FDA announces changes in drug centers oncology office
For Immediate Release: Sept. 12, 2011
Media Inquiries: Erica Jefferson,
301-796-4988,
[email protected]
Consumer Inquiries: 888-INFO-FDA
FDA announces changes in drug center’s oncology
office
Review divisions to be aligned by expertise,
disease-specific areas
Today, the U.S. Food and Drug Administration announced
organizational changes within the office responsible for reviewing
all drug and biologic applications for cancer therapies. The Center
for Drug Evaluation and Research’s (CDER) Office of Oncology
Drug Products has been reorganized and renamed the Office of
Hematology and Oncology Products (OHOP).
“Under the new office structure, the agency anticipates
greater clarity and more transparent interactions with companies
about the requirements to bring cancer treatments to market,”
said CDER director Janet Woodcock, M.D. “We don’t
expect these changes to slow down pending applications, in fact, we
expect to see greater efficiencies that will better support our
work to get cancer treatments to patients.”
Richard Pazdur, M.D., who joined the FDA in 1999 and became
director of the office in 2005, will continue to serve as the
office director. Dr. Pazdur will also continue to head the
agency-wide oncology program that coordinates oncology activities
within the FDA as well as with external stakeholders. This program
will remain in OHOP.
“As the practice of oncology and the treatments being
developed for these diseases have become more complex, we’ve
recognized the need and importance of taking a more
disease-specific review approach to these therapies,” said
Dr. Pazdur. “Reorganizing the office in this manner also
aligns FDA with the organizational structure of leading cancer
treatment centers, academic programs and the National Cancer
Institute.”
The previous structure contained three divisions: Division of
Hematology Products (DHP), Division of Drug Oncology Products
(DDOP), and Division of Biologic Oncology Products (DBOP).
The new structure contains four divisions: Division of
Hematology Products (DHP), Division of Oncology Products 1 (DOP1),
Division of Oncology Products 2 (DOP2), and Division of
Hematology Oncology Toxicology (DHOT).
Two unique features of the reorganization include the creation
of DOP1 and DOP2, the agency’s primary review divisions for
cancer solid tumor therapies, and the creation of DHOT, which will
review nonclinical information.
DOP1 and DOP2 will have disease-specific therapeutic areas of
responsibility regardless of whether the product is a drug or
biologic. DHOT is a newly created division that will be dedicated
to reviewing nonclinical pharmacology and toxicology aspects of
cancer therapies. DHP will continue reviewing hematology therapies,
including those for benign disorders and malignancies. The division
directors for each division are listed below.
New OHOP Structure and Division Therapeutic Areas
|
DOP1
|
DOP2
|
DHP
|
DHOT
|
|---|---|---|---|
| Division
Director Robert Justice, M.D., M.S. |
Division
Director Patricia Keegan, M.D. |
Division
Director Ann Farrell, M.D. |
Division
Director John Leighton, Ph.D. |
| Breast, Gynecologic, Genitourinary, Supportive care (non-hematologic) | Gastrointestinal, Lung/Head & Neck, Neuro-oncology/Rare cancers/Pediatric Solid Tumor, Melanoma/Sarcoma | Benign hematology, Hematologic malignancies, Hematology support, Pediatric Hematology | Nonclinical Review Division for Hematology/Oncology products |
OHOP at-a-glance
- 130: total employees in OHOP
- 55: number of medical oncologists in OHOP
- 39: number of pharmacists, nurses and non-clinical Ph.D.s in OHOP
- 19: Number of medical oncologists, nurses and pharmacists still treating patients
- 24: OHOP staff published in 2010
- 10: number of new drug indications approved in 2010
- 7: number of new molecular entities approved to date in 2011
For more information:
FDA: Office of Hematology and Oncology Products
FDA: Information for companies
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm271326.htm
FDA: Spotlight on Drug Innovation – Update of
FDA’s novel drug approvals in 2011
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm254242.htm
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation’s food supply, cosmetics, dietary supplements,
products that give off electronic radiation, and for regulating
tobacco products.
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