Posted 15 January 2015
By Alexander Gaffney, RAC
The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD)—the office charged with overseeing and approving all generic drug products in the US—is finally getting a permanent leader, the agency has confirmed.
Filling a Void
In an email to FDA staff, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), said the agency had decided to hire Kathleen "Cook" Uhl as the permanent director for OGD.
Uhl had been serving as acting director of OGD since March 2013, when its former permanent head, Greg Geba, announced his resignation. Geba, who had only been in the position since July 2012, had been hired to oversee OGD at a particularly important time for the office.
The Generic User Fee Act (GDUFA) provisions of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) had instituted changes that have funneled hundreds of millions of dollars into FDA for the expressed purpose of better regulating generic drugs. The money, collected from user fees assessed on generic drug manufacturers and generic drug applications, are meant to decrease a backlog of generic drug applications, approve new generic drug applications more quickly and oversee generic drug manufacturing facilities across the globe more equitably.
In a statement, Geba said he had left in part because of major changes within FDA, which were set to shift OGD's oversight of generic drug quality to a just-launched Office of Pharmaceutical Quality.
Overseeing Big Changes
The promotion of Uhl to the position of permanent director of OGD has been expected by many. Uhl is a 30-year veteran of FDA, and has already overseen some massive changes at OGD, including the promotion of OGD to a so-called "Super Office" reporting directly to Woodcock. The new OGD includes four new offices, and according to FDA "will allow the Agency to conduct reviews of generic applications in a much more timely and effective manner while meeting GDUFA goals that become more rigorous and challenging each year."
Uhl has also overseen OGD's implementation of GDUFA, which has had some success in decreasing application backlogs and increasing FDA inspections of foreign generic drug facilities.
In an email to FDA staff, Woodcock called Uhl a "highly-regarded leader" and said she had done an "extraordinary job as the acting director of OGD."