goods are released. The FDA evaluated 48 manufacturing sites outside the U.S. and found 21% of them as non-compliant. "What is clear is that the FDA is OK with continued compounding," Marta...

The U.S. Food and Drug Administration on Wednesday proposed a new process to streamline the approval of drugs targeting rare diseases with very small patient populations, including cases supported by data from single-arm clinical trials. The regulator said eligibility will be based on whether the disease affects a small population – fewer than 1,000 individuals in the United States – and is intended to treat a genetic defect. It will also depend on whether there are no adequate alternative therapies that alter the course of the disease. The agency added that it expects substantial evidence of effectiveness may generally be established based on one adequate study, which may be a single-arm trial. This will be supported by data that provides confirmatory evidence of the drug's treatment effect, which could be data on its action at the target site and pre-clinical data. FDA's proposal comes after Health Secretary Robert F. Kennedy Jr. said in June that the U.S. drugs regulator would look for ways to fast-track approval for rare disease treatments and remove obstacles to their path to market. The appointment of Vinay Prasad, the FDA's top vaccine and biologics official, as the head of the FDA's Center for Biologics Evaluation and Research had stoked fears...

Drug developers are increasing adoption of AI technologies for discovery and safety testing to get faster and cheaper results, in line with an FDA push to reduce animal testing in the near future. Within the next three to five years, using AI and cutting back on animal testing could reduce timelines and costs by at least half, according to 11 different experts from across contract research firms, biotech companies and brokerages. Drug development software maker Certara, and biotechs such as Schrodinger and Recursion Pharmaceuticals are already using AI to predict how experimental drugs might be absorbed, distributed, or trigger toxic side effects. "We are getting to the point where we don't actually need to do that (animal testing) anymore," said Patrick Smith, president of drug development solutions at Certara, which works with companies developing infectious diseases drugs such as monoclonal antibodies for hepatitis B. Recursion said its AI-based drug discovery platform took just 18 months to move a molecule into clinical testing as a cancer drug candidate, far faster than the industry average of 42 months. Analysts at TD Cowen and Jefferies expect these AI-driven approaches to cut costs and timelines by more than half, from current estimates of up to 15 years and...

The U.S. Food and Drug Administration on Wednesday proposed a new process to streamline the approval of drugs targeting rare diseases with very small patient populations, including cases supported by data from single-arm clinical trials. The regulator said eligibility will be based on whether the disease affects a small population – fewer than 1,000 individuals in the United States – and is intended to treat a genetic defect. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. It will also depend on whether there are no adequate alternative therapies that alter the course of the disease. The agency added that it expects substantial evidence of effectiveness may generally be established based on one adequate study, which may be a single-arm trial. This will be supported by data that provides confirmatory evidence of the drug's treatment effect, which could be data on its action at the target site and pre-clinical data. FDA's proposal comes after Health Secretary Robert F. Kennedy Jr. said in June that the U.S. drugs regulator would look for ways to fast-track approval for rare disease treatments and remove obstacles to their path to market. The appointment of Vinay Prasad, the FDA's top vaccine...