CRN Submits AER Comments to FDA, Says Agency Underestimates Time, Cost

May 22, 2012

CRN estimates each AER may take between 2 to 10 hours per report.

In draft guidance comments to FDA regarding adverse event reporting (AER), the Council for Responsible Nutrition (CRN; Washington, DC) says that FDA underestimates both time and capital costs to dietary supplement companies for reporting and recording AERs.

CRN said that in the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA), which was published in the Federal Register on March 23, 2012, and amends the Federal Food, Drug, and Cosmetic Act, FDA estimates that each AER report takes around 3 hours to complete (2 hours to collect information for a report, 1 hour to submit any follow-up reports, 30 minutes to file records). However, says CRN, estimates look closer to two to 10 hours per report, especially when trying to determine whether an AER is serious or non-serious, which may require more investigation.

Moreover, says CRN, many companies invest in systems and the opinions of medical experts for AERs, negating FDA’s contention that there are no capital costs associated with AERs.

Read CRN’s letter here.

Under DSNDCPA, manufacturers, packers, and distributors are required to 1) submit to FDA all serious AERs, 2) submit to FDA any new related medical information that arises a year after an initial AER report is filed, 3) maintain records of both serious and non-serious AERs (records must be kept for a minimum of six years).