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DRAFT 1.2.2 - released for comment 10/09/07
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For Commercial Users and Associate Members A Project of the Institute for Health Research
AER Screening Guide & Procedures DRAFT 1.2.2 (10/12/07)
AERC (Adverse Event Reporting Consultants) is a public service project of the Institute for Health Research. This Guide is intended as an interim guidance under the Dietary Supplement and Non-Prescription Drug Consumer Protection Act. AERC will screen and evaluate reported Adverse Events; providing a facility to report "serious" Adverse Events, as required by the law. It will not be expected to determine responsibility or corrective action and will be limited to a standard of reasonable care in determining if the allegations meet the serious requirement for reporting to the FDA. In the event FDA issues final Regulations implementing the law, those Regulations will supersede this Guide where the Guide is inconsistent therewith. It is intended that this Guide will be modeled on any final FDA Guidance document issued regarding Adverse Event Reporting.
Determination of "Serious Adverse Event" Status: if the nature of the alleged "event... that is adverse" may come within the statutory harm definition, it will require professional review to determine whether it meets the serious threshold. There is an additional minimum expense of $150 (cost will be estimated before services are provided, based on the number of experts needed, additional investigation and length of report, including alternative explanations). Associates will have an opportunity to choose minimum review. Serious Adverse Event Report: If the report does rise to the level of a serious adverse event report, the standard report will be completed and submitted to the FDA on behalf of the Associate with all appropriate alternative explanations (such as customer use not as directed and drug interference with the nutrient) expense, $200.
C.
Initial Screening Questions [Draft]
Top D. Further requirements to determine if an Adverse Event meets the "serious event" test 1. Company to provide batch records and control tests for suspect product; indemnify and hold AER Consultants harmless.
2. Customer to
Provide copies of medical, insurance or other professional reports relating to
the alleged adverse event. "The undersigned customer making the above adverse event report hereby consents to the release of all medical and personal records to AER Consultants, to be reviewed privately and hereby permits access to HIPPA records for the purposes of the review of the alleged adverse event. Customer hereby releases AER Consultants of all liability for providing review services."
Official Text of Act: http://www.fda.gov/cder/regulatory/public_law_109462.pdf (a) Definitions- In this section:
`(1)
ADVERSE EVENT - The term `adverse event' means any health-related event
associated with the use of a dietary supplement that is adverse.
`(2)
SERIOUS ADVERSE EVENT - The term `serious adverse event' is an adverse event
that--
`(A)
results in--
`(i)
death;
`(ii)
a life-threatening experience;
`(iii)
inpatient hospitalization;
`(iv)
a persistent or significant disability or incapacity; or
`(v)
a congenital anomaly or birth defect; or
`(B)
requires, based on reasonable medical judgment, a medical or surgical
intervention to prevent an outcome described under subparagraph (A).
`(3) SERIOUS ADVERSE EVENT REPORT -
The term `serious adverse event report' means a report that is required to be submitted to the Secretary under subsection (b). © 2007 IHR |
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