According to a recent FDA announcement, the Office of Prescription Drug Promotion (OPDP) is restructuring its review process. OPDP currently reviews and analyzes its workload and review processes through two divisions: the Division of Consumer Drug Promotion, and the Division of Professional Drug Promotion. According to the March 8 announcement, pending final approval, OPDP will rename and restructure its divisions to oversee different therapeutic classes of drugs.
The divisions will be renamed and organized as follows:
The Division of Advertising and Promotion Review I:
- Neurology, Psychiatry
- Hematology/Oncology (blood cancers)
- Oncology (solid tumors)
- Analgesics, Anesthetics, Antivirals
The Division of Advertising and Promotion Review II:
- Osteoporosis, Reproductive, Urology
- Dental, Dermatology, Metabolic & Endocrine
- Allergy, Gastroenterology, Pulmonary, Rheumatology
- Anti-Infective, Cardiovascular, Medical Imaging,
- Ophthalmology, Renal, Transplant
According to Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), "As a way to distribute the work evenly, each division will oversee different therapeutic classes of drugs. These changes will allow OPDP to review direct-to-consumer (DTC) and health professional advertising more effectively."
