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U.S. Department of Health and Human Services

Science & Research

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MedWatchPlus / FAERS

The Food and Drug Administration is currently developing an electronic system for receiving, processing, evaluating, and analyzing adverse event reports and other safety information for all FDA-regulated products.  This new system, MedWatchPlus, provides a single point of entry for reporters, will enhance the current MedWatch program to include submission of reports for all FDA regulated products and combine the Agency's various safety reporting processes and systems, and FAERS (FDA Adverse Event Reporting System), will be the FDA’s new repository and enhanced analytic methods to enable staff to efficiently analyze thousands of safety reports and identify potential safety problems. 

Operations for submitting electronic reports through the FDA Electronic Submissions Gateway (ESG) will continue for reporters that have established agreements with FDA.

The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are working together to develop a public Web site and data collection tools that will let anyone report safety problems concerning drugs and medical devices, even if these events were experienced during a clinical trial. The Web site also will accept reports on safety problems with food, animal feed, veterinary products, and other FDA-regulated products.

The collaboration between FDA and NIH is building on two other federal programs.  One, FDA’s MedWatch program, enables people to report safety problems pertaining to some FDA-regulated products (drugs, biologics, devices, or dietary supplements).   FDA is expanding the MedWatch program to include safety reports for all FDA-regulated products (MedWatchPlus). The other program is the Federal Adverse Event Task Force (FAET), which is working to simplify and harmonize the federal reporting of adverse events that occur during clinical trials.  FAET is a joint effort involving several agencies that conduct or oversee clinical trials, including FDA, NIH, the Office of Human Research Protections, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, the Department of Defense, and the Agency for Healthcare Research and Quality.  In commenting on this project, Dr. Amy Patterson, Acting Director for Science Policy, Office of the Director, NIH, said that “This effort will enable research investigators to enter clinical trial adverse event data once and forward the standardized report directly to allthe appropriate federal oversight agencies or organizations in a single, expedited process.”

The Web site will include software called a “rational questionnaire” that will ask users simple questions to help them determine what information they should provide.  The system will compile the users’ responses into a standardized report that can be used across multiple agencies.  Once MedWatchPlus has been implemented, anyone with Internet access will be able to report a safety concern about a medical product as well as foods, cosmetics, animal feed, and veterinary products.  For example:

  • A healthcare provider could report an unexpected event associated with the use of a drug.
  • A researcher could report a problem with a drug being tested in a clinical trial.
  • A consumer could report a concern about a drug they are taking at home, or about a food that might have made them ill. 
  • A pet owner could report an event associated with the use of an animal drug or ingestion of pet food.
  • A medical device manufacturer could report an injury caused by a defective product.

The MedWatchPlus Portal and FAERS data system will be made available in stages.  Implementation activities for the first software release, such as working with early adopters from the various constituent groups, will begin in the late spring and summer of 2009.  At that time, reporters will be able to use the Internet to access the MedWatchPlus Portal to report safety concerns about reportable food events, animal drugs, and pet food, thus fulfilling the mandatory reporting requirements of the Food and Drug Administration Amendments Act of 2007.  The early adopters will assist in refining the Portal in preparation for its full launch.  A series of second staged releases, with implementation activities expected to begin in late 2009 through 2010, will involve the integration of existing electronic reporting systems for additional human food products/incidents, as well as drugs, devices, and biological products. The third release in 2011 will integrate remaining reporting systems not included in the prior releases, e.g. Office of Regulatory Affairs product problem and complaint reports.  “For the first time, we will be able to collect and track safety information from virtually anyone who touches a particular FDA product throughout its life cycle—from manufacturing through initial marketing to its wide-spread use,” explained Dr. Rachel Behrman, FDA Associate Commissioner for Clinical Programs/ Director, Office of Critical Path Programs, the office supporting the effort.  “This will be a key component in an improved, nationwide surveillance system that will strengthen our ability to protect the Nation’s public health.”

With all of this safety information going into the new FAERS in a consistent and complete fashion, FDA staff will be able to systematically analyze data and determine the number of reports that detect a particular problem, such as allergic reactions or heart attacks, and how frequently a problem is occurring.  They also will be able to determine whether certain groups of people—young children, or people in a particular geographic area—are experiencing the problem more frequently than others. 

Currently, conducting these types of analyses is slow and difficult work because many of the FDA’s systems for tracking safety reports are more than 10 years old, and they lack the analytic capabilities that are commonplace today.  Presently, each FDA center maintains its own separate computer system to track adverse event and safety information about its specific products. The systems are not linked, making combination product analyses very difficult.  Also, until recently, safety reports about dietary supplements, human food and pet food have been voluntary only, and those reports that are submitted come in a variety of ways, including by phone, fax, or mail. The new MedWatchPlus system and FAERS data repository will make reporting easier, facilitate the receipt of consistent and complete information, and consolidate reports from all sources into a unified database where they can be efficiently analyzed and addressed.