FDA Seeks AI Tool ‘Elsa’ for Enhanced Drug Safety Review

The FDA, previously known for rigorously evaluating drugs and medical devices, has begun outsourcing significant portions of its work to an AI called Elsa, developed on Amazon’s GovCloud. During the Trump administration, this shift raised concerns among experts, particularly after FDA officials Marty Makary and Vinay Prasad proposed a five-point plan to utilize AI for tasks like summarizing drug applications and approving novel food dyes. Critics, including Dr. Reshma Ramachandran from Yale, argue that this move aligns too closely with the interests of Big Pharma, undermining the FDA’s role in protecting public health. The agency, which has already cut its workforce by 2,000, now relies on AI in an uncertain future. Skepticism is amplified by the flawed “Make America Healthy Again” report, which allegedly contained references to nonexistent studies—a common pitfall of generative AI. Overall, this development raises significant questions about the integrity of drug approval processes.

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