Biologics Adverse Experience Reports Take 88 Hours Annually

It takes biologics manufacturers 88 hours on average to file and maintain all the information required for adverse experience reports (AERs), according to the FDA.

Those hours include the time spent filing 15-day postmarketing alerts required by 21 CFR Part 600. The alerts enable the FDA to recommend labeling changes, start removing biological products from the market if needed and assure that manufacturers take appropriate corrective action when necessary. The hours do not include time spent filing MedWatch forms.

The agency calculated the annual burden of recordkeeping based on the annual average of lots released (5,291), number of recalls made (1,841) and number of 15-day and other AERs received (45,707) in fiscal 2006 from 303 firms.

The data are part of an information collection approval request the FDA sent to the Office of Management and Budget for review and clearance. In it, the agency estimates the total annual reporting burden for filing and maintaining AERs will be 636,436 hours.

A copy of the agency’s notice is available at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0073.pdf.