Ex-FDA AI Official: Biopharma Misreads Agency Guidance
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- Tala Fakhouri spent two years writing AI policy at the FDA before leaving the agency last summer and moving to the private sector.
- Parexel, a contract research organization that supports drug development, hired Fakhouri as chief AI and regulatory strategy officer, giving her a window into how multiple biopharma clients implement the guidance.
- Fakhouri says the FDA's intent to be flexible in its AI guidance is getting lost in translation as drug companies put the policies into practice.
- Biopharma companies are interpreting the FDA's AI guidance in the most conservative way possible in order to avoid risk, according to Fakhouri.
- Fakhouri is watching from inside the industry as her former agency's policies are applied — a vantage point that lets her compare the FDA's stated intent to companies' actual implementations.
Why it matters: Fakhouri authored the rules at FDA and now watches them land at a CRO serving multiple biopharma clients, giving her direct evidence that companies are choosing the most risk-averse reading — eroding the flexibility regulators built into the framework before any drug submission is even filed.
