FDA Commissioner Marty Makary is out, and Sanofi’s diabetes prevention drug Tzield is already catching the fallout.
Reports that President Trump signed off on Makary’s removal first surfaced last Friday. Trump denied the account, originally from The Wall Street Journal, then appeared to confirm it over the weekend. Kyle Diamantas steps in as acting commissioner.
The leadership gap runs deeper than one resignation. CBER and CDER, FDA’s two primary drug review divisions, are both currently led by temporary directors. Makary’s departure adds the commissioner’s office to that list, leaving FDA’s senior review structure without permanent leadership at any level.
Into this void landed a concrete problem: Sanofi asked FDA to remove Tzield from the Commissioner’s National Priority Review (CNPV) program, one of Makary’s signature initiatives for expediting certain drug reviews. Acting CDER director Tracy Beth Høeg had apparently intervened in Tzield’s review before Sanofi made the request. Tzield, a diabetes prevention drug, won’t be the last sponsor to reassess a CNPV filing under these conditions.
The back-and-forth from the White House on Makary’s status, deny Friday, confirm later, illustrates how the health department handles transparency. Drug sponsors with active CNPV applications now face real uncertainty about whether the program continues under Diamantas or gets quietly shelved.
Diamantas inherits the question. He hasn’t answered it yet.
— Sarah Chen