Adverse Event Reporting for Pharmaceutical Products

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).

In the preamble to the final regulation, the agency said that the disclaimer is consistent with the Medical Device Reporting regulations. 50 Fed. Reg. 7452, 7476 (Feb. 22, 1983). However, the disclaimer is only an FDA protection; it does not protect companies from potential product lawsuits. In fact, the agency said that, although the FDA does not intend for such a report to be viewed as an admission of liability, whether a court will treat a submission to the FDA as an admission will depend on factors outside of the agency's control, such as the contents of the report itself. 50 Fed. Reg. at 7476; see also FDA, Center for Drug Evaluation and Research, Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (Mar. 2005). available at www.fda.gov/downloads/regulatoryinformation/guidances/ucm126834.pdf. Consequently, achieving the correct scope and substance in the AE report is a formidable task.