Pharmacoepidemiology Efforts

CDER's Division of Pharmacovigilance and Epidemiology (DPE) also carries out an epidemiological function in the monitoring of drug safety. This function is performed by a multi-disciplinary professional staff of physicians and Ph.D. epidemiologists, pharmacists and program/project managers. The primary work is directed towards the evaluation and risk assessment of drugs in the postmarketing environment, using the tools of epidemiology.

Epidemiologists integrate the medical/clinical details of the underlying disease being treated with the influence of patient factors, concomitant diseases and medications, as well as the clinical pharmacology of the specific product under study.

DPE's Epidemiology staff work closely with the Post-Marketing Safety Reviewers to provide clinical and epidemiologic case-series reviews of spontaneous adverse event reports submitted to FDA. These data are used in a variety of ways to develop and further refine and investigate signals of clinical importance related to drug safety. As a complement, drug-use data are used frequently to estimate the size and characterize the demographic composition of the population exposed to a given prescription product.

Additionally, epidemiologists are involved in the design and critique of Phase IV protocols for safety studies performed by industry, and in the review of study findings. They also design, execute and help to analyze data from epidemiologic studies performed through the mechanism of the DPE's cooperative agreement program which provides the Center with access to several large record-linked databases.

The reports produced by DES are integral to the ongoing risk assessment and risk management performed by CDER review divisions of a product’s risk vs. benefit profile . In addition, DPE epidemiologists are called upon to meet with industry over important safety issues or to present their work before FDA advisory committees.