In a letter to the Division of Dockets Management, Taylor Wallace, PhD, Senior Director, Scientific & Regulatory Affairs for CRN and Douglas MacKay, ND, vice president, Scientific & Regulatory Affairs for CRN state that the Council’s members have shown that AER incur capital costs associated with software, staff training, re-training, and third party experts used to stay in compliance with the law.
Adverse event reporting (AER) and recordkeeping for dietary supplements are required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA).
According to the FDA’s position, there are no costs associated with the reporting, a position that CRN is challenging. In addition, FDA has estimated that each report will take an average of two hours, in addition to one hour to assemble and submit any follow up reports and thirty minutes to assemble and file these records internally as part of the mandatory recordkeeping requirement, giving a total time commitment of 3.5 hours.
“However, this estimate should be presented as a range of 2-10 hours as each individual case may vary considerably,” wrote Dr Wallace and Dr MacKay. “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.”
CRN also maintains that companies spend a lot of time maintaining non-serious adverse event reports, which are “more frequently reported and therefore account for the majority of the time spent as part of the mandatory recordkeeping requirement”.
Please click here to read the full letter.