Office of New Drugs Reorganization

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FDA/Center for Drug Evaluation and Research

The reorganization of CDER's Office of New Drugs (OND), as announced in September 2004, is now in the process of being implemented. Although the original plan for restructuring drug groups and divisions was intended to coincide with CDER's move to the new White Oak campus in the spring of 2005, the reorganization will now be carried out in a staged manner over several months. OND's senior management based this decision on the move to White Oak being delayed to late summer/early fall, internal changes in personnel, and other logistical realities. The implementation will occur in three phases, which allows for a more gradual movement of products and staff between divisions. The phases of the implementation of the reorganization are described in detail below.

PHASE 1:

Phase 1 of the reorganization began in May 2005 and is now complete. Phase 1 involved the elimination of the Office of Drug Evaluation V and the movement of the products and staff from that ODE to other ODEs and divisions within OND. In each of the actual organizational shifts, staff and products were moved together to new reporting units, as follows:

The Division of Over-the-Counter Drug Products was reorganized and is now the Office of Nonprescription Products (ONP), and reports directly to the OND Director. Dr. Charles Ganley is the Director of ONP.
The Division of Dermatology and Dental Products (DDDP) has been relocated to ODE III. Dr. Jonathan Wilkin is the Director of DDDP and reports to Dr. Florence Houn, the Director of ODE III.
The former Division of Anti-Inflammatory, Analgesic, and Ophthalmologic Drug Products (DAAODP) was split into two review groups and these groups were merged with two existing divisions to create new divisions.

The ophthalmology products and staff were merged with the former Division of Anti-Infective Drug Products to create the new Division of Anti-Infective and Ophthalmologic Products (DAIOP) in ODE IV. Dr. Janice Soreth is the Director of DAIOP and reports to Dr. Mark Goldberger, the Director of ODE IV.
The analgesic and anti-inflammatory drugs and staff were merged with the former Division of Anesthetic, Critical Care, and Addiction Drug Products to create the new Division of Anesthesia, Analgesia, and Rheumatology Products (DAARP) in ODE II. Dr. Robert Rappaport is the Director of DAARP and reports to Dr. Robert Meyer, the Director of ODE II.

The Botanicals Review Team has been relocated to ODE I, and reports to Dr. Robert Temple, the Director of ODE I.

PHASE 2:

Phase 2 of the OND reorganization will occur in early July 2005. At that time, the new Office of Oncology Drug Products (OODP) will begin to operate. Dr. Richard Pazdur will be the Director of OODP and will report directly to the OND Director. The OODP will include three divisions that will be realigned from other ODEs within OND:

The Division of Oncology Drug Products (DODP) will move from ODE I. Dr. Robert Justice will be the Acting Director of DODP.
The Division of Biological Oncology Products (DBOP) will move from ODE VI. Dr. Patricia Keegan will continue as the Director of DBOP.
The Division of Medical Imaging Drug Products (DMIDP) will move from ODE III. Dr. George Mills will continue as the Director of DMIDP.

Phase 2 of the reorganization also involves the split of the current Division of Neuropharmacological Drug Products (DNDP) in ODE I into two new divisions.

Neurology products and staff will be assigned to the new Division of Neurology Products (DNP). Dr. Russell Katz will be the Director of DNP and will report to Dr. Robert Temple, the Director of ODE I.
Psychiatry products and staff will be assigned to the new Division of Psychiatry Products (DPP). Dr. Thomas Laughren will be the Acting Director of DPP and will report to Dr. Temple.

PHASE 3:

Phase 3 of the OND reorganization is expected to occur in September 2005, coincident with OND's move to the White Oak facility. In Phase 3, OND will complete the integration of therapeutic biologics into the indication-based application assignment structure. This means that the therapeutic biologics and staff currently located in the Division of Therapeutic Biological Internal Medicine Products (DTBIMP) and the Division of Review Management Policy (DRMP) in ODE VI will be reassigned to other ODEs and divisions within OND based on the therapeutic indication for the product. At the completion of this transfer process ODE VI will be eliminated. Delaying the integration of the therapeutic biologics until the move to White Oak provides several advantages that will serve to ensure a smooth transfer. These advantages include allowing adequate time for the other divisions and offices to be up and running in their new configurations and, thus, better prepared to receive the therapeutic biologic applications and the expert staff that support them. In addition, this timing will avoid the need for ODE VI staff to physically move more than once and will ensure the most seamless access to documents and databases needed to manage the review of these applications.

Also in Phase 3, hematology and coagulation products and staff from the current Division of Gastrointestinal and Coagulation Drug Products in ODE III will be merged with the Division of Medical Imaging Drug Products to create the new Division of Medical Imaging and Hematology Products (DMIHP) in OODP. Dr. George Mills will continue as Director of DMIHP. Gastroenterology products will remain in the new Division of Gastroenterology Products (DGP) in ODE III. Dr. Brian Harvey will continue as Director of DGP and will report to Dr. Houn.

The Office of New Drugs is working diligently to ensure that these changes happen as smoothly as possible, but does anticipate that there will be bumps along the road to the newly reorganized structure. It is hoped that the staged implementation of the reorganization, in conjunction with the staged move to White Oak, will help to minimize the difficulties associated with such major changes.

Questions regarding the reorganization should be directed to the Office of New Drugs Immediate Office (ondeio@cder.fda.gov).

Date created: June 21, 2005; Updated June 22, 2005