The US Food and Drug Administration (FDA) is losing yet another major figure from its drug regulatory staff, agency officials confirmed today.
The Office of Pharmaceutical Science (OPS) is a sub-office of the Center for Drug Evaluation and Research (CDER), the entity within FDA charged with regulating chemical and some biological drug products.
In September 2012, OPS underwent a major reorganization, ceding much of its authority over pharmaceutical quality to a new Office of Pharmaceutical Quality (OPQ) and divesting itself of the Office of Generic Drugs (OGD), which then became its own so-called "Super Office."
OGD was then led for a short time by Greg Geba, who has only been with FDA since July 2012 after joining from Sanofi US. However, Geba left FDA in March 2013, citing conflict with his "original and full vision for OGD's remit." Geba was replaced by Kathleen "Cook" Uhl on an acting basis while the search for a permanent director continues.
A New Departure
Now FDA has confirmed that OPS's acting director, Keith Weber, will be stepping down from the agency.
"It is with mixed emotions that I announce the retirement of a longstanding CDER senior leader, Keith Webber, Ph.D., acting director of OPS," wrote CDER Director Janet Woodcock in an email to staff on 19 September 2013.
Webber will be transitioning from FDA to Perrigo, Woodcock said, citing his desire to balance his time between public health and his family.
Webber has worked at FDA for nearly 20 years, first with the Center for Biologics Evaluation and Research (CBER) for eight years and then with OPS for more than 10.
Woodcock cited Webber as a major figure in the agency, responsible for the "successful implementation of numerous initiatives," including:
- the integration of the Office of Biotechnology Products (OBP) and biologic license applications (BLAs) into CDER
- the groundbreaking work for the Generic Drug User Fee Amendments of 2012 (GDUFA) and the advancement of the generic drug program
- the approval of more than a thousand abbreviated new drug applications (ANDAs), including numerous medically necessary products such as low molecular weight heparin
- the strategic planning to prepare OGD for GDUFA challenges
- leading and implementing a new review flow system for generic drugs
- the modernization of the OPS governance structure
- championing the development and implementation of the Quality Management System
In an email to Focus, Webber said he was leaving FDA on good terms.
"I think it is
important for people to know that CDER's reorganization of its quality functions is not a factor in my decision to leave the FDA. I strongly support the Center's heightened focus on drug quality. I'm glad I could help with the transitioning of the Office of Generic Drugs into a "super office" and be actively involved in discussions and planning for the new Office of Pharmaceutical Quality," he said.
Webber added that the Perrigo opportunity had come "recently and unexpectedly," and that he felt Perrigo's focus on and commitment to quality was a "strong draw."
"I feel I can add value and perhaps some perspective from my years at CBER and CDER to their work. So now is a good time to make this move," he added.
Exit, Webber; Enter, Yu
Replacing Webber will be Lawrence Yu, currently Acting Deputy Director of OPS. Woodcock cited Yu as an "internationally recognized expert in pharmaceutical science," and said he had already played a "key role" in helping to create OPS.
Yu formerly worked for Uphohn (now a Pfizer subsidiary) and GlaxoSmithKline in pharmaceutical development, but has worked at FDA for the last 13 years.
"With his unique qualifications, Lawrence brings to the position a thorough understanding of both real-world manufacturing and the regulations related to new and generic drug products," Woodcock wrote. "I am excited to be working with him during this critical period in the evolution of CDER's quality program."