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 Sentinel’s ARIA system (Active Risk Identification and Analysis), and .review drug safety-related epidemiologic study protocols and study reports that are required of manufacturers as post marketing requirements (PMRs) and commitments. They serve as the Agency lead in ensuring that the PMRs 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, 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. In addition, our drug utilization team provides denominator data, or context, for understanding adverse event reports; for modeling drug risk based on usage patterns; and for calculating patient-based reporting rates. 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) to better understand the usefulness of drug labeling to clinicians.
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)
DMEPA is primarily responsible for the premarket review of proposed proprietary medication names, labels/labeling, packaging, and Human Factor Studies in order to reduce the potential for medication errors for CDER-regulated products. DMEPA also conducts review and analysis of post-marketing medication errors submitted to CDER to determine if regulatory actions are needed such as label /labeling revisions, product redesign, or post-marketing communications to stakeholders. DMEPA works with external stakeholders, regulators, and researchers to better understand the causes of medication errors and the effectiveness of interventions at preventing them, and provides guidance to industry on drug development considerations from a medication errors perspective.
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.