Another day, another high-level departure from FDA: This time, it's head of generic drugs

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  • Another day, and we have another senior level departure from the Food and Drug Administration

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  • The abrupt resignation of Dr. Greg Geba of the Office of Generic Drugs is part of a worrying spate of high-level departures inside the FDA

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  • The departure of FDA officials has the potential to create a real brain drain should the trend persist

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Another day, and we have another senior level departure from the Food and Drug Administration.

The memo below — circulated this afternoon inside FDA — announced the departure of the head of the drug center’s Office of Generic Drugs, Dr. Greg Geba. It’s noteworthy that this new chief had only been in his slot for less than a year.

His abrupt resignation is part of a worrying spate of high-level departures inside the drug center that, taken together, have the potential to create a real brain drain should the trend persist. Filling these high-level positions is no easy feat, and Geba had been recruited from outside FDA, from a position as deputy chief medical officer at Sanofi.

For FDA, recruiting external candidates into senior roles can be much more difficult, and take more time, than selecting internal applicants. For these and other reasons, FDA is often guilty of promoting too much from within; a habit that has certain advantages (internal hires know the agency’s unique traditions and precedents) but also drawbacks (promoting only from within can create an insular culture and deny the agency new perspectives). So when a high-level external recruit leaves after such a short period of time, it could make the agency more reluctant to take a chance on external hires down the road.

From: CDER Center Director
Sent: Wednesday, March 13, 2013 02:32 PM
To: FDA-CDER-wide
Subject: Changes in CDER’s Office of Generic Drugs
CDER Staff:

I would like to make you aware of a change in the Office of Generic Drugs’ (OGD) leadership.

Dr. Greg Geba, OGD director, has informed me that he will resign from his position on March 15. With the pending realignment of OGD’s CMC functions into the new Office of Pharmaceutical Quality (OPQ), which Dr. Geba fully supports as part of the quality evolution in CDER, he nonetheless saw this movement as creating challenges for implementing his original and full vision for OGD’s remit. Additionally, it put into new perspective considerations for him relocating his family to the Washington, D.C. area.

Dr. Geba came to CDER during a busy time and has led OGD’s work to improve efficiencies in the generic drug review process — significantly reducing the backlog of pending ANDAs, preparing for the hiring of new staff, and successfully guiding OGD in implementing the Generic Drug User Fee Act (GDUFA), as well as overseeing OGD-related organizational changes to stand up the new OPQ.

Please join me in thanking Dr. Geba for his significant contributions and wishing him well.

In the interim, I will serve as the acting OGD director while we initiate a nationwide search for our next OGD director.

Janet Woodcock


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