The Office of Surveillance and Epidemiology monitors and evaluates the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of the drugs. OSE maintains a system of postmarketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug development process. OSE evaluates more than 1.5 million adverse event reports submitted every year to FDA's MedWatch program. Staff in the Office of Surveillance and Epidemiology use this information to identify drug safety concerns and recommend actions to improve product safety and protect the public health.
The Office of Surveillance and Epidemiology consists of Six divisions:
- Office of Pharmacovigilance and Epidemiology
- Division of Pharmacovigilance I
- Division of Pharmacovigilance II
- Division of Epidemiology I
- Division of Epidemiology II
- Office of Medication Error Prevention and Risk Management
- Division of Medication Error Prevention and Analysis
- Division of Risk Management
Office of Pharmacovigilance and Epidemiology (OPE)
Division of Pharmacovigilance (DPV I & DPV II)
Safety Evaluators and Medical Officers in DPV-I and DPV-II detect safety signals and assess safety-related issues for all marketed drug and therapeutic biologic products. They use a variety of surveillance tools including adverse event report data, published scientific literature, and preclinical, clinical, and pharmacologic knowledge of the products to provide scientific and clinical evaluation that leads to various regulatory actions and communications for safe use of the marketed products.
Division of Epidemiology (DEPI I & DEPI II)
Our epidemiologists conduct active drug safety surveillance using the Sentinel System, conduct epidemiologic studies using observational data resources, and review drug safety-related epidemiologic study protocols and study reports that are required of manufacturers as post marketing requirements (PMRs) and commitments (PMCs). They serve as the Agency lead in ensuring that the observational post marketing studies conducted by sponsors meet the best practices in epidemiology and can provide robust and actionable evidence to inform regulatory decision making following initial approval. They evaluate safety signals that arise by putting them into the context of drug use including calculating reporting rates, the existing body of evidence in the scientific literature, and by mounting FDA-sponsored epidemiologic studies as needed to quantify and characterize drug safety risks detected through spontaneous reports or through systematic review of the scientific literature. They serve as subject matter experts for the observational data aspects of the use of real world evidence. They also provide data that aid in increasing the FDA's ability to request regulatory impact studies such as those authorized under Best Pharmaceuticals for Children Act (BPCA).
Drug Utilization Analysis Staff
Our Drug Use Analysts procure, manage and analyze pharmaceutical sales and health care data to describe and characterize drug utilization levels and treatment patterns in the US to support regulatory decision-making in FDA/CDER. The staff maintains an expertise in pharmacy practice, health care delivery, and pharmacoepidemiology principles to evaluate and interpret these data. They also actively research the market for new resources to address unmet needs in understanding the use of medical products in various settings of care. This allows us to provide drug utilization data as a context for drug safety issues, as well as for supporting evaluation of Risk Evaluation and Mitigation Strategies (REMS) and the impact of FDA regulatory actions.
Office of Medication Error Prevention and Risk Management (OMEPRM)
Division of Medication Error Prevention and Analysis (DMEPA)
Mission: Increase the safe use of drug products by minimizing use error that is related to the naming, labeling, packaging, or design of drug products regulated by the Center for Drug Evaluation and Research (CDER).
Vision: To eliminate medication errors in the U.S. healthcare system. As part of the FDA preapproval process for new drug products, we review proposed proprietary drug names, container labels and other labeling, packaging, product design, and human factors protocols and study results to prevent medication errors. We also monitor and analyze medication error reports for marketed products to determine if regulatory actions such as labeling revisions or product redesign are needed to address reported errors. We collaborate with external stakeholders, regulators, and researchers to understand the causes of medication errors and the effectiveness of interventions to prevent them, and provide guidance to industry on drug development considerations to prevent medication errors.
Division of Risk Management (DRISK)
DRISK serves as the focal point for risk management activities in CDER. DRISK provides risk management expertise on development and implementation of programs and initiatives to support the Center’s policies related to Risk Evaluation and Mitigation Strategies (REMS) authorities under the Food and Drug Administration Amendments Act (FDAAA) of 2007. DRISK reviews all proposed REMS, REMS modifications, and REMS assessments for all products with approved REMS for conformance with current FDA standards.