STAT+: A former AI regulator, now in industry, says biopharma is reading FDA’s guidance wrong

STAT PlusHealth tech A former AI regulator, now in industry, says biopharma is reading FDA’s guidance wrong Tala Fakhouri blames both companies and the FDA for creating unnecessary hurdles Manage alerts for this article Email this article Share this article By Brittany TrangJuly 2, 2026 Health Tech Reporter Brittany Trang[email protected]Brittany Trang, Ph.D., covers AI in health and medicine: Does it actually work? Who benefits, or might be harmed? She writes the weekly AI Prognosis newsletter. Follow her on Threads, Mastodon, and Bluesky. You can reach Brittany on Signal at btrang.01. SAN DIEGO — Two years ago, Tala Fakhouri was writing AI policy at the Food and Drug Administration. Now, after leaving the FDA last summer, she’s getting a firsthand look at how the industry is implementing the policies she wrote as chief AI and regulatory strategy officer at Parexel, a contract research organization. Advertisement What she sees distresses her. The FDA’s intent to be flexible is getting lost in translation, she said, and she’s seeing the industry interpreting that guidance in the most conservative way possible in order to avoid risk. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In Artificial intelligence, biotechnology, drug development, FDA, health tech, Pharmaceuticals, Policy, STAT+ Submit a correction requestReprints Brittany Trang Health Tech Reporter Brittany Trang, Ph.D., covers AI in health and medicine: Does it actually work? Who benefits, or might be harmed? She writes the weekly AI Prognosis newsletter. Follow her on Threads, Mastodon, and Bluesky. You can reach Brittany on Signal at btrang.01. STAT+ Newsletter A hitchhiker's guide to the health care AI galaxy Recommended Biotech July 2, 2026 STAT Plus: A year after distressed buyout, what’s become of Bluebird Bio? In the Lab July 1, 2026 STAT Plus: Synthetic biology researchers think they’ve made a cell. Is it alive? Advertisement The Readout July 1, 2026 STAT Plus: More signs that GLP-1s may help with peripheral artery disease Biotech July 1, 2026 STAT Plus: FDA approves Orca Bio’s T cell therapy for blood cancer patients Biotech July 1, 2026 STAT Plus: The biotech scorecard for the third quarter: 15 stock-moving events to watch Subscriber Picks