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T-33: Compliance with FDA’s Postmarketing Adverse Drug Experience Laws and Regulations

Poster Presenter

Namita Kothary

Consumer Safety Officer
FDA
United States

Objectives

The objective is to communicate frequently cited observations of non-compliance with statutory obligations and regulations based on FDA’s postmarketing adverse drug experience inspections.

Method

We analyzed data from postmarketing adverse drug experience inspections conducted over the past five fiscal years. Data was collected from FDA's electronic inspection tools that are used to generate the FDA Form 483, as well as internal FDA databases used to document inspection outcomes.

Results

The most frequently cited observations of non-compliance related to postmarketing adverse drug experience inspections that occur in the regulated industry include: (1) late or unreported expedited individual case safety reports (15-day alert reports); (2) failure to develop adequate written procedures; and (3) late, unreported, or incomplete aggregate safety reports. Non-compliance associated with these three topics consistently accounted for the majority of all observations cited on Form FDA 483s for fiscal years 2014-2018. Recent Warning Letters for postmarketing adverse drug experience violations cite these three most common violations.

Conclusion

Application holders of drugs and therapeutic biologics as well as manufacturers, packers, and distributors listed on product labels must submit postmarketing safety information to FDA. The FDA conducts postmarketing adverse drug experience inspections of the regulated industry to assess compliance. During an inspection, FDA investigators may observe objectionable conditions. These observations are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements. We reviewed observations cited on Form FDA 483s and identified trends related to late, missing, and incomplete submissions of postmarketing safety information to FDA. These submissions include individual case safety reports, periodic safety reports, and annual reports. FDA relies on complete, accurate, and timely safety information to assist in the ongoing evaluation of a drug’s safety profile and to fulfil the mission to protect and promote public health. Additionally, we noted that a lack of adequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse drug experiences was often linked to instances of non-compliance. Firms are responsible for having adequate measures in place to comply with postmarketing adverse drug experience statutory obligations and regulations. Failure to comply with postmarketing adverse drug experience regulations may result in regulatory actions such as Untitled Letters or Warning Letters. Significant violations may lead to enforcement action if not promptly and adequately corrected.