Sanofi Withdraws Diabetes Drug from FDA's Expedited Review Program After Political Interference

Sanofi withdrew teplizumab, a type 1 diabetes drug, from FDA Commissioner Marty Makary's speedy drug review voucher program after political appointee Tracy Beth Høeg, acting Center for Drug Evaluation and Research Director, disagreed with staff's approval decision. The FDA missed its April 21 goal date for a decision. Political appointees rarely intervene in scientific reviews of individual drugs at the FDA, where career scientists typically make approval decisions.

Teplizumab FDA withdrawal

• ▪The Food and Drug Administration missed its goal date of April 21 to deliver a decision to Sanofi on teplizumab.
• ▪Sanofi asked the Food and Drug Administration to pull teplizumab out of Commissioner Marty Makary's speedy drug review program.
• ▪The article about Sanofi withdrawing teplizumab from FDA review was published on May 6, 2026.
• ▪Teplizumab is a type 1 diabetes drug.

Political interference in drug review

• ▪Acting Center for Drug Evaluation and Research Director Tracy Beth Høeg disagreed with a staff decision to approve teplizumab.
• ▪It is rare for a center director to become involved in scientific review of a single drug at the Food and Drug Administration.
• ▪Drug approval decisions at the Food and Drug Administration are typically made by career scientists.

Høeg's role as center director

• ▪Tracy Beth Høeg is a political appointee serving as acting Center for Drug Evaluation and Research Director.

Makary's expedited review program

• ▪Marty Makary told CNBC that he stands behind review teams.
• ▪Marty Makary told CNBC that disaster occurs whenever political leaders overrule scientific staff.
• ▪FDA Commissioner Marty Makary created a new speedy drug review program.

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