March 20, 2013

OGD Director Resigns and Is Replaced by Kathleen Uhl, M.D.

Thumbnail image for FDA logo.jpgIn a surprising turn of events, last week FDA's new Office of Generic Drugs ("OGD") Director Gregory P. Geba, M.D., M.P.H., voluntarily stepped down from his post after only about eight months after being announced as the new Director. Rather than hiring from within, FDA hired Geba from Sanofi US, where he had previously most recently served as Deputy Chief Medical Officer. FDA said then, "He [Geba] joins OGD at an opportune time to lead our expanding generic program into a reorganization of both structure and process to improve coordination, communication, and efficiency, as well as enhance the Office's ability to ensure that all generic drugs--which make up nearly 80 percent of prescriptions filled in the United States--are safe, effective, of high quality, and interchangeable with the brand name drug product/reference listed drug." Around this same time, FDA moved OGD to the same organizational level as the Office of New Drugs ("OND"), called a "Super office," signaling that the two offices now had the same reporting structure directly to the Director of the Center for Drug Evaluation and Research ("CDER"), Janet Woodcock, M.D., rather than a sub-office, as had previously been the case.

According to reports of an e-mail that Geba sent to FDA staff on March 13, Geba cited the movement of OGD's chemistry divisions into a new Office of Pharmaceutical Quality as one of the lead reasons for his resignation, as well as the relocation of his family to the Washington area. Geba reportedly wrote: "As I see it, two of the original reasons I came to [OGD] . . . would be challenged by resources needed for application to other extremely important efforts of the chemistry group in moving to [the Office of Pharmaceutical Quality." The e-mail explained that while Geba generally supported the transfer of the chemistry group to the Office of Pharmaceutical Quality. Geba thought, however, that the move could make it difficult for him to achieve his goals to approve generic versions of inhalers, topical creams, and other complex drugs, as well as addressing the importance of pill size, shape, color, and other characteristics to patients.

Geba helped FDA with its initial phases for implementing the Generic Drug User Fee Act ("GDUFA"). According to Geba, since GDUFA, OGD decreased the abbreviated new drug application ("ANDA") backlog by nearly 600 applications and approved nearly 200 ANDAs since October 2012.

Following last week's announcement of Geba's departure, the Generic Pharmaceutical Association ("GPhA") issued a press release indicating its disappointment that FDA has not been able to select and retain consistent and reliable leadership in OGD since 2010, stating:

From 2010 to 2012, the Office of Generic Drugs had no leadership. Now, with Dr. Geba's departure, we are significantly concerned about further disruption at the FDA. These vacancies and changes hold the potential to distract from the critical mission of the OGD, and slow the flow of information, guidance, and approvals needed to achieve an optimal generic drugs market for patients, payors, and the health care system. Yesterday, CDER trade press shared a CDER staff memo dated March 19, 2013 that announced Kathleen ("Cook") Uhl, M.D., would be OGD's Acting Director. Uhl has already worked for 15 years at FDA and was most recently the Senior Advisor to the Director for OGD.

Given that it took FDA several years to find a new OGD Director, it is unclear what timetable FDA is operating under to find a replacement. Perhaps given FDA's relatively recent selection for Geba, however, there may be ready candidates for FDA to consider and help alleviate the generic industry's concerns.