Today, the FDA announced the appointment of Sally Choe, PhD to succeed Kathleen (Cook) Uhl, M.D. as Director of the Office of Generic Drugs (Cook’s last day at OGD will be March 2). Dr. Choe currently serves as Deputy Office Director, Office of Study Integrity and Surveillance within Office of Medical Products and Tobacco, Center for Drug Evaluation and Research, Office of Translational Sciences, FDA. Before her current FDA position, she served as Senior Director at Parexel (2011-2016) and was a Team Leader at the FDA from 2006 – 2011. She also did brief stints at Pfizer as a Manager and at BMS as a Research Investigator. She has a Ph.D. in Pharmaceutics from University of Michigan earned in 2000 and a BS in electrical engineering from Virginia Tech (earned in 1988).
It was once thought that OGD would be recruiting another M.D. to lead the Office; however, other OGD Directors have had Ph.D.s. This appointment came as a complete surprise to us in industry, and I think to those at the Agency as well, as it was one of the best kept secrets the Agency may have ever held. While some hints at the Association for Accessible Medicines annual meeting last week suggested that paperwork might be in the works for the OGD Director position, industry felt it might be a few months until an appointment was made. No leaks at the Agency for certain! Maybe the White House should take a lesson.
Looks like we will have to wait to learn more about Dr. Choe once the announcement is out. We all wish her the best in this important position within the Center for Drug Evaluation and Research.