The DSNDCPA (Public Law 109-462, 120 Stat. 3469) amends the Federal Food, Drug, and Cosmetic Act (FDCA) to require a manufacturer, packer, or distributor of a dietary supplement to (1) submit to FDA all serious adverse events associated with the use of a dietary supplement, along with a copy of the product label; (2) any related new medical information received within one year of the initial report; and, (3) the maintenance of records related to any dietary supplement adverse event received, whether or not the adverse event is serious, which must be retained for at least 6 years [FDCA Section 761 (b)- (e), 21 U.S.C. 379 (b)-(e)]. Subsequent guidance issued by FDA provided further recommendations regarding the minimum data elements for adverse event reports and additional information that should be collected when an adverse event report is received (74 FR 34024).
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 fall within 2-10 hours per report.
“In addition, many CRN members have invested significant capital resources in robust systems for capturing post-market surveillance data such as adverse events reports. For example, there are systems that enable manufacturers to monitor adverse events globally so signals can be detected and intervention can occur at the earliest stage possible. The type of system a company has in place for receiving, investigating, reporting, and storing adverse events, as well as human resource capacity, clearly impacts the amount of time spent on each report. CRN disagrees with FDA’s position that there are no capital costs or operating and maintenance costs associated with adverse event reporting and recordkeeping for dietary supplements as required by the DSNDCPA. There are capital costs associated with software, staff training, re-training, and third party experts used to stay in compliance with the law.
“In addition, the Notice does not account for the time invested in maintaining non-serious adverse event reports, as required under Section 761(e)(1) of the FDCA (21 U.S.C. 379aa-1(e)(1)) and specified in the Agency’s guidance document. Non-serious adverse events are more frequently reported and therefore account for the majority of the time spent as part of the mandatory recordkeeping requirement.
“In conclusion, CRN believes that the Agency’s estimate of 3.5 hours (total, per report) for accurately reporting and maintaining records of a serious adverse event may be correct in some instances. However, this estimate should be presented as a range of 2-10 hours as each individual case may vary considerably. This range is consistent with the estimates provided by CRN members and takes into account the need to thoroughly investigate and evaluate all reports to determine whether they are serious or non-serious, as well as the maintenance of reports. FDA should also consider the significant capital costs associated with robust monitoring and accurate reporting of serious adverse events.”