Latest news with #FoodAndDrugAdministration
Washington Post
a day ago
- Health
- Washington Post
How we plan to cut FDA drug approval time by months
Marty Makary is the commissioner of the Food and Drug Administration. For more than a century, the U.S. Food and Drug Administration has been a global leader in advancing medical cures, but in recent years, its regulatory framework has become an obstacle to innovation. Cumbersome requirements, poor communication and regulatory creep have made the United States less competitive in the global race for new drugs and treatments. Meanwhile, countries such as Australia and China, with more streamlined regulations, have become go-to destinations for clinical trials and early drug testing. The shift poses a risk not just to U.S. competitiveness but also to national security. To address it, the FDA must modernize. That's why I have just announced a pilot program that can slash the FDA's drug review time from 10 to 12 months to just one to two months. The program will make use of the idle time during clinical trials — time needed to see how the drug in question performs. Instead of submitting all the data at the end of a trial, qualifying manufacturers will be able to submit most elements of the application — including manufacturing details and drug labeling — while the trial is underway. The FDA will be able to review the early data and resolve any issues with the manufacturer at that time. Once the trial concludes, final data will be submitted. Then there will be about one month of FDA review, followed by a focused, one-day meeting with FDA scientists to reach a decision. This split-submission approach is entirely feasible — as shown by its success during Operation Warp Speed at the start of the covid-19 pandemic. This novel program tackles a common pain point voiced during my national listening tour: inaccessibility of FDA reviewers for clarifying questions. Pharmaceutical CEOs repeatedly told me a simple 15-minute call with their reviewer could save months of wasted work. Our new program adopts a real-time communication model, eliminating guesswork. No more mind-reading; drug developers will get straight answers when they're needed. As a surgical oncologist, I've experienced firsthand the benefits of team-based decision-making as a participant in 'tumor board' meetings where specialists collaborate to make critical decisions. A similar team approach can be applied at the FDA to evaluate the safety and efficacy of new drugs. In my first 12 weeks leading the FDA, we've made significant strides toward modernizing the agency. One example is the launch of Elsa, a tool powered by artificial intelligence that helps FDA reviewers sift through thousands of pages of data in minutes, instead of days. This tool is already being used by thousands of FDA staff daily, enabling them to focus more on what matters most: scientific expertise. Elsa doesn't replace human judgment but accelerates the review process, making the FDA more efficient and responsive. We're also speeding up approvals by phasing out outdated animal testing, replacing it with cutting-edge tools such as computational modeling and organ-on-a-chip toxicity testing, where a miniaturized, three-dimensional tissue mimics human function. These techniques are faster, cheaper and better at predicting human toxicity. Notably, about 90 percent of drugs that pass animal studies fail in humans. The FDA has even required animal studies on drugs already approved in Europe. We need both gold-standard science and common sense. Newer methods can be more predictive and humane. For drug developers, time is money. A previous valuable priority review program for rare pediatric diseases shortened FDA review time from 10 to 12 months to six. The market value of the six-month review was approximately $100 million to the pharmaceutical companies, showing that faster approval processes can be highly valuable. A one-month review process could be significantly more valuable and could incentivize companies to act on national priorities. These could include boosting domestic manufacturing for national security, addressing unmet public health needs or developing products for pandemic preparedness. The new national priority review program is designed to align speed, science and strategy. It rewards companies working on innovative solutions to real challenges faced by the American public, without sacrificing safety or the FDA's rigorous standards. By modernizing the FDA, we can ensure that the future of medicine is written in the United States. .
Washington Post
4 days ago
- Business
- Washington Post
Food giant Kraft Heinz vows to stop using artificial dyes
Kraft Heinz promised Tuesday to purge certain artificial food dyes from its products by the end of 2027, a move that follows pressure from the Food and Drug Administration over the issue. The company said it will replace food, drug and cosmetic (FD&C) dyes with natural versions when possible; create new colors and shades, if necessary; or simply remove colors in some cases.
Gizmodo
11-06-2025
- Health
- Gizmodo
After Slashing Thousands of Jobs, Trump's FDA Wants to Use AI to Rapidly Approve New Drugs
AI is slowly permeating all corners of the federal government, including the Food and Drug Administration, where, according to a newly released paper, its top brass now wants to use automation to more 'efficiently' approve new drugs. An article recently published in the Journal of the American Medical Association (JAMA) by Dr. Vinay Prasad, the FDA's director of a subagency that deals with vaccines, lays out a vision for revamping the agency that will supposedly 'increase efficiency' at the agency that regulates what you eat and drink. According to that article, a big way to make the agency more efficient is to use AI to do tasks that humans previously worked on. Specifically, it suggests using automation to speed up the drug approval process. 'The advent of generative artificial intelligence (AI) holds several promises to modernize the FDA and radically increase efficiency in the review process,' the paper reads, while noting that the agency has already implemented a pilot program that involves first 'AI-assisted scientific review.' The article also speaks of a need to 'reevaluate legacy processes at the agency that slow down decisions and do not increase safety.' The study also claims it is looking to find ways to use technology to avoid 'animal cruelty' at the agency. It has supposedly done this by developing 'a road map to reduce animal testing using AI-based computational modeling to predict toxicity-leveraging chip technology.' All of this news comes not long after the FDA purged thousands of staffers from its ranks, including those responsible for reviewing food safety. Now, in what has become a typical pivot for organizations looking to integrate AI, roles previously held by humans seem like they're being automated. The article also suggests the use of 'big data' to help better assess how drug products are developed and reviewed. 'In the past, randomized clinical trials were the sole method used to determine if a product was safe and effective,' the article reads. 'Advances in causal inference in nonrandomized data, including the use of target trials, which attempt to balance confounding and time zero, have [the] potential to yield actionable causal conclusions, in many cases at lower cost.' AI has been spread throughout other parts of the government, as the administration's supposed 'efficiency' mandate looks for newfangled methods to 'streamline' bureaucratic processes. If AI could technically help speed up some bureaucratic processes, a quick look at the way automation rollout is being handled at other agencies doesn't necessarily inspire confidence in the initiative, particularly when it comes to an agency tasked with overseeing drugs that go into Americans' bodies. When it comes to new drugs, there are always guinea pigs involved in the process; now AI's impact will have to be factored into the effectiveness of the latest tests.
CNA
02-06-2025
- Business
- CNA
US FDA launches AI tool to reduce time taken for scientific reviews
The U.S. Food and Drug Administration said on Monday that it had launched a generative AI tool, Elsa, aimed at improving efficiency across its operations, including scientific reviews. "Today's rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers," said FDA Commissioner Marty Makary. The agency said it is already using Elsa to expedite clinical protocol reviews, shorten the time needed for scientific evaluations, and pinpoint high-priority inspection targets. Once the FDA receives an application for a potential drug approval, it has six to 10 months to make a decision. Elsa assists with reading, writing, and summarizing tasks. It can summarize adverse events to support safety profile assessments of drugs and rapidly compare packaging inserts. "Elsa offers a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency. The models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff," the FDA said. In May, the regulator said it would fully integrate AI by June 30, following an experimental run.
Reuters
02-06-2025
- Business
- Reuters
US FDA launches AI tool to reduce time taken for scientific reviews
June 2 (Reuters) - The U.S. Food and Drug Administration said on Monday that it had launched a generative AI tool, Elsa, aimed at improving efficiency across its operations, including scientific reviews. "Today's rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers," said FDA Commissioner Marty Makary. The agency said it is already using Elsa to expedite clinical protocol reviews, shorten the time needed for scientific evaluations, and pinpoint high-priority inspection targets. Once the FDA receives an application for a potential drug approval, it has six to 10 months to make a decision. Elsa assists with reading, writing, and summarizing tasks. It can summarize adverse events to support safety profile assessments of drugs and rapidly compare packaging inserts. "Elsa offers a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency. The models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff," the FDA said. In May, the regulator said it would fully integrate AI by June 30, following an experimental run.
