"We plan to submit comments to ensure the final guidance is fair, clear and can be implemented by those it impacts."
The Food and Drug Administration (FDA) has opened a comment period regarding the newly released draft guidance for the Adverse Event Reporting (AER) law. The Natural Products Association today issued the following statement by Daniel Fabricant, Ph.D., vice president of scientific and regulatory affairs, in response to the draft guidance and comment period:
“The FDA has worked diligently to meet the mandated statutory requirement to issue guidance to implement the AER legislation. As the largest trade association representing both retailers and manufacturers, we plan to submit comments on the draft to ensure that the final guidance is fair, clear and can be implemented by those it impacts.”
The draft guidance addresses the major provisions of the AER act, specifically providing some greater detail on reporting responsibilities as put forth in the draft guidance. The draft guidance offers an appendix with some detailed instruction for the “manufacturer, packer, or distributor” on how to best complete the 3500A form with the necessary information for compliance. This process was and remains an area of concern, as how to best use the 3500A form to submit AER's for dietary supplements. The 3500A was originally designed for surveillance in a clinical setting, but is now to be used and adapted to gather information on consumer health products in the marketplace.
The guidance also elaborates and offers some clarification on the use of agreements between retailers and manufacturers to transfer the responsibility for submitting adverse event reports for the product to the manufacturer. Additionally, the guidance states that when submitting a report to FDA, “…a copy of the label on or within the retail packaging of that dietary supplement must be included with the serious adverse event report to FDA” and that the agency encourages the responsible person to attach any relevant clinical, laboratory or other critical data with the 3500A form.
Comments to the agency are due December 14, 2007. The draft guidance and instructions for submitting comments are available at http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0388-gdl0001.pdf.