FDA Embraces AI to Accelerate Drug Approvals and Enhance Efficiency

F.D.A. Looks to A.I. to Enhance Efficiency

The Food and Drug Administration is planning to use artificial intelligence to "radically increase efficiency" in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA. Another initiative involves a review of chemicals and other "concerning ingredients" that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count. "The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust," Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article. The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration's efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly. Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device. "I don't want to be dismissive of speeding reviews at the F.D.A.," said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. "I think that there is great potential here, but I'm not seeing the beef yet." A major A.I. rollout closely follows the release of a report by Mr. Kennedy's MAHA Commission, which uses an acronym for Make America Healthy Again, that was found to be rife with references to scientific research apparently fabricated by an artificial intelligence program. For some cases, the F.D.A. officials proposed speeding major drug approvals by requiring only one major study in patients rather than two, a practice the agency has used in recent years. The pandemic provided a precedent, they said, for accelerating the process. "We believe this is clear demonstration that rapid or instant reviews are possible," Drs. Makary and Prasad wrote. But Mr. Holland pointed out that during the pandemic, many staff members were transferred from routine duties, including overseas inspections of food or drug facilities, and reassigned to hasten critical Covid product reviews. Trump Administration: Live Updates Updated June 10, 2025, 9:30 a.m. ET2 hours ago The global economy will slow sharply this year as Trump's trade war bites, the World Bank says. The clock ticks as the U.S. and China try to undo devastating trade curbs.In a challenge to Trump, the Smithsonian says it controls personnel decisions. The agency was also better staffed. In recent months, the F.D.A. shed about 1,940 employees, reducing the work force to 8,000 from roughly 10,000. Last week, the agency introduced Elsa, an artificial intelligence large-language model similar to ChatGPT. The F.D.A. said it could be used to prioritize which food or drug facilities to inspect, to describe side effects in drug safety summaries and to perform other basic product-review tasks. The F.D.A. officials wrote that A.I. held the promise to "radically increase efficiency" in examining as many as 500,000 pages submitted for approval decisions. Current and former health officials said the A.I. tool was helpful but far from transformative. For one, the model limits the number of characters that can be reviewed, meaning it is unable to do some rote data analysis tasks. Its results must be checked carefully, so far saving little time. Staff members said that the model was hallucinating, or producing false information. Employees can ask the Elsa model to summarize text or act as an expert in a particular field of medicine. Dr. Makary said the A.I. models were not being trained by data submitted by the drug or medical device industry. When it comes to food oversight, Drs. Makary and Prasad said there would be a renewed focus on "our increasingly chemically manipulated diet," a goal embraced by Republicans and Democrats. "For all additives," the article said, "the benefit-to-harm balance must be re-evaluated." Although the Trump administration is seeking steep cuts in the F.D.A.'s budget for the next fiscal year, the food division is expected to receive additional funds. Others noted the fine line agency officials were walking, given Mr. Kennedy's complaints that the F.D.A. is too close to the drug industry and the Trump administration's business-friendly approach. Drs. Makary and Prasad wrote that the F.D.A. must be "partners with industry" while avoiding "a cozy relationship that has characterized the agency in the past." Dr. Reshma Ramachandran, a director of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency, pointed out that Drs. Makary and Prasad were going on a six-city, closed-door listening tour to meet with chief executives of the drug industry. "How is this guarding the agency 'against a cozy relationship' with industry?" she asked. The F.D.A. priorities "read as though they're straight out of PhRMA's playbook," she said, referring to the trade group.

FDA plans to use AI to speed up drug and food safety reviews

The U.S. Food and Drug Administration (FDA) says it plans to use artificial intelligence (AI) to help speed the approval of new drugs and medical devices. That's one of several priorities federal officials detailed June 10 in JAMA. They said AI could help shorten review times, speeding delivery of treatments to people who need them. "The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust," Dr. Marty Makary, the FDA commissioner, and Dr. Vinay Prasad, who leads the agency's vaccine and gene therapy division, wrote in the viewpoint article. One new tool, named Elsa, is similar to ChatGPT and may help the FDA review safety data, summarize reports and flag which drug or food facilities need inspection, The New York Times reported. Right now, reviewing applications for new drugs can take months or years. Elsa may help process up to 500,000 pages of submitted data, the agency said. But there are limits. Some FDA staff said Elsa often gave wrong answers -- what experts call "hallucinations" -- and has to be double-checked. Others said the tool can't handle larger sets of data and doesn't save much time yet. Still, Makary and Prasad said the agency hopes to cut final approval steps down to a few weeks, similar to Operation Warp Speed during the COVID-19 pandemic. "We believe this is clear demonstration that rapid or instant reviews are possible," the doctors wrote. The FDA also plans to take a closer look at "concerning ingredients" used in U.S. foods that may not be allowed in other countries. "For all additives, the benefit-to-harm balance must be re-evaluated," the article said. This includes artificial food dyes and other chemicals found in many foods, The Times reported. Some experts are concerned about the FDA's plans. They include Stephen Holland, a former health adviser to Congress. He noted that during the pandemic, many FDA staffers were reassigned in order to speed up critical COVID reviews. "I think that there is great potential here," Holland said, "But I'm not seeing the beef yet." Others worry about the relationship between federal regulators and drug companies and its potential effect on future approvals. Dr. Reshma Ramachandran of Yale University noted that FDA leaders are now meeting with drug company CEOs behind closed doors in six cities, The Times said in a new report. "How is this guarding the agency 'against a cozy relationship' with industry?" Ramachandran asked. "The F.D.A. priorities read as though they're straight out of PhRMA's playbook," she told The Times, referring to the trade group. While the Trump administration is proposing big cuts to the FDA's overall budget, the food division may receive more funding to support the new efforts. The FDA has fewer workers now than during the pandemic. It recently lost about 1,940 staff, bringing its workforce down to 8,000. Even with these challenges, though, the agency still aims to help patients get treatments faster.

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.

FDA wants to use AI to speed up drug approval process

FDA officials want more AI in the review process. Credit: Tom Brenner/ The Washington Post via Getty Images The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal worker layoffs. The administration wants to "radically increase efficiency" using the burgeoning technology, according to a new article published in the Journal of the American Medical Association (JAMA) outlining the agency's priorities. The department's plan includes using artificial intelligence to examine device and drug applications, which would reportedly shave years off of the approval process, as well as AI computational modeling to reduce animal testing. The plan also proposes requiring just one major patient study to facilitate approvals, part of an overhaul of "legacy" processes. The article cites the success of COVID-19's Operation Warp Speed as precedent for diminished release timelines, but many professionals remain skeptical. "Rethinking our approach to AI, balancing safety and accuracy while fueling innovation, is a leading FDA priority... The FDA and our great medical profession should unite to consider fresh new approaches to the evolving health topics facing the US today." the report reads. "The FDA will take conflict of interest seriously." The article was authored by Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research (CBER), and Commissioner of Food and Drugs Martin A. Makary. Prasad and Makary have backed the department overhaul touted by U.S. Secretary of Health and Human Services Robert F. Kennedy, Jr. Kennedy has been on the offensive against the nation's scientists and physicians, labelling the FDA "a sock puppet of industry," clearing the Centers for Disease Control and Prevention (CDC)'s vaccine advisory committee, and pushing for a generative AI overhaul. In May, the FDA launched its first AI-assisted scientific review pilot, intended to "reduce the amount of non-productive busywork" for FDA scientists and subject matter experts, according to Makary. That same month, experts admonished a report by Kennedy's Make America Healthy Again initiative that was allegedly riddled with fake studies and incorrect citations possibly produced by artificial intelligence.

The FDA Is Already Outsourcing Drug and Food Analysis to Error-Plagued AI Chatbot

In case you haven't had enough about artificial intelligence, the US Food and Drug Administration is now outsourcing its oversight duties to a large language model (LLM.) In an article published in the Journal of the American Medical Association (JAMA), FDA bureaucrats Marty Makary and Vinay Prasad -- the latter of whom is a noted critic of COVID mask mandates and vaccine boosters -- laid out a five-point list of priorities that the federal agency is hoping to tackle. Among them is "unleashing AI" via a plan to use chatbots to "radically increase efficiency in the review process." This includes reviewing documents, drug applications "that often exceed 500,000 pages," and data formatting. This goes hand in hand with other priorities to "accelerate cures" by delivering "rapid or instant reviews" of drug products, and deliver "healthier food to children" by quickly approving "novel food dyes that use natural ingredients." On top of drugs, the FDA also wants to blow the lid off of AI reviews and medical device evaluation in order to "fuel innovation." That's a clever way to say "open the flood gates" for pharmaceutical superprofits, not coincidentally a major talking point for PhRMA, the drug industry's lobbying group. Probably conscious of this criticism, the article's coauthors specifically say they will "guard against a cozy relationship" with drug industry moguls. While this remains to be seen, the flipside under Health Secretary RFK Jr -- a notorious friend to the alternative medicine industry -- is hardly much better. Regardless, experts aren't impressed with the AI agenda. "How is this guarding the agency 'against a cozy relationship' with industry?" Dr. Reshma Ramachandran, director of a major research and policy initiative at Yale, asked the New York Times. The FDA's priorities "read as though they're straight out of PhRMA's playbook," she added. As far as the AI goes, the FDA had already been testing an "AI-assisted scientific review pilot" back on May 8, the JAMA article notes. Last week, that was revealed to be "Elsa," an LLM running on GovCloud, a platform developed by Amazon for the US intelligence community. Though evidence suggests LLM chatbots are becoming worse at summarizing scientific research as time goes on, the government has already been using Elsa to read reports, summarize unintended drug harms, compare product labels, and generate code. Whether or not Elsa was responsible for RFK Jr's "Make America Healthy Again" dossier, which cited AI-hallucinated studies, remains to be seen. Still, the sloppified report could be a harrowing glimpse of things to come as the agency looks to offload its critical oversight work to an untested chatbot. Elsa's rollout comes after over 2,000 of the FDA's 10,000 workers have been sent packing under the Trump administration. That process began first under Elon Musk's DOGE, where device inspectors responsible for regulating his Neuralink device were axed. Musk's moves were followed by broader cuts under RFK Jr, who recently ousted the CDC's entire panel of vaccine advisors before installing his own vaccine-skeptic picks.

FDA to use AI in drug approvals to 'radically increase efficiency'

The Food and Drug Administration is planning to use artificial intelligence to "radically increase efficiency" in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA. Another initiative involves a review of chemicals and other "concerning ingredients" that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the COVID-19 pandemic, when workers raced to curb a spiraling death count. "The FDA will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust," Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article. The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration's efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly. Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that AI is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device. "I don't want to be dismissive of speeding reviews at the FDA," said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. "I think that there is great potential here, but I'm not seeing the beef yet." A major AI rollout closely follows the release of a report by Kennedy's MAHA Commission, which uses an acronym for Make America Healthy Again, that was found to be rife with references to scientific research apparently fabricated by an AI program. For some cases, the FDA officials proposed speeding major drug approvals by requiring only one major study in patients rather than two, a practice the agency has used in recent years. The pandemic provided a precedent, they said, for accelerating the process. "We believe this is clear demonstration that rapid or instant reviews are possible," Makary and Prasad wrote. But Holland pointed out that during the pandemic, many staff members were transferred from routine duties, including overseas inspections of food or drug facilities, and reassigned to hasten critical COVID product reviews. The agency was also better staffed. In recent months, the FDA shed about 1,940 employees, reducing the workforce to 8,000 from roughly 10,000. Last week, the agency introduced Elsa, an AI large-language model similar to ChatGPT. The FDA said it could be used to prioritize which food or drug facilities to inspect, to describe side effects in drug safety summaries and to perform other basic product-review tasks. The FDA officials wrote that AI held the promise to "radically increase efficiency" in examining as many as 500,000 pages submitted for approval decisions. Current and former health officials said the AI tool was helpful but far from transformative. For one, the model limits the number of characters that can be reviewed, meaning it is unable to do some rote data analysis tasks. Its results must be checked carefully, so far saving little time. Staff members said the model was hallucinating, or producing false information. Employees can ask the Elsa model to summarize text or act as an expert in a particular field of medicine. Makary said the AI models were not being trained by data submitted by the drug or medical device industry. When it comes to food oversight, Makary and Prasad said there would be a renewed focus on "our increasingly chemically manipulated diet," a goal embraced by Republicans and Democrats. "For all additives," the article said, "the benefit-to-harm balance must be reevaluated." Although the Trump administration is seeking steep cuts in the FDA's budget for the next fiscal year, the food division is expected to receive additional funds. Others noted the fine line agency officials were walking, given Kennedy's complaints that the FDA is too close to the drug industry and the Trump administration's business-friendly approach. Makary and Prasad wrote that the FDA must be "partners with industry" while avoiding "a cozy relationship that has characterized the agency in the past." Dr. Reshma Ramachandran, a director of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency, pointed out that Makary and Prasad were going on a six-city, closed-door listening tour to meet with chief executives of the drug industry. "How is this guarding the agency 'against a cozy relationship' with industry?" she asked. The FDA priorities "read as though they're straight out of PhRMA's playbook," she said, referring to the trade group.

FDA Plans to Use AI to Speed Up Drug and Food Safety Reviews

WEDNESDAY, June 11, 2025 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) says it plans to use artificial intelligence (AI) to help speed the approval of new drugs and medical devices. That's one of several priorities federal officials detailed June 10 in JAMA. They said AI could help shorten review times, speeding delivery of treatments to people who need them. "The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust," Dr. Marty Makary, the FDA commissioner, and Dr. Vinay Prasad, who leads the agency's vaccine and gene therapy division, wrote in the viewpoint article. One new tool, named Elsa, is similar to ChatGPT and may help the FDA review safety data, summarize reports and flag which drug or food facilities need inspection, The New York Times reported. Right now, reviewing applications for new drugs can take months or years. Elsa may help process up to 500,000 pages of submitted data, the agency said. But there are limits. Some FDA staff said Elsa often gave wrong answers -- what experts call "hallucinations" -- and has to be double-checked. Others said the tool can't handle larger sets of data and doesn't save much time yet. Still, Makary and Prasad said the agency hopes to cut final approval steps down to a few weeks, similar to Operation Warp Speed during the COVID-19 pandemic. "We believe this is clear demonstration that rapid or instant reviews are possible," the doctors wrote. The FDA also plans to take a closer look at "concerning ingredients" used in U.S. foods that may not be allowed in other countries. "For all additives, the benefit-to-harm balance must be re-evaluated." the article said. They include Stephen Holland, a former health adviser to Congress. He noted that during the pandemic, many FDA staffers were reassigned in order to speed up critical COVID reviews. "I think that there is great potential here," Holland said, "But I'm not seeing the beef yet." Others worry about the relationship between federal regulators and drug companies and its potential effect on future approvals. Dr. Reshma Ramachandran of Yale University noted that FDA leaders are now meeting with drug company CEOs behind closed doors in six cities, The Times said in a new report. "How is this guarding the agency 'against a cozy relationship' with industry?" Ramachandran asked. "The F.D.A. priorities read as though they're straight out of PhRMA's playbook," she told The Times, referring to the trade group. While the Trump administration is proposing big cuts to the FDA's overall budget, the food division may receive more funding to support the new efforts. The FDA has fewer workers now than during the pandemic. It recently lost about 1,940 staff, bringing its workforce down to 8,000. Even with these challenges, though, the agency still aims to help patients get treatments faster. More information The U.S. Food and Drug Administration has more on its development and approval process.