Office of Drug Safety Divisions

In 2002, the Office of Post-marketing Drug Risk Assessment (OPDRA) was renamed the Office of Drug Safety (ODS), and is now located under a new super office, the Office of Pharmacoepidemiology and Statistical Science (OPaSS). The Office of Drug Safety has gained the MedWatch program, formerly with the Office of Training and Communications, and patient labeling and risk communication functions, formerly with the Division of Drug Marketing, Advertising, and Communications. 

ODS will be involved in many Center initiatives dealing with risk management. These will include the development of a Risk Management White Paper, the identification of a risk management and risk communication research agenda and the launch and utilization of the new Drug Safety and Risk Management Advisory Advisory Committee. This new advisory committee is comprised of nationally recognized experts in the areas of risk perception, risk management, pharmacoepidemiology, clinical pharmacology, clinical research, and medication errors. They will advise FDA on both general and product-specific safety issues.

ODS has three divisions.

Division of Drug Risk Evaluation (DDRE)

DDRE staff includes safety evaluators whose primary role is to detect and assess safety signals for all marketed drug products. They work closely with medical reviewers in the Office of New Drugs so that potential safety signals are placed in the context of existing preclinical, clinical, or pharmacologic knowledge of the drugs in question.

Our epidemiologists review epidemiologic study protocols that are increasingly required of manufacturers as phase four commitments. They evaluate various postmarketing surveillance tools that may be incorporated into risk management strategies, such as patient registries and restricted distribution systems. They estimate the public health impact of safety signals by evaluating computerized databases and the published literature. 

Division of Medication Errors and Technical Support (DMETS)

DMETS primarily provides pre-marketing reviews of all proprietary names, labels and labeling in CDER in order to reduce the medication error potential of a proposed product. DMETS also provides post-marketing review and analysis of all medication errors CDER receives. 

Division of Surveillance, Research, and Communication Support (SRCS)

SRCS is a newly formed division that  handles data resources, risk communication, and outcomes and effectiveness research components of drug safety risk management programs. This Division oversees MedWatch, risk communication research and activities such as Medications Guides, Patient Packet Inserts, and pharmacy information surveys, and international regulatory liaison activities (such as videoconferencing) for all drug and biologic postmarketing safety issues. SRCS also manages the expansion in the use and number of ODS safety and epidemiologic data resources.