Kathleen Uhl, an FDA veteran but relative newcomer to generic drugs, has become the third director for the Office of Generic Drugs in as many workdays.

Uhl’s March 19 appointment as acting director comes less than a week after FDA said CDER Director Janet Woodcock would assume the acting director role while FDA initiates a nationwide search for a permanent director to replace Gregory Geba who departed March 15 after only eight months on the job. FDA declined to comment on what caused the sudden shift in OGD leadership from Woodcock to Uhl.

“The fact that Woodcock was only acting director for a few days says to me that Dr. Geba’s departure was unexpected,” Kurt Karst, a director at Hyman, Phelps and McNamara PC said.

Geba left FDA mainly because a planned reorganization of chemistry reviews left him unable to fulfill his vision for OGD Also see "FDA’s Generics Office Loses Another Director As Geba Makes Quick Exit" - Pink Sheet, 14 March, 2013..

Uhl has been with the agency since 1998 but only recently joined OGD in January as a senior advisor to the director and appears to be an unknown to the generic industry.

“We have not worked with Dr. Uhl before,” Ralph Neas, CEO of the Generic Pharmaceutical Association, told “The Pink Sheet.” Karst echoed the sentiment, saying he did not know Uhl, leaving him uncertain about what to expect during her OGD leadership.

Despite Uhl’s short OGD tenure and lack of generic industry notoriety, Woodcock told “The Pink Sheet” that Uhl “pretty much knows the scoop by now.” In a Tuesday memo to CDER staff Woodcock said she was confident in Uhl’s abilities to lead OGD during a “critical juncture” as it focuses on implementing the Generic Drug User Fee Act of 2012 and evolving quality throughout CDER.

Prior to joining OGD, Uhl, a clinical pharmacologist, most recently served as CDER’s deputy director in the Office of Medical Policy from 2010 until January. She helped lead OMP as it transitioned into a “super office,” a move that OGD is currently undergoing Also see "Generic Drugs Gain Status Boost Within CDER" - Pink Sheet, 7 September, 2012..

During her time at OMP, Uhl was also “instrumental” in the negotiations for the Biosimilar User Fee Act of 2012, Woodcock said.

And before joining OMP, Uhl worked outside of CDER serving as assistant commissioner for Women’s Health and as director of FDA’s Office of Women’s Health for five years Also see "Office Of Women's Health Gets Permanent Director" - Pink Sheet, 21 November, 2005..

In her 15 year FDA career, Uhl also was a reviewer in the Office of Clinical Pharmacology & Biopharmaceuticals and deputy division director of the Office of Post-Marketing Drug Risk Assessment. Outside of FDA, Uhl, a retired officer of the United States Public Health Service, also retains faculty appointments as associate professor in family medicine and internal medicine at the Uniformed Services University.

Permanent Replacement Key

While the generic industry remains unclear how to react to the new interim director given her lack of OGD experience, stakeholders emphasized the continued importance of quickly installing a permanent leader in the generic office.

GPhA remains “deeply concerned” about the absence of a permanent OGD director, Neas said, particularly since prior to Geba’s short stint with the agency OGD lacked a permanent director for two years. Following Geba’s resignation Neas said the vacancies and changes could distract from OGD’s mission “and slow the flow of information, guidance and approvals needed to achieve an optimal generic drugs market” Also see "FDA Generics Director’s Departure Shows Why Chemistry Matters" - Pink Sheet, 18 March, 2013..

Karst said he didn’t expect Uhl’s appointment to “make a huge difference in the day-to-day,” but added that in the “long term you want someone to lead the office and it is difficult … when you’re only acting director.”

FDA Generics Office Gets Third Director In Three Workdays; Uhl Brings Policy, Pharmacology Experience

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