Congress has long been concerned that firms were not meeting their requirements for timely completion of postmarketing requirements and commitments (PMRS/PMCs) made at time of approval or post-approval in supplemental applications. In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA) and, on September 27, 2007, the President signed the legislation into law. Under Section 921 of the FDAAA, the FDA was required to review all of the backlogged postmarketing requirements and commitments and was also to report to Congress annually on the progress firms were making to complete, finalize, and report on those commitments. The FDA has released its tenth annual report (here). The Agency “identified 1,636 PMRs/PMCs (1,553 in the Center for Drug Evaluation and Research (CDER) and 83 in the Center for Biologics Evaluation and Research (CBER)) that comprise the backlog to which section 921 applies.”
Progress in all areas continues to be made and the FDA reports the lowest number of outstanding and delayed PMRs/PMCs since the initial report.
Table 1 and Figure 1 of the report are reproduced below (sans footnotes; please see the report for further details) and provides tabular and graphic representation of the same numbers for CDER.
Table 2 and Figure 2 of the report reproduced from the report and provide tabular and graphic representations of the same numbers for CBER.
Please refer to the full report cited above for further details.