Posted 19 January 2015
By Alexander Gaffney, RAC
If you're a regulatory professional whose job includes working with the US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), you might be seeing some new names and faces in your interactions with the agency—about a thousand of them, in fact.
In an update last week to FDA staff, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), said OGD had succeeded in hiring 923 new employees as of October 2014.
OGD has been on a hiring spree as of late in an attempt to increase its staff members to meet goals set by the Generic Drug Use Fee Act (GDUFA). The law, passed in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, increased funding for FDA ($299 million per year) in return for the agency promising to make approval decisions faster, to make the approval process more predictable and to decrease a backlog of generic drug application approval decisions.
To accomplish those goals, however, FDA needed more than just money—it needed staff. Traditionally, hiring at FDA has been somewhat of a challenge. FDA typically pays less than industry for comparable positions, and it can be especially difficult for the agency to recruit high-level leadership for its divisions.
OGD's ability to hire new staff at such a rapid pace, then, was touted by Woodcock as a great success. The hiring of the employees was "almost a year ahead of schedule," she noted in a 15 January 2015 email to FDA staff.
Woodcock noted that the hiring of the staff should allow OGD to "meet the other goals set out under GDUFA," which notably includes approving most abbreviated new drug applications (ANDAs) within 10 months.
The announcement comes the same week as another major event for OGD: the hiring of a permanent director, Kathleen "Cook" Uhl.
Uhl had served as acting director of OGD since 2012.
Woodcock's letter is below:
I would like to recognize and thank everyone who has contributed to the Generic Drug User Fee Amendments of 2012 (GDUFA) hiring project. Special thanks go to FDA’s GDUFA Human Capital Team (HCT), which is comprised of staff in CDER, the Office of the Commissioner, and the Office of Regulatory Affairs.
At the CDER Town Hall on October 30, 2014, we announced that FDA had exceeded the Fiscal Year 2014 hiring goals. We also reported that as of October 20, 2014, the Agency had met its overall goal of hiring 923 employees, almost a year ahead of schedule.
And as of December 14, 2014, the Agency had hired more than 1,000 employees under GDUFA.
While the HCT provided leadership and management in the GDUFA hiring and training initiative, this was really a Center-wide and Agency-wide effort, involving strategic planning, decision making, and communications by a number of individuals and working groups.
The target of 923 hires is an Agency-wide Congressional mandate, based on the agreed number of total hires for the entire GDUFA hiring initiative, lasting until September 2015. With the efforts of countless employees Agency-wide, we have met this goal more than 11 months ahead of schedule.
I am pleased with this accomplishment because it positions the Agency to meet the other goals set out under GDUFA.
Congratulations to the HCT and those employees who have contributed to this tremendously successful effort.
-- Janet Woodcock