Sanofi requests removal of teplizumab from FDA fast-track voucher program after director dispute

Sanofi has formally asked the Food and Drug Administration to withdraw its type 1 diabetes therapy, teplizumab, from the new speedy review voucher program overseen by Commissioner Marty Makary.

The request follows a disagreement between acting CDER director Tracy Beth Høeg, a political appointee, and FDA staff who had recommended approval of the drug. Sources say Høeg intervened after the staff decision, prompting Sanofi to seek removal from the program.

Such direct involvement by a center director in a single drug’s scientific review is unusual and highlights tension between career scientists and political leadership within the agency. The move could affect the timeline for teplizumab’s market entry and underscores broader concerns about political influence on regulatory processes.