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