Drug Reaction Injury Attorneys

What Is the FDA Adverse Reporting System?

The FDA adverse event reporting system is a part of the FDA's MedWatch program designed to notify the administration of after-market problems caused by drugs, nutritional supplements and other products covered under FDA regulations. The Center for Drug Evaluation and Research oversees the adverse event reporting system.

What Does the Reporting System Cover?

The adverse reporting system put in place by the FDA does not cover all products. According to FDA regulations, the reporting system reports serious adverse effects caused by products regulated by the FDA, such as:

• Cosmetics
• Biologic products, like tissue, blood products and other bio-molecular products, excepting vaccines
• FDA-regulated drugs, but not alcohol or illegal drugs
• Medical devices
• Nutritional products

What Are the Types of Adverse Event Reports?

Adverse event reports have two types: a voluntary report produced by healthcare professionals, consumers and patients; and a mandatory report produced by importers, distributors and manufacturers. These two adverse event reports use separate forms.

1. Form FDA 3500 Online Voluntary Report Form

   Form FDA 3500 is available online by consumers, healthcare professionals and patients. Although the FDA does oversee vaccines, adverse reactions involving vaccines are reported on a different form, the VAERS-1.

2. Form FDA 3500A for Mandatory Reporting

   The FDA uses a different form to handle mandatory reporting of adverse events made by importers, distributors and manufacturers. Unlike the voluntary event report, a hard copy of this form must be mailed to the appropriate FDA office. Drug reports generally go to the Center for Drug Evaluation and Research. Biological products and medical device reports are sent to the Center for Biologics Evaluation and Research or the Center for Devices and Radiological Health, respectively.

What Does the FDA Do with Event Reports?

The FDA gathers all adverse event reports in a national database. This database updates quarterly with drug information, drug reactions, patient outcomes and other information. The information in the database is available to the public.

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