Ex-FDA AI Chief: Biopharma Misreading Agency Guidance
Get the Health newsletter
Daily health & science — research, biotech, public health, the studies worth knowing. Free.
- Tala Fakhouri wrote AI policy at the FDA two years ago and now serves as chief AI and regulatory strategy officer at Parexel, a contract research organization.
- Fakhouri left the FDA last summer, giving her a firsthand view of how industry implements the guidance she helped draft.
- She said at a San Diego appearance that the FDA's intent to be flexible with AI guidance is "getting lost in translation."
- Fakhouri observed that biopharma is interpreting the agency's guidance in the most conservative way possible in order to avoid risk.
- She added that what she sees from inside the industry distresses her as it conflicts with the flexibility the agency intended.
Why it matters: A former FDA AI regulator now working inside a major CRO is publicly flagging that biopharma's risk-averse reading of the agency's flexible AI guidance goes beyond what the FDA intended — meaning companies may be self-imposing compliance constraints the agency never asked for.
