WASHINGTON — Sanofi has formally asked the U.S. Food and Drug Administration (FDA) to withdraw its type 1 diabetes drug, teplizumab, from Commissioner Marty Makary’s newly launched expedited drug review program.
The request comes amid a reported disagreement between acting Center for Drug Evaluation and Research (CDER) director Tracy Beth Høeg and FDA staff over the drug’s approval. Sources familiar with the dispute, who spoke on condition of anonymity due to fear of retaliation, confirmed that Høeg, a political appointee, challenged the staff’s recommendation to approve teplizumab.
Typically, such scientific decisions are made by career scientists. Involvement from a center director—especially a political appointee—is highly unusual, particularly in the review of a single drug.
Makary recently told CNBC that he supports review teams and warned that “disaster” occurs when political leaders override scientific staff.
The FDA also missed its April 21, 2024 goal date to issue a decision on teplizumab’s approval.
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