STAT+: Sanofi asks to pull diabetes drug out of FDA voucher program after political appointee interfered with review

STAT PlusExclusive Sanofi asks to pull diabetes drug out of FDA voucher program after political appointee interfered with review CDER head Tracy Beth Høeg disagreed with staff approval decision, sources say Manage alerts for this article Email this article Share this article By Lizzy LawrenceMay 6, 2026 FDA Reporter Lizzy Lawrence[email protected]Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — Sanofi has asked the Food and Drug Administration to pull its type 1 diabetes drug, teplizumab, out of Commissioner Marty Makary’s new speedy drug review program. The move comes after acting Center for Drug Evaluation and Research Director Tracy Beth Høeg disagreed with a staff decision to approve the drug, according to sources familiar with the dispute who requested anonymity due to fear of reprisal. The agency has missed its goal date of April 21 to deliver a decision to Sanofi.Advertisement Such decisions are typically made by career scientists. It’s rare for a center director to become involved in scientific review of a single drug, and particularly a political appointee like Høeg. Makary recently told CNBC that he stands behind review teams, and that “disaster” occurs whenever political leaders overrule scientific staff. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. 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 diabetes, FDA, Sanofi, STAT+ Submit a correction requestReprints Lizzy Lawrence FDA Reporter Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Newsletter The latest updates in federal health agencies, research institutes, and U.S. policy Recommended Health April 30, 2026 Trump drops Casey Means as surgeon general nominee, opts for radiologist Nicole Saphier Business April 30, 2026 STAT Plus: Cigna will exit ACA individual markets next year, adding to tumult for patients Advertisement Biotech April 28, 2026 STAT Plus: FDA launches effort to speed up clinical trials, using AI Biotech April 28, 2026 Fauci adviser David Morens indicted on charges of concealing emails, avoiding records requests Biotech April 24, 2026 STAT Plus: FDA to speed up review of three psychedelics as mental health treatments Subscriber Picks