The FDA is embracing AI boldly. Now it must show what responsible innovation looks like
作者：Jennifer Goldsack
May 16, 2025
Goldsack is the founder and chief executive officer of the Digital Medicine Society (DiMe).
In an industry known for its caution, the Food and Drug Administration’s decision to rapidly deploy generative AI across all medical product review offices by the end of June is a rare and seismic move. It’s bold. It’s ambitious. And if implemented well, it could mark the beginning of a desperately needed transformation in how we bring trustworthy innovation to the regulation of medical product development.
Medical product development is not just expensive and slow, it’s broken. Fewer than 10% of drug candidates succeed. It can take over a decade and billions of dollars to bring a single therapy to market. Devices fare slightly better, but even then, years of effort can end in silence.
Now, add the pressure of looming patent cliffs, the threat of price negotiations, and renewed pushes for “most-favored nation” drug pricing policies through the executive order President Trump has signed, which would peg U.S. prices to those paid in the lowest-cost countries. Whether or not such efforts succeed in court this time, the message is clear: Business as usual will no longer be protected.
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