Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 20 March 2013
Just one week after the US Food and Drug Administration's (FDA) Director of the Office of Generic Drugs (OGD), Greg Geba, announced he would step down from his position, agency officials have announced a new acting director for the agency.
In a letter on 19 March 2013 to staff, Janet Woodock, director of the Center for Drug Evaluation and Research (CDER), announced that Kathleen "Cook" Uhl would be stepping up as acting director of the office while the search for a permanent OGD director was under way.
Woodcock explained that Uhl has been with FDA for 15 years, starting in CDER's Office of Clinical Pharmacology before rising through the ranks and notably serving as assistant commissioner for Women's Health and serving as director of the Office of Women's health.
"In her 15 years with FDA, Dr. Uhl has become widely-regarded both inside and outside of the Agency as a compassionate, committed, and dedicated leader," Woodcock said, adding that Uhl is renowned for her "strong management skills and extensive expertise in clinical pharmacology."
Both of those sets of skills will be crucial as OGD faces a unique difficulty: enacting the provisions of the Generic Drug User Fee Act (GDUFA), a piece of legislation that provides the agency with additional funding in return for a number of reforms and additional review accountability.
Major provisions that need to be undertaken this year at OGD include the collection of fees from facilities and applications, the clearing of a massive backlog of applications, the restructuring of duties, the hiring of new staff and meeting the goals set by its GDUFA commitment letter.
Uhl has recent experience in the negotiating process of a similar user fee act for generics, the Biosimilar User Fee Act (BsUFA), though Woodcock's letter does not mention having worked on the negotiations of GDUFA.
Uhl, who was Geba's senior advisor, is presumably deeply familiar with GDUFA anyway.
Geba had only joined the agency in July 2012, and at the time took over from then-acting director Keith Webber, who had taken over in March 2010 when Gary Buehler was transferred to the Office of Pharmaceutical Science (OPS), then OGD's parent office.
Geba's hiring and departure was reportedly caused by tensions in CDER regarding the direction of OGD.
His hiring came just months before Woodcock announced changes within the Office of Generic Drugs, including its elevation to a so-called "super office," affording it greater operational authority and control over reorganized sub-agencies. Before the reorganization, OGD was a sub-office of the Office of Pharmaceutical Science (OPS).
During that same reorganization, Woodcock proposed the formation of a new Office of Pharmaceutical Quality to oversee drug quality throughout the product lifecycle. Woodcock said the office would, if created, assume some functions currently vested in OPS and the Office of Manufacturing and Product Quality.
"Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety," said Woodcock. "We must be strategic and have systems in place to identify and respond to quality issues before they become problems. This is especially critical due to the global nature of drug manufacturing and the sourcing of raw materials outside of the US."
Those changes seem to have created tensions at FDA. Geba's farewell email to OGD staff notes that he came to FDA for two reasons: "to help pave the way for extension of generics across the entire therapeutic spectrum … and to address issues such as pill size, shape, color and the importance this may have for patients who use generics."
Those duties "would be challenged by resources needed for application to other extremely important efforts of the chemistry group in moving to OPQ," he argued. While he said he "supports" the move, the changes were evidently enough to cause him to reconsider his role at the agency.