FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

To hear health officials in the Trump administration talk, artificial intelligence has arrived in Washington to fast-track new life-saving drugs to market, streamline work at the vast, multibillion-dollar health agencies, and be a key assistant in the quest to slash wasteful government spending without jeopardizing their work. “The AI revolution has arrived,” Health and Human Services Secretary Robert F. Kennedy Jr. has declared at congressional hearings in the past few months. “We are using this technology already at HHS to manage health care data, perfectly securely, and to increase the speed of drug approvals,” he told the House Energy and Commerce Committee in June. The enthusiasm — among some, at least — was palpable. Weeks earlier, the US Food and Drug Administration, the division of HHS that oversees vast portions of the American pharmaceutical and food system, had unveiled Elsa, an artificial intelligence tool intended to dramatically speed up drug and medical device approvals. Yet behind the scenes, the agency’s slick AI project has been greeted with a shrug — or outright alarm. Six current and former FDA officials who spoke on the condition of anonymity to discuss sensitive internal work told CNN that Elsa can be useful for generating meeting notes and summaries, or email and communique templates.