Day Alert Reports

Applicants and licensed manufacturers must submit a ''15-day Alert report'' for each domestic or foreign adverse product experience that is both ''serious'' and ''unexpected'' to the FDA within 15 calendar days of the receipt of information about the experience. 21 C.F.R. §§ 310.305(d), 314.80(c)(1)(i), 600.80(c)(1)(i).

The definition of ''serious'' for post-marketing adverse product experiences is identical to that for IND adverse product experiences discussed above. 21 C.FR. §§ 310.305(b), 314.80(a), 314.98, 600.80(a).

The definition of''unexpected'' for post-marketing adverse product experiences is similar to that for the IND adverse product experiences. An adverse product experience is ''unexpected'' if the experience is not listed in the current labeling for that product. 21 C.F.R. §§ 310.305(b), 314.80(a), 314.98, 600.80(a). An adverse product experience is ''unexpected'' even if it could have been anticipated from the pharmacological properties of the product so long as it is not listed in the labeling. Id. This definition includes events that are symptomatically and pathophysiologically related to events listed in the labeling, but differ due to greater severity or specificity. Id. As an example of an event that is ''unexpected'' due to greater severity, the regulations cite hepatic necrosis when the labeling refers only to elevated hepatic enzymes or hepatitis. See id. As an example of an event that is ''unexpected'' due to greater specificity, the regulations cite cerebral thromboembolism and cerebral vasculitis when the labeling refers only to cerebral vascular accidents. Id.

Unlike the expedited reporting of adverse events to the INDs, spontaneous post-marketing events do not require an assessment of causality. It is the FDA's view that when a report is spontaneously made regarding a drug, there is implied causality, because the reporter would otherwise not have taken the time to transmit the information to the applicant or a regulatory authority.

15-day Alert Report Follow-Ups

Applicants or licensed manufacturers also are required to perform promptly a ''follow-up''

investigation into the adverse product experience and separately to report any new information to the FDA as a "15-day Alert report follow-up'' within 15 calendar days of the receipt of that information. 21 C.F.R. §§ 310.305(c)(2), 314.80(c)(1)(ii), 314.98, 600.80(c)(1)(ii). If the applicant or licensed manufacturer performs an investigation but is unable to uncover any additional information, then the applicant or licensed manufacturer should maintain records of the steps taken but need not submit a follow-up report. Id.

15-day Alert Reports Based on Scientific Literature

Fifteen-day Alert reports must be filed when "serious" or "unexpected" adverse product experiences are reported in case reports or in the results of formal clinical trials published in scientific or medical journals. 21 C.F.R. §§ 314.80(d), 314.98, 600.80(d). When a 15-day Alert report is based on information obtained from scientific or medical journals, a copy of the article must be included with the report. Id.

Exceptions to the 15-day Alert Report Requirements

No 15-day Alert report is required for information regarding an adverse product experience that was obtained from a post-marketing study, including those conducted under an IND application, unless the applicant or licensed manufacturer concludes that there is a ''reasonable possibility" that the product caused the experience. 21 C.F.R. §§ 310.305(c)(1)(ii), 314.80(e), 314.98, 600.80(e). When reports of adverse product experiences obtained during a post-marketing study are reported in any context, they should be marked to indicate that they were so obtained. Id.

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