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Adverse Event Reporting for Pharmaceutical Products
The Food and Drug Administration (FDA) provides some protection to drug companies regarding adverse event reports by allowing a disclaimer statement about liability. However, this is not a blanket defense against other potential liability exposure.
According to the FDA's regulations, drug companies with approved marketing applications must report certain types of adverse drug experiences or adverse events (AEs), depending on the nature of the facts and within specific periods of times. 21 C.F.R. ' 314.80. The FDA defines “adverse drug experience” as “any adverse event associated with the use of a drug in humans, whether or not considered drug related ' .” 21 C.F.R. ' 314.80(a). However, the FDA recognized that companies would be reluctant to disclose such AE information for fear of government prosecution or potential liability concerns. Therefore, the agency provides:
A report or information submitted by an applicant under this section (and any release by FDA of that report or information) does not necessarily reflect a conclusion by the applicant or FDA that the report or information constitutes an admission that the drug caused or contributed to an adverse event. An applicant need not admit and may deny, that the report or information submitted under this section constitutes an admission that the drug caused or contributed to an adverse effect ' .
21 C.F.R. ' 314.80(k).
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