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FDA drug evaluation center plans reorganization
Review of ophthalmic drugs will be combined with review of anti-infective drugs.
The Food and Drug Administration is undertaking a reorganization of its Center for Drug Evaluation and Research, according to an FDA newsletter. The change will occur when the center moves to White Oak, Md., later this year, according to the document.
The Center for Drug Evaluation and Research (CDER) has been planning the reorganization since 2002, with the arrival of John K. Jenkins, MD, as director of the FDA’s Office of New Drugs (OND).
“When I became the director of OND in January 2002, one of my first goals was to review our organizational structure in order to ensure that we were best aligned to efficiently and effectively implement the upcoming reauthorization of the [Prescription Drug User Fee Act] program,” Dr. Jenkins said in a statement describing the reorganization proposal. His statement was supplied to Ocular Surgery News by the FDA press office.
Under the Prescription Drug User Fee Act, companies pay a fee to the FDA in return for a timely review process, according to the CDER. Every 5 years, the user fee program has to be reauthorized by Congress.
The current structure of the CDER has been in place since 1994, according to the FDA. Since that time, the review of new drugs has been organized according to therapeutic area, Dr. Jenkins said.
Under the reorganization, the review of ophthalmic drugs will be combined with the review of anti-infectives in a Division of Anti-Infective and Ophthalmology Products.
According to Christine S. Parker, a public affairs specialist at the CDER, the organizational change should not affect the way ophthalmic drugs are reviewed. Wiley Chambers, MD, an FDA official who has long been involved in the review of ophthalmic drugs, will remain the deputy division director for ophthalmic drugs, she said.
There are no changes expected for the Center for Devices and Radiological Health, the arm of the FDA that reviews ophthalmic devices, she said.
Office of New Drugs
The reorganization is meant to help the CDER better comply with the Prescription Drug User Fee Act of 1992, according to the statement from Dr. Jenkins. The changes combine some divisions and create new ones to more efficiently review drug products, he said.
“While the new OND structure is not ‘perfect,’ we believe that implementation of this new structure will provide us with a solid foundation on which to build further improvements in our new drug review and approval process to better meet our important public health mission,” Dr. Jenkins said.
“My three primary goals for the reorganization are to better balance the allocation of available resources against workload, improve the logical grouping of clinical indications within OND’s division and office structure, and complete the integration of the therapeutic biologics into OND’s indication-based structure,” he said.
Offices of Drug Evaluation
In the reorganized OND there will be six Offices of Drug Evaluation (ODE), increased from five previously, Dr. Jenkins said. Biologics, formerly reviewed by another arm of the FDA, will now be included in the appropriate ODE based on their indications, he said.
There will be a new Office of Oncology Products to focus on drug development for the diagnosis, treatment and prevention of cancer. This office will include the Division of Drug Oncology Products, the Division of Biologic Oncology Products and the Division of Medical Imaging and Hematology Products.
ODE I will include the Division of Cardiovascular and Renal Products, and the current Division of Neuropharmacologic Drug Products will be divided into two divisions, the Division of Neurology Products and the Division of Psychiatry Products.
ODE II will include the Division of Pulmonary and Allergy Products and the Division of Metabolism and Endocrinology Products. A new Division of Anesthesia, Analgesia and Rheumatology Products will be created, combining product groups and staff from the Division of Anesthetics, Critical Care and Addiction Drug Products and the Division of Anti-Inflammatory, Analgesic and Ophthalmologic Drug Products.
ODE III will include the Division of Reproductive and Urology Products, the Division of Gastroenterology Products and the Division of Dermatology and Dental Products.
ODE IV will be called the Office of Antimicrobial Products. In the reorganization, staff from ophthalmology will be added to the Division of Anti-Infective Drug Products to form the Division of Anti-Infective and Ophthalmology Products. ODE IV will also include the Division of Special Pathogen and Immunology Products and the Division of Anti-Viral Products.
A newly created Office of Non-Prescription Products will cover products currently under the Division of Over-the-Counter Products.
For Your Information:Reference:
- John K. Jenkins, MD, is the director of the Office of New Drugs, CDER, FDA. He can be reached through Christine S. Parker, a public affairs specialist in the FDA’s Division of Public Affairs, at 301-827-7251; fax: 301-827-3055; e-mail: parkerc@cder.fda.gov.
- Food and Drug Administration. News Along the Pike. Available at: www.fda.gov/cder/pike/Dec2004.htm.
- Jeanne Michelle Gonzalez is an OSN Staff Writer who covers all aspects of ophthalmology, specializing in practice management, regulatory and legislative issues. She focuses geographically on Latin America.