Updated FDA Manual Instructs Inspectors to Cite Firms for Not Submitting AERS Reports

April 11, 2007

The FDA added noncompliance with regulations covering submissions of postmarketing adverse event drug reports to the list of reportable Form 483 observations that should be cited during FDA inspections, according to the 2007 Investigations Operations Manual (IOM).

The previous IOM listed 17 reportable observations and the only one pertaining to postmarketing adverse event reporting applied to medical devices.

The agency also altered its instructions relating to investigator use of affidavits, directing FDA personnel to note on the document whether the employee refuses to sign the affidavit and include the circumstances of the situation and the reason for the employee's refusal.

Instructions to inspectors on accessing company electronic databases during inspections were also updated to notify FDA personnel that they should not directly access the information.

Do not personally access a firm's electronic records, databases or source/raw data during the course of an inspection," the FDA wrote. However, the agency does provide procedures for inspectors to obtain necessary electronic information.

FDA staffers are instructed to "oversee" company personnel accessing the systems and have them answer inspectors' questions, the FDA said. Inspectors are also supposed to request electronic queries pertaining to information of interest and have firms generate reports both in hard-copy format and on an electronic storage device.

The report can be accessed at www.fda.gov/ora/inspect_ref/iom/ ( http://www.fda.gov/ora/inspect_ref/iom/ ).