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Office of New Drugs Reorganization
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).
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Date created: June 21, 2005; Updated June 22, 2005 |
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