The FDA published updated guidelines for dietary supplement
manufacturers, distributors and sellers outlining
their obligations to report serious adverse reactions (SAEs)
regarding their products to the federal government. Rumberger
Kirk & Caldwell attorney Dan Gerber discusses the reporting
requirements and what manufacturers can do to ensure that they are
The FDA defines an SAE as "a complication that results in
death, a life-threatening experience, inpatient hospitalization, a
persistent or significant disability or incapacity, or a congenital
anomaly or birth defect; or requires, based on a reasonable medical
judgment, a medical or surgical intervention to prevent an outcome
Being diligent in reporting for one thing. Also,
understanding that it gets tricky real fast if the doctor or a
family member reports something and you (the manufacturer) do
not. Also, regular auditing occurs to ensure that
manufacturers are compliant.
They should work with trade groups and legal counsel to
determine when a warning should be included and the strength of the
warning. Also, being diligent in investigating SAERs can help
signal whether additional reporting is required.
A manufacturer's insurance policy language governs whether
an SAER should be reported or not. The purpose for an SAER is
not for a person to make a claim, so the most logical solution
under most insurance policies would be that no claim reporting is
required to the insurance carrier. However, given that
Congress specified that these are not admissible and are often only
anecdotal and rarely lead to a reportable claim.
Dietary supplement manufacturers must be aware that
insurers may request SAER filings or summaries before one is bound
within an insurance agreement. You cannot avoid the SAER duty
simply because you are concerned it may affect your insurance
coverage. However, you should be aware that excessive SAER filings
may result in higher insurance coverage or no coverage at all.
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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