CDER Runs into Trouble with Generic Drug Reorg Plan


Applied Clinical Trials

After less than a year on the job, the head of FDA’s Office of Generic Drugs (OGD) has announced his departure, a sign that all is not well with plans for major organizational changes at the Center for Drug Evaluation and Research (CDER).

Dr. Gregory Geba, who was appointed OGD director last July (2012), says “I entirely support” plans to shift all the chemists out of OGD to a new Office of Pharmaceutical Quality (OPQ), as proposed by CDER director Janet Woodcock.  Yet his memo of March 13 announcing his resignation indicates considerable frustration with the situation. Geba came to FDA from Sanofi, he says, to help “pave the way” for extending generics from conventional pills to more complex dosage forms, and to address a broad range of complex quality and regulatory issues. But he notes that the shift of his chemistry group to OPQ will limit OGD resources and “inevitably resets the scope of responsibilities and remit of our office.”

Ever since the OPQ proposal emerged last fall, OGD staffers have voiced concerns that combining generic and new drug review chemists in the same operation would decimate OGD and complicate the generic drug review process. Moreover, the change appears to counter Woodcock’s move last September of elevating OGD to “super office” status, with Geba reporting directly to her.

Similarly, staffers in CDER’s Office of Compliance are leery about OPQ swallowing up much of its Office of Manufacturing and Product Quality. The idea is to combine operations responsible for evaluating CMC data in applications for new drugs and generics with those overseeing compliance with good manufacturing practices, but so far, the change appears disruptive to many CDER officials.

Whatever the merits of Woodcock’s organizational changes, Geba’s sudden departure comes at a difficult time. OGD and manufacturers are immersed in the details of implementing a major new user fee program as well as issuing new guidance and refining programs to smooth the development and approval of safe and high quality generic products. Geba noted in his memo that OGD has approved nearly 200 Abbreviated New Drug Applications (ANDAs) since it began collecting user fees last October, and that it’s beginning to whittle down the massive application backlog.

He also notes that to continue these improvements, OGD plans to hire 100 new staffers and to implement a number of new initiatives – prospects that likely will be undermined by depleted resources under the current budget sequester and a continued impasse in Congress over spending limits. No surprise that someone with a strong resume might not want to stay around to deal with all of this.   

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