• Posted June 11, 2025

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.

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.

More information

The U.S. Food and Drug Administration has more on its development and approval process.

SOURCE: The New York Times, June 10, 2025