The Office of Surveillance and Epidemiology (OSE) 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 and evaluate adverse events and medication errors that did not appear during the drug development process. OSE evaluates more than 2 million adverse event and medication error reports submitted every year to FDA's MedWatch program. Staff in OSE use this information to identify drug safety concerns and recommend actions to improve product safety and protect the public health. OSE also supports the Center’s policies related to Risk Evaluation and Mitigation Strategies (REMS) authorities under the Food and Drug Administration Amendments Act (FDAAA) of 2007.
The Office of Surveillance and Epidemiology consists of eight 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 I
- Division of Medication Error Prevention and Analysis II
- Division of Risk Management
- Division of Mitigation Assessment and Medication Error Surveillance
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)
The OMEPRM mission is to increase the safe use of drug products and improve public health by minimizing use error that is related to the naming, labeling, packaging, or design of drug products, and developing effective and efficient Risk Evaluation and Mitigation Strategies (REMS) for certain drug products that ensure the benefits outweigh its risks.
Division of Medication Error Prevention and Analysis (DMEPA I & DMEPA II)
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 submissions to prevent medication errors. We also review medication error reports submitted to the FDA Adverse Event Reporting System (FAERS) and work collaboratively with the Division of Mitigation Assessment and Medication Error Surveillance to investigate and determine if regulatory actions such as labeling revisions or product redesign are needed to address reported errors. We also 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 (DRM)
DRM serves as the focal point for risk management activities in CDER. DRM provides risk management expertise on design, 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. DRM provides input on the need for a REMS for all new molecular entities (NMEs), original BLAs, and post approval for serious risks that warrant consideration of a REMS. Additionally, DRM reviews sponsor-proposed REMS and REMS modifications for all products with an approved REMS for conformance with current FDA standards. REMS decision-making is a joint decision between the Office of Surveillance and Epidemiology (OSE) and the Office of New Drugs. DRM serves as the REMS experts within OSE and the scientific lead for CDER on all new REMS and REMS modifications. In conjunction with the Division of Mitigation Assessment and Medication Error Surveillance (DMAMES) and Office of New Drugs, DRM participates in the review of REMS assessment reports. DRM consists of healthcare professionals with varied backgrounds, including: pharmacists, physicians, nurses, and health communication specialists.
Division of Mitigation Assessment and Medication Error Surveillance (DMAMES)
DMAMES provides expertise to evaluate risk mitigation strategies and recommend regulatory actions to ensure safe and effective use of drug products. Our focus is on identifying and mitigating medication errors and assessing Risk Mitigation and Evaluation Strategies (REMS) for marketed products. We are the lead for medication error pharmacovigilance, and collaboratively work on safety signal detection, assessment, understanding, and prevention of medication errors. We also collaboratively review proposed new REMS and REMS modifications, REMS assessment methodologies, and REMS assessment reports. We develop standards, policies, and approaches related to health informatics and data management tools and techniques to support REMS standardization and integration initiatives, medication error prevention and analysis, use of structured product labeling, and electronic health record interoperability. We also work closely with other entities, including the Institute for Safe Medication Practices (ISMP), to support research and innovation to advance the science of risk assessment and mitigation and protect public health.