The Council for Responsible Nutrition (CRN), Washington, D.C., has submitted comments to the FDA regarding the agency’s estimated burden associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA), published in the Federal Register on March 23, 2012.
In the Federal Register Notice, FDA estimated the annual reporting and recordkeeping burden to the industry based on FDA’s experience with similar adverse event reporting programs. The estimated burden includes:
• An average of 2 hours per report to collect information about a serious adverse event associated with a dietary supplement and report the information to FDA on MedWatch Form FDA 3500A;
• One hour to assemble and submit any follow up reports of new medical information regarding the serious adverse event report, as recommended in the guidance;
• Thirty minutes to assemble and file these records internally as part of the mandatory recordkeeping requirement.
According to CRN, “In order for the industry to effectively satisfy the obligation of reporting serious adverse events received, all reports, including those for non-serious adverse events, must be evaluated. Initial reports of adverse events require thorough investigation in order to accurately determine whether the event is serious or non-serious. For example, some reports may include symptoms that may or may not clearly qualify the report as a serious adverse event report. This requires interpretation of the medical evidence by qualified experts. CRN member companies frequently use third parties, such as medical experts, to review adverse events in order to obtain thorough, unbiased and qualified medical opinions, as necessary. These additional steps increase the total time and cost associated with collecting information on all adverse events and reporting serious adverse events. Based on CRN members’ experience, the number of hours it takes to collect and report serious adverse events falls within 2-10 hours per report.”