Generic Industry Once Again Must Get To Know New US FDA Office Director

Incoming Office of Generic Drugs Director Sally Choe is largely unfamiliar to industry, but potentially offers a new perspective.

Like her predecessor, Sally Choe likely will have to spend some time getting to know industry and other stakeholders once she becomes director of the US FDA's Office of Generic Drugs.

Choe, whom the agency announced Feb. 12 will take over for Kathleen Uhl in March, appears to be a relative unknown to the generic industry. Several stakeholders indicated they had not worked with her or interacted with her in a generics capacity previously.

However, outsider status may not be a disadvantage. Choe's brand industry and pharmacology experience within FDA could provide a fresh perspective to OGD.

Kiran Krishnan, senior VP of global regulatory affairs for Apotex Inc., told the Pink Sheet that Choe's "vast experience working on the new drug side, and more recently as the deputy director at Office of Study Integrity and Surveillance, will provide great value in maintaining the progress that’s been made on the GDUFA II commitment."

Choe currently is deputy director of the Office of Study Integrity and Surveillance in the Center for Drug Evaluation and Research's Office of Translational Sciences, a position she has held for more than two years. Choe has worked in the FDA bioresearch monitoring program and directed inspections of bioequivalence and bioavailability studies and non-clinical laboratories.

Choe also led the metabolism and endocrinology team in the OTS Office of Clinical Pharmacology during a previous stint at FDA that ran from 2006-2011 and directed clinical and pharmacology review and evaluation of NDAs, BLAs and INDs, including original applications and amendments.

In addition, she held several positions at consulting and brand drug firms. (See sidebar below.)

Adopting a new drug approach may be beneficial for the generic industry, especially as it begins to develop copies of more complicated products. Association for Accessible Medicines President Chip Davis recently told members they should act like their brand competitors, although it was in a lobbying context. (Also see "Generic CEOs Need To Act Like Brand Execs, Association Head Says" - Pink Sheet, 5 Feb, 2019.)

Attorney Kurt Karst, director at Hyman, Phelps and McNamara, said her regulatory and educational backgrounds will be helpful, but did not expect radical changes to OGD operations.

"GDUFA is moving along. She is going to be picking up that baton and continue to move it forward," he said. "My guess is things are going to run like they have under the Uhl era."

Some public relations still may be required, however. Keith Webber, VP at Lachman Consultants and a former acting OGD director, said Choe is very smart and capable, adding that she should try to learn and at least understand sponsors' perspectives on relevant issues.

"It is good to listen to what industry’s concerns are," Webber said. "Of course, you can’t always make industry happy, but knowing what makes them happy and what makes them unhappy is valuable information."

Uhl also was an outsider when named acting OGD director in 2013 and then permanent director in 2015, having previously worked in the Office of Women's Health and Office of Medical Policy. She also is a clinical pharmacologist. (Also see "FDA Generics Office Gets Third Director In Three Workdays; Uhl Brings Policy, Pharmacology Experience" - Pink Sheet, 19 Mar, 2013.)

By holding the position in an acting context for two years, Uhl was in front of stakeholders on multiple occasions and proved she could handle the permanent appointment. (Also see "GDUFA Success Depends On Industry Changes As Much As Review Improvements, FDA Says" - Pink Sheet, 4 Nov, 2013.)

Choe Not A Doctor, Breaking Recent Tradition

Choe and Uhl will differ somewhat in their medical background. Unlike Uhl, Choe is not a physician. She holds a bachelor's degree in electrical engineering and masters and doctoral degrees in pharmaceutics.

Choe would be the first non-physician permanent OGD director since Gary Buehler, a pharmacist, departed the position in 2010. Uhl's predecessor, Gregory Geba, also was a physician, although he did not stay at the agency long. (Also see "FDA Office Of Generic Drugs Director Has Brand Industry Background" - Pink Sheet, 13 Jul, 2012.)

Robert Pollock, senior advisor and outside director to the board at Lachman Consultants, who is a former acting deputy OGD director, wrote in a blog post that it was thought FDA would recruit another physician to lead OGD. However a medical degree was not mandatory. FDA's educational requirements were doctoral-level, including a Ph.D, M.D., Pharm. D, or doctor of veterinary medicine.

Physician credentials likely would serve a ceremonial purpose, rather than a practical one. Someone who can prescribe generics could help project confidence in the products the agency approves. OGD director is largely a managerial position, meaning Choe likely will not be heavily involved in the technical reviews of applications.

There is a similar unwritten rule that the FDA Commissioner should be a physician. But the top spot at FDA is a political, as well as a managerial, position that rarely is involved in application reviews. (Also see "Gottlieb Joins HHS Transition Team; Will Next Stop Be FDA?" - Pink Sheet, 1 Dec, 2016.)

Decision Speed Surprises

Adding to the list of surprises related to Choe's hiring is its timing.

Some thought that even though a search for Uhl's replacement had been ongoing for several months, a new permanent director would not be in place in time for her departure, forcing the appointment of an acting director.

FDA avoided the need for a caretaker director despite conducting a national search that included internal and external candidates.

"The director of the Office of Generic Drugs position is highly visible to qualified candidates, and the vacancy announcement posted internally and externally," the agency said. "The executive search committee recruited qualified candidates from all sources to select the new OGD director."

Settling on an internal candidate should ease the transition process, which will occur over the next two weeks. Uhl announced in July 2018 that she would retire from the agency at the end of February, allowing seven months for a new director to be chosen and for the candidate to join the agency before she left. (Also see "Generics Office At US FDA Could Get New Director Before Uhl Departs" - Pink Sheet, 19 Jul, 2018.)