Facing Key Challenges, FDA's Office of Generic Drugs Seeks Deputy Director

Posted 25 February 2015 | By Alexander Gaffney, RAC 

Facing Key Challenges, FDA's Office of Generic Drugs Seeks Deputy Director

The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), fresh off the appointment of a permanent director last month, is hoping to hire someone to act as the office's second-in-command.

In a notice posted to the USA Jobs website this week, OGD, which oversees the regulation of all generic pharmaceutical products in the US, said it is trying to fill an open position for deputy director of OGD. The position would be responsible for helping to plan, manage, organize and direct "all regulatory review operations, program segments, functions and activities of [OGD]," FDA explained in the position description.

FDA said it will only consider candidates with a Doctor of Medicine (MD), at least one year of graduate training and high-level experience in drug regulation and review.

Recent and Ongoing Challenges

If FDA is able to fill the position, it would bring OGD up to full capacity for the first time in several years. In January 2015, FDA announced the promotion of Kathleen "Cook" Uhl as permanent director of OGD, ending a two-year period in which the office did not have permanent leadership.

The leadership void has come at a critical time for OGD, which has been working to implement the Generic Drug User Fee Act (GDUFA) provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) and to take on its increased responsibility as a "super office" under FDA's Center for Drug Evaluation and Research (CDER).

The generic drug industry, meanwhile, has been complaining that OGD has not been approving applications as quickly as was promised under FDASIA.


OGD Deputy Director Position Announcement

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