The US 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, according to Dr Marty Makary, the agency commissioner, and Dr Vinay Prasad, who leads the division that oversees vaccines and gene therapy.
Outlining their new plans in JAMA Network, they said another initiative involves a review of chemicals and other “concerning ingredients” found in American food – but not in the food of other developed nations. And officials want to escalate the final stages of drug or medical device approval decisions to mere weeks, they said, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiralling death count.
“The FFA 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,” they wrote.
The new road map is part of 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, reports The New York Times.
However, some aspects of the proposals were greeted with scepticism, 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 FDA,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on healthcare. “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 Health Secretary Robert F Kennedy Jr’s MAHA Commission (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 FDA officials proposed accelerating 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 speeding up 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 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 has shed nearly 2 000 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 FDA said it could be used to prioritise which food or drug facilities to inspect, to describe side effects in drug safety summaries, and to perform other basic product-review tasks.
The 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 said that the model was hallucinating, or producing false information. Employees can ask the Elsa model to summarise 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”.
“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 FDA’s budget for the next fiscal year, the food division is expected to receive additional funds.
Makary and Prasad wrote that the FDA must be “partners with industry” while avoiding “a cosy relationship that has characterised the agency in the past”.
Dr Reshma Ramachandran, a director of the Yale Collaboration for Regulatory Rigour, Integrity and Transparency, pointed out that Makary and Prasad were going on a six-city, closed-door listening tour to meet chief executives of the drug industry.
“How is this guarding the agency ‘against a cosy relationship’ with industry?” she asked.
See more from MedicalBrief archives:
RFK Jr moves to ban artificial dyes in food
Top FDA boss resigns over RFK Jr’s ‘misinformation’
RFK Jr threatens to ban scientists from publishing in top journals