FDA’s top generic drug leader puts in her 2 weeks as GDUFA III looms

The FDA is about to lose another top leader with the departure of Sally Choe, director of the FDA’s Office of Generic Drugs, on Oct. 8. The departure coincides with the transition from the second reauthorization of the Generic Drug User Fee Amendments to the third reauthorization, which Congress has until Friday to finish up.

Patrizia Cavazzoni

Choe, who didn’t immediately say where she’s heading post-FDA, but did a stint at Parexel, has served as the OGD director since Feb. 2019, and “has been the principal medical and technical authority on all matters related to generic drug review and advised me and other agency officials,” CDER director Patrizia Cavazzoni said in an email to staff announcing Choe’s departure.

With more than two decades of drug development experience, Choe focused her OGD efforts on complex generics, reducing the number of review cycles for new generics, and “played a critically important role in ensuring access to medications during the pandemic when supply chains were strained,” Cavazzoni wrote. FDA declined to comment on where Choe is moving to.

Susan Rosencrance

Taking over for Choe in the interim will be Susan Rosencrance, who’s currently director of the FDA’s Office of Lifecycle Products in the Office of Pharmaceutical Quality, and has over 30 years of experience at FDA/CDER, including over 24 years in OGD.

“She will work with Sally, Iilun Murphy, and the rest of the OGD leadership team to ensure a smooth transition at this important time as we close out a successful GDUFA II program and prepare for GDUFA III,” Cavazzoni said.

Jacqueline Corrigan-Curay

While Republicans and Democrats have agreed in principle to a deal that would attach GDUFA III and the other prescription drug, biosimilar and medical device user fee deals to the short-term government spending bill, the bill still needs to get done before Friday to avoid a government shutdown and pink slips for thousands of FDAers.

Cavazzoni also said that Jacqueline Corrigan-Curay, CDER’s principal deputy center director, will lead the search for a permanent OGD director.

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