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  1. Surveillance: Post Drug-Approval Activities

Postmarketing Surveillance Programs

Despite CDER's vigilant premarket review, active postmarketing surveillance of drug adverse effects is also essential. Because all possible side effects of a drug can't be anticipated based on preapproval studies involving only several hundred to several thousand patients, FDA maintains a system of postmarketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug approval process. FDA monitors adverse events such as adverse reactions and poisonings. The Agency uses this information to update drug labeling, and, on rare occasions, to reevaluate the approval or marketing decision. 

This page describes how CDER works to assure the ongoing safety and effectiveness of drug products currently marketed in the United States.

The FDA Adverse Event Reporting System (FAERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The ultimate goal of FAERS is to improve the public health by providing the best available tools for storing and analyzing safety reports. The reports in FAERS are evaluated by a multidisciplinary staff safety evaluators, epidemiologists and other scientists in the Center for Drug Evaluation and Research's (CDER) Office of Surveillance and Epidemiology to detect safety signals and to monitor drug safety. As a result, the FDA may take regulatory actions to improve product safety and protect the public health, such as updating a product's labeling information, sending out a "Dear Health Care Professional" letter, or re-evaluating an approval decision.

The MedWatch program is for health professionals and the public to voluntarily report serious reactions and problems with medical products, such as drugs and medical devices. It also ensures that new safety information is rapidly communicated to the medical community thereby improving patient care. All data contained on the MedWatch form will be entered into the AERS database. The MedWatch page includes sections on how to report an adverse event, safety information, and publications. For more information on how to report adverse events, see Reporting Problems to FDA.

The Division of Drug Marketing, Advertising and Communications page also contains other useful drug advertising and surveillance information.

After a drug is approved and marketed, the FDA uses different mechanisms to assure that firms 1) adhere to the terms and conditions of approval described in the application and 2) that the drug is manufactured in a consistent and controlled manner. This is done by periodic, unannounced inspections of drug production and control facilities by FDA's field investigators and analysts.

Manufacturers of prescription medical products are required by regulation to submit adverse event reports to the FDA. The MedWatch site provides information on mandatory reporting by manufacturers. In addition, drug manufacturers must submit either error and accident reports or drug quality reports when deviation from current good manufacturing practice regulations occur.

 FDA receives medication error reports on marketed human drugs (including prescription drugs, generic drugs, and over-the-counter drugs) and nonvaccine biological products and devices. The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use." CDER medication errors program staff review medication error reports sent to the USP-ISMP Medication Errors Reporting Program and MedWatch, evaluate causality, and analyze the data to provide feedback to others at FDA.

Drug Shortages. It is FDA's policy to attempt to prevent or alleviate shortages of medically necessary products. Drug shortages may arise from varying causes, such as the unavailability of raw materials or packaging components, marketing decisions, and enforcement issues. See the MaPP on Drug Shortage Management (PDF - 78KB) for an overview of CDER's drug shortage management responsibilities, and how drug shortage reports are processed.

Therapeutic Inequivalence Reporting. In the past 10 years, FDA's Center for Drug Evaluation and Research has received an increase of reports of drug products that fail to work in patients because the product simply has no effect or is toxic. These problems are usually attributed to switching brands of drugs. As a result, on Sept. 14, 1988, FDA created in CDER the Therapeutic Inequivalence Action Coordinating Committee (TIACC) to identify and evaluate reports of therapeutic failures and toxicity that could indicate that one product is not equivalent to another similar product

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