FDA Launches New AI Tool

The tool is being used in scientific evaluations and clinical reviews, according to the agency.

The U.S. Food and Drug Administration building in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The Food and Drug Administration on June 2 launched a new artificial intelligence (AI) tool.

FDA officials said Elsa, the tool, will help employees “work more efficiently.”

The agency is utilizing Elsa to speed up clinical protocol reviews and scientific evaluations, as well as to identify targets for inspections.

FDA officials described Elsa as a “large language model–powered AI tool designed to assist with reading, writing, and summarizing.” They said it can summarize adverse events to help with safety profile assessments, compare labels faster than humans, and generate code to help develop databases.

“Today marks the dawn of the AI era at the FDA with the release of Elsa, AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee,” FDA Chief AI Officer Jeremy Walsh said in a statement.

AI refers to computer systems that perform complex tasks typically performed by humans.

Dr. Marty Makary, the FDA’s commissioner, said in May that the FDA would immediately start using AI and fully integrate it by the end of June.

“Following a very successful pilot program with FDA’s scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,” Makary said on Monday. “Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”

Health Secretary Robert F. Kennedy Jr., who leads the Department of Health and Human Services (HHS), the FDA’s parent agency, cheered the development, calling it “a revolution in public health” in a post on social media platform X.

The FDA recently fired thousands of employees. HHS officials had said they would cut about 3,500 full-time workers but ended up terminating about 2,500 workers, according to a Senate Democrat report.

Makary told a congressional panel during a recent appearance that no scientific reviewers were fired, although some research scientists were among those terminated.

President Donald Trump has promoted the use of AI, saying in one order that “with the right Government policies, we can solidify our position as the global leader in AI and secure a brighter future for all Americans.”

The first report from Trump’s Make America Healthy Again (MAHA) Commission, headed by Kennedy, contained markers of AI, including nonexistent studies and multiple instances of “oaicite,” which developers say is inserted by OpenAI’s ChatGPT AI tool.

“The pattern is consistent with other cases we’ve seen of using generative AI to create citations,” Dr. Ivan Oransky, co-founder of Retraction Watch and executive director of The Center for Scientific Integrity, told The Epoch Times in an email.

“The fact that these fake citations made it into the report are evidence that no one checked the report for rigor. That should concern anyone who reads it or considers relying on it.”

The 73-page report was updated in late May to fix 58 errors, including 39 citation errors, according to an Epoch Times analysis.

When asked whether the commission used AI, the White House referred reporters to HHS, which declined to directly answer the question.

“Minor citation and formatting errors have been corrected, but the substance of the MAHA report remains the same—a historic and transformative assessment by the federal government to understand the chronic disease epidemic afflicting our nation’s children,” a spokesperson told The Epoch Times in an email.

Sylvia Xu contributed to this report.