FDA - Monitoring Postmarketing Study Commitments
FDA provided us with fulfillment letters for 160 postmarketing commitments that were associated with 68 unique new drug applications. We excluded 15 commitments because they were either not listed in the database or there was a discrepancy between the details in the fulfillment letters and the descriptions in the database that led us to question whether there was actually a match. Of the remaining 145 commitments, we had to exclude 127 for which we could not determine the original scheduled completion dates and/or the dates on which final reports were submitted; this left us with 18 commitments to analyze.
Based on our analysis of the fiscal year 2004 fulfillment letters for postmarketing study commitments, we identified the nine commitments that were fulfilled the latest. We obtained all ASRs and corresponding FDA reviews associated with these commitments from the time the commitments were made through fulfillment, as well as any additional correspondence regarding those commitments. We reviewed this documentation to determine:
Interviews With FDA Officials
(1) why commitments were late and
We also attempted to determine the extent to which FDA reviewers followed up with drug applicants regarding any issues the reviewers may have had with the commitments.
(2) the extent to which FDA reviewers concurred with the progress of commitments as reported by drug applicants.
We interviewed project managers at 14 of the 16 review divisions within FDA. We did not interview officials at the two divisions responsible for overseeing therapeutic biologic drugs because these drugs were outside the scope of our inspection.
Review of FDA Policies, Procedures, and Guidance Documents
We used a structured questionnaire to conduct the interviews. The questionnaire addressed:
(1) FDA’s policies and procedures for monitoring postmarketing study commitments,
(2) the challenges FDA faces in monitoring postmarketing study commitments, and
(3) recommendations for improving the process of monitoring postmarketing study commitments. We conducted all interviews by telephone.
We obtained and reviewed all relevant policies, procedures, and guidance documents for postmarketing study commitments issued by FDA. We used these documents to better understand the process for monitoring postmarketing study commitments.
APPENDIX B DATA TABLES
Appendix Table 1. New Drug Applications With Postmarketing Study Commitments, by Fiscal Year, 1990–2004