The American Herbal Products Association (AHPA) announced recently that its comments to the US Food and Drug Administration (FDA) concerning the agency's ruling on serious adverse event reporting (SAER) and recordkeeping for dietary supplements apparently were heeded.
When the FDA issued its draft guidance on this topic in October 2007, the AHPA filed comments supporting the agency's thinking on some details and asking for clarification on others. AHPA says that in the agency's most recent document, "Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act," the FDA addressed each of the topics for which the association requested revisions.
AHPA cited several examples, among them: "The Act defines an SAER to include, among other things, 'inpatient hospitalization.' AHPA commented that the draft's description of inpatient hospitalization could be misinterpreted such that 'the act of seeking treatment at a hospital emergency room for a minor adverse event could be erroneously considered to be a serious adverse event.' AHPA also noted that the mandatory MedWatch Form 3500 provides additional information that would prevent any such confusion. The final guidance now provides an appendix which links to the MedWatch instructions, and so states that 'emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes.' This language clarifies that an emergency room visit does not necessarily and in and of itself constitute inpatient hospitalization."
The association also disagreed with the FDA's position on forwarding erroneously submitted reports to "that other responsible person." AHPA suggested that this language be revised both to acknowledge that there is no requirement under the act to do anything with such a report, and to replace the words 'should be promptly forwarded' with 'the agency recommends that such reports be promptly forwarded.' In the final guidance, this suggestion was included almost verbatim.
The FDA also recommended that companies responsible for submitting SAERs "use trained health care practitioners to elicit information from reporters." AHPA disagreed, suggesting that this be described as only one of several options for obtaining such essential information. The FDA subsequently clarified that use of practitioners is just one of the means that can be used to achieve this purpose.
AHPA is an association of domestic and foreign growers, processors, manufacturers and marketers of herbs and herbal products. Its formal comments on the FDA's original report are available at http://www.ahpa.org/Portals/0/pdfs/07_1214_AHPAcomments_DS-SAER.pdf.
The FDA's guidance is available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm171383.htm