Top OGD official to depart from FDA ahead of GDUFA III

Regulatory NewsRegulatory News | 26 September 2022 |  By 

Departing OGD Director Sally Choe

Sally Choe, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD), is leaving the agency after a three-and-a-half-year stint in the role.
 
Her departure comes just before the agency is expected to begin implementing the third iteration of its Generic Drug User Fee Amendments (GDUFA III) program. While Congress has not formally reauthorized the user fee programs, it is widely expected to include the user fee package as part of a stop gap spending bill that would allow the programs to continue after their 30 September expiration.
 
On 26 September, FDA’s Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni announced that Choe will leave the agency on 8 October to “pursue opportunities outside the agency.”
 
“Since assuming the role of OGD director in February 2019, Sally has served as an invaluable member of CDER’s executive team,” Cavazzoni said in an email to her staff. “She has been the principal medical and technical authority on all matters related to generic drug review and advised me and other agency officials.”
 
Choe worked in the pharmaceutical industry before taking a job as a team leader for the metabolism and endocrinology team in CDER’s Office of Clinical Pharmacology, Office of Translational Sciences (OTS) from 2006-2011. She went back to the private sector to work for the clinical research company Parexel at its Asia-Pacific region and Japan offices before returning to FDA in 2017 as deputy office director of OGD.
 
Cavazzoni praised Choe’s accomplishments at the agency, noting that under her leadership OGD developed a modernization roadmap to improve its processes that often exceeded commitments under the Generic Drug User Fee Amendments (GDUFA). She also noted the office met or exceeded Drug Competition Action Plan milestones under Choe’s direction.
 
“Most recently, OGD played a critically important role in ensuring access to medications during the pandemic when supply chains were strained,” Cavazzoni added. “Sally’s impact on OGD and public health will be lasting.”
 
While FDA looks for a replacement for Choe, Susan Rosencrance, director of the Office of Lifecycle Products in the Office of Pharmaceutical Quality, will serve as acting OGD director.
 
Cavazzoni noted that Rosencrance has more than 30 years of experience at FDA, 24 of those within OGD. She said the acting director will work with Choe and the rest of the OGD leadership team to ensure a smooth transition and prepare for GDUFA III.

 

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