The Food and Drug Administration (FDA) said it plans to launch a generative AI platform across all its centers by June 30, the agency said on May 8.
The FDA said the rollout will allow FDA scientists and subject-matter experts to spend less time on “tedious, repetitive tasks” that often slow down the review process.
“I was blown away by the success of our first AI-assisted scientific review pilot,” said FDA Commissioner Marty Makary. “We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process.”
The FDA oversees several centers, including the Center for Tobacco Products (CTP). The CTP is responsible for reviewing premarket tobacco product applications (PMTAs).
A U.S. Department of Health and Human Services (HHS) spokesperson said in a May 8 statement to CSP Daily News that the “FDA is committed to enhancing efficiency and consistency in scientific reviews and drug development to better serve the American public. Commissioner Makary has emphasized AI is a tool to support—not replace—human expertise. When used responsibly, AI can enhance regulatory rigor by helping predict toxicities and adverse events for certain conditions.”
The spokesperson added that “this initiative aims to reduce non-productive tasks, accelerate review timelines and empower scientists to focus on higher-value activities.”
David Spross, executive director of the National Association of Tobacco Outlets (NATO), a national retail trade association that represents more than 66,000 stores throughout the country, told CSP Daily News that despite not knowing all the details of how AI is going to be used in scientific review “NATO is intrigued about the possibility of the tool if it creates efficiencies and speeds up the PMTA review process, which is currently facing severe backlogs.”
On April 21, a group of Democratic senators, led by Jeff Merkley (D-Oregon), Richard Blumenthal (D-Connecticut), Dick Durbin (D-Illinois) and Edward J. Markey (D-Massachusetts) sent a letter to the HHS expressing concern over the FDA’s CTP cuts to its workforce.
“Dozens of staffers at the Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) have been placed on administrative leave, including the Center’s director, and the Center for Disease Control and Prevention’s (CDC) Office on Smoking and Health (OSH) has been gutted. These actions risk undermining progress that has been made in reducing the death, disease and addiction caused by tobacco use,” the senators wrote. “Without these critical staff, we are concerned that more youth will start using tobacco products, fewer people will quit and more people will become ill and die from tobacco-caused disease.”
The letter also asked for the Trump administration to “please indicate how CTP intends to spend its tobacco user fees for FY 2025, including, but not limited to, dollars spent on premarket review, enforcement of marketing and sales of illegal products, and Tobacco Centers of Regulatory Science.”
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