The news: The FDA is rolling out generative AI (genAI) for drug reviewers with agencywide use set for the end of June. FDA commissioner Dr. Marty Makary attributed the quick rollout to the recent success of an AI pilot for scientific reviewers.
Driving the news: The new genAI review help comes amid industry predictions that massive layoffs at the FDA—3,500 employees in April—will slow down the agency’s review and approval of new prescription drugs.
- Makary insisted the FDA laid off administrative and support staff only, not drug reviewers.
- However, reviewers said their jobs became more difficult after cuts to library resources, policy staff and IT workers, and predicted slower drug reviews as a result, per Bloomberg Law.
- The FDA has approved 11 drugs so far this year, trailing the average 16 approved by the same time from 2021-2024.
Yes, and: The FDA missed several drug decision deadlines recently, including for Novavax’s COVID-19 vaccine and Stealth BioTherapeutics' rare disease treatment for Barth Syndrome. The deadlines for FDA decisions, called PDUFA (Prescription Drug User Fee Act) dates, are set typically for six or 10 months after application filing, and drugmakers have counted on that predictability.
Why it matters: While the FDA touts significant time savings from AI-assisted drug reviews, genAI issues like hallucinations and data bias are tempering enthusiasm among experts, per Axios. If AI makes math mistakes or incorporates bias as fact, it could end up adding to human reviewers’ workload.
The takeaway: Pharma companies would welcome quicker drug approvals, but AI-assisted reviews aren’t a silver bullet.
Too many data issues and too little time to fine-tune the new process may only amplify pharma and biotech companies’ angst amid already delayed reviews. In the near term, manufacturers should closely monitor updates and developments related to how the regulator’s AI rollout is progressing.
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