With Elsa, a Hyper Efficient AI Tool, the FDA Steps Boldly into the Future

By Jennifer Galardi, Contributor, The MAHA Report; and Staff

The U.S. Food and Drug Administration (FDA), long accused of dragging its feet during the approval process for all manner of drugs and research, earlier this week signaled that it’s changing its ways.

The FDA has launched a new generative AI tool that it says will enhance the efficiency of its employees, including scientific reviewers and field investigators.

In a video released on YouTube, featuring a upbeat, male AI-generated voice, we learn that Elsa is designed to “optimize operations and enhance performance for its employees.”

Further, we’re told: “This groundbreaking initiative promises to modernize how the agency serves the American public by leveraging cutting-edge technology. Elsa is built within a high-security GovCloud environment, ensuring sensitive data remains protected and internal to the FDA.”

Moreover, we hear: “Unlike other AI tools, Elsa doesn't train on data from regulated industries, safeguarding the integrity of research and evaluations. The tool is designed to assist with tasks like summarizing adverse events, accelerating clinical protocol reviews, and even generating code for database development. The rollout of ELSA marks the beginning of the FDA's broader AI journey, with plans to expand its use across various processes.”

In its press release about Elsa, the FDA further states, “The application, implemented ahead of schedule and under budget after a successful pilot program, has reduced some review tasks from days to minutes, according to some employees.”

Agency staff members have been using Elsa to summarize adverse events to support safety profile assessments; conduct expedited label comparisons; and generate code to facilitate the development of databases for non-clinical application.

While some FDA employees have expressed concerns that the tool was “rushed” and its capabilities may be overstated, FDA Chief AI Officer Jeremy Walsh pushed back and praised the technology.

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

Continued Walsh, “As we learn how employees are using the tool, our development team will be able to add capabilities and grow with the needs of employees and the agency.”

In an official video announcement, FDA head Marty Makary put privacy and security concerns to rest. “I want to be clear,” he said. “All information stays within the agency and the AI models are not being trained on data submitted by the industry.”

He also promised future updates to agency functions using AI.

Beyond Elsa, the FDA under Makary, like the Department of Health and Human Services under Robert F. Kennedy Jr., has been generating news through bold decision making and radical transparency – qualities that bear little resemblance to earlier iterations of these agencies.

On June 1, for example, Makary confronted CBS’s “Face the Nation” host Margaret Brennan about the new Covid-19 mRNA recommendations.

Makary emphasized that pregnant women, in coordination with their doctor, are responsible for the decision of whether or not to get Covid-19 jabs.

This is a departure from the previous administration’s guidelines that were devised without significant data to support requiring pregnant women to take the shot. As Makary explained to Brennan, “a randomized control trial was set up and it was closed without any explanation.”

Makary also made clear the FDA is going to continue pursuing a different approach when it comes to agency recommendations, particularly for healthy individuals.

“We’re going to get away from these blanket recommendations in healthy young Americans,” Makary told Brennan. “We don’t want to see kids kicked out of school because a 12-year old girl is not getting her fifth Covid booster shot.”

Makary continued, “we don't see the data there to support a young healthy child getting a repeat, infinite, annual, Covid vaccine.” Repeat boosters, he said, is merely a “theory.”