Introduction to Elsa: The FDA’s New AI Tool

The US Food and Drug Administration (FDA) has introduced a new artificial intelligence (AI) tool called Elsa, which is designed to help the agency with its administrative tasks. However, some FDA staffers have expressed concerns about the tool, saying it was "rushed" and its capabilities were overinflated by officials.

What is Elsa and How Does it Work?

Elsa is based on Anthropic’s Claude LLM and is being developed by consulting firm Deloitte. The tool is being developed to help the FDA with its administrative tasks, such as accessing internal documents and answering questions. Since 2020, Deloitte has been paid $13.8 million to develop the original database of FDA documents that Elsa’s training data is derived from. In April, the firm was awarded a $14.7 million contract to scale the tech across the agency.

Concerns About Elsa

FDA staffers who spoke with Stat news called the tool "rushed" and said its capabilities were overinflated by officials, including Makary and those at the Department of Government Efficiency (DOGE), which was headed by controversial billionaire Elon Musk. The staffers said that the tool should only be used for administrative tasks, not scientific ones, and that the FDA has failed to set up guardrails for its use. "Makary and DOGE think AI can replace staff and cut review times, but it decidedly cannot," one employee said.

Problems with Other AI Pilots

Previously, each center within the FDA was working on its own AI pilot. However, after cost-cutting in May, the AI pilot originally developed by the FDA’s Center for Drug Evaluation and Research, called CDER-GPT, was selected to be scaled up to an FDA-wide version and rebranded as Elsa. FDA staffers in the Center for Devices and Radiological Health told NBC News that their AI pilot, CDRH-GPT, is buggy, isn’t connected to the Internet or the FDA’s internal system, and has problems uploading documents and allowing users to submit questions.

Conclusion

The introduction of Elsa, the FDA’s new AI tool, has raised concerns among FDA staffers about its capabilities and use. While the tool is designed to help with administrative tasks, some staffers believe it was "rushed" and its capabilities were overinflated by officials. The FDA needs to address these concerns and ensure that the tool is used effectively and safely.

FAQs

Q: What is Elsa and what is it used for?
A: Elsa is an AI tool developed by the FDA to help with administrative tasks, such as accessing internal documents and answering questions.
Q: Who developed Elsa?
A: Elsa was developed by consulting firm Deloitte, which has been paid $13.8 million to develop the original database of FDA documents that Elsa’s training data is derived from.
Q: What are the concerns about Elsa?
A: FDA staffers have expressed concerns that the tool was "rushed" and its capabilities were overinflated by officials, and that it should only be used for administrative tasks, not scientific ones.
Q: What other AI pilots has the FDA developed?
A: The FDA has developed other AI pilots, including CDER-GPT and CDRH-GPT, but these have been reported to be buggy and have problems uploading documents and allowing users to submit questions.