FCR - First Clinical Research Laws, Regulations & Guidelines

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FDA - Monitoring Postmarketing Study Commitments

FDA concurred with two of our three recommendations. Specifically, FDA agreed with our recommendations to improve the management information system for monitoring postmarketing study commitments and to ensure that postmarketing study commitments are being monitored and ASRs are validated. The agency highlighted ongoing efforts to enhance its postmarketing study commitment database and reporting capabilities, train its review division staff on ASR validation procedures, and standardize the process by which postmarketing study commitments are requested and reviewed.

FDA disagreed with our recommendation that it instruct drug applicants to provide additional, meaningful information in their ASRs, citing that implementing such a recommendation would require new regulations.

OFFICE OF INSPECTOR GENERAL RESPONSE

In disagreeing with our finding, FDA highlighted several areas in which it has made improvements. We appreciate that FDA has taken steps to improve its monitoring of postmarketing study commitments. However, our review of the postmarketing study commitment database and annual status reports, as well as our interviews with agency officials, demonstrated that FDA cannot readily identify whether or how timely postmarketing study commitments are progressing toward completion for the period of our review.

We recognize that our recommendation that FDA instruct drug applicants to provide additional, meaningful information in their ASRs could require regulatory changes. In response, we added language to our recommendation acknowledging that FDA may need to seek regulatory changes to improve its system for monitoring postmarketing study commitments.

We also made other minor changes to our report based on FDA’s technical comments.

TABLE OF CONTENTS

EXECUTIVE SUMMARY
INTRODUCTION
EXTENT OF COMMITMENTS
FINDING
   FDA cannot readily identify progress
      Missing or incomplete information
      Limited utility of information
      Ineffective management information system
      Monitoring is not a top priority
RECOMMENDATIONS
   Agency comments
   Office of Inspector General response
ENDNOTES
APPENDIXES
   A: Methodology
   B: Data Tables
   C: Agency Comments
ACKNOWLEDGMENTS

INTRODUCTION

OBJECTIVES

1. To determine the extent to which new drug applications involve postmarketing study commitments with the Food and Drug Administration (FDA).

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