Sanofi pulls teplizumab from FDA fast-track program after political appointee Høeg allegedly blocked staff approval

Sanofi has requested the removal of its type 1 diabetes drug teplizumab from Commissioner Marty Makary's expedited review initiative, according to sources familiar with the matter. The request follows an internal dispute at the Food and Drug Administration in which acting Center for Drug Evaluation and Research director Tracy Beth Høeg reportedly challenged a staff-level recommendation to approve the medication. The agency has failed to meet its self-imposed April 21 decision deadline, leaving Sanofi's application in limbo.

Sources indicate the disagreement represents an unusual breach in standard procedure. Decisions of this nature typically rest with career scientists operating through established review channels. The involvement of a political appointee in evaluating a single drug's scientific merits has raised concerns about institutional independence. Høeg's appointment as acting CDER director places her among the senior political leadership at the agency, making her direct engagement in a specific drug review highly irregular.

Makary recently defended scientific autonomy in public comments, asserting that disaster follows whenever political leaders override staff recommendations. Yet the teplizumab case suggests pressure may be flowing in the opposite direction, with a political appointee overriding career staff judgment. Sanofi has not publicly commented on the withdrawal request. The delayed decision compounds uncertainty for patients awaiting access to the therapy, which had been expected to receive approval under Makary's program designed to accelerate access to novel treatments.