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  1. Postmarketing Requirements and Commitments: Introduction

Postmarketing Requirements and Commitments: Reports

Postmarketing Requirements and Commitments

Postmarket requirement and commitment studies and clinical trials occur after a drug or biological product has been approved by FDA.  Under various statutory and regulatory authorities, FDA can require manufacturers of certain drug products to conduct postmarket studies and clinical trials.  The 2007 Food and Drug Administration Amendments Act (FDAAA) specifically provides FDA with authority to require drug manufacturers to conduct postmarket safety studies and clinical trials to assess possible serious risks associated with the drugs.

For more information, please see Postmarketing Requirements and Commitments: Introduction.

Reports

Annual Report in the Federal Register

The Food and Drug Administration Modernization Act of 1997 requires FDA to publish annually a notice in the Federal Register containing information on the performance of postmarket studies and clinical trials that FDA requires, or has requested, of manufacturers. These are referred to as postmarket requirements (PMRs) and postmarket commitments (PMCs), respectively. This annual report is intended to summarize the data in the FDA internal PMR/PMC databases, which are used to track the status of PMRs and PMCs. 

The annual reports reflect the status of the PMRs and PMCs in relation to their original schedule, or “milestones,” regardless of whether adjustments have subsequently been made to the schedule.1

Note that the numbers published in the annual Federal Register notice cannot be compared directly to the numbers in the backlog review reports or to the numbers resulting from searches of the public database on the PMR and PMC Search website. The annual Federal Register notice lists total numbers for all PMRs and PMCs open during the fiscal year while the backlog review includes only a subset of PMRs and PMCs open as of September 27, 2007. In addition, because FDA’s processes for tracking the status of PMRs and PMCs have evolved over time, there has been variability in the data captured, which has impacted the data reported over time.

The data on the PMR and PMC public website are updated quarterly.

In 2016, FDA issued a combined Federal Register notice for FY 2013 and FY 2014 because starting in 2013 and through 2014, CDER conducted an evaluation of a sample of PMR and PMC data. CDER undertook this evaluation as part of its ongoing quality assurance and process improvements efforts.  The evaluation resulted in updates and revisions to the status of certain PMRs/PMCs.  The 2013-2014 evaluation delayed the issuing of the FY 2013 and FY 2014 Federal Register notices.

As with Federal Register notices for past fiscal years, PMR/PMC data for CDER and CBER are presented together.

In addition, FDA is also providing a supplemental report for fiscal years 2013 and 2014 (see link below).The supplemental report describes the internal evaluation initiated by CDER in 2013, and presents data:

  • For FY2013 and 2014 separately
  • For CBER and CDER separately
  • In  graphical forms that are not feasible for the Federal Register

Annual Federal Register Notices 

Annual Report to Congress on the Backlog of PMRs and PMCs

Section 921 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) added a requirement for FDA to annually “review the entire backlog of postmarketing safety commitments to determine which commitments require revision or should be eliminated, report to the Congress on these determinations, and assign start dates and estimated completion dates for such commitments.” For the purposes of this task, the PMR/PMC backlog was defined as all open PMRs and PMCs (not fulfilled or released) as of the date of FDAAA enactment (September 27, 2007).

Impact of the Backlog Reviews

FDA contracted with Booz Allen Hamilton (BAH) to conduct the first and second annual backlog reviews of CDER PMRs/PMCs. Links to these reports are included below. Initially, 63% of the PMRs/PMCs backlog was categorized as pending, 15% ongoing, 14% submitted, and 7% delayed. After the first annual review (PDF - 422KB), BAH determined the accurate statuses of the PMRs/PMCs in the backlog cohort and established that 14% were pending, 14% ongoing, 36% submitted, 15% delayed, 14% fulfilled, 3% released, and 1% terminated. For 3%, the status was unknown at the time of the external review. The first and second annual PMR/PMC backlog review reports performed by BAH are available here.

FDA has conducted the subsequent backlog reviews. Following the CDER’s first annual review of the PMR/PMC backlog (PDF - 52KB), CDER determined that nearly 80% of CDER’s PMRs and PMCs had been initiated, and more than half had a status of either submitted, fulfilled, or released. Each of the Reports to Congress on the Backlog shows that the PMRs and PMCs in the original backlog are being steadily completed and closed. The number of open PMRs and PMCs in the backlog continues to diminish as applicants complete the required or agreed upon studies and trials, submit final reports, and FDA reviews the final reports and issues fulfillment or release letters as appropriate.

The fifth, sixth and seventh annual backlog reports were all issued in 2015. The fifth annual backlog report (FY 2012) was delayed due to an administrative oversight.

The sixth (FY 2013) and seventh (FY 2014) annual backlog reports were postponed pending completion of an FDA initiated internal audit of the Center for Drug Evaluation and Research (CDER) data on PMRs and PMCs in 2014. This audit was an important component of ongoing quality assurance and improvement efforts, and helped FDA modify policies and procedures to ensure that data on PMRs/PMCs were reliable and complete. FDA determined these activities were critical to ensuring reliability of the reported data on the PMRs and PMCs in the backlog.

FDA’s delay in reporting does not mean there was a delay in the ongoing work to resolve and address the backlog as described in FDAAA.

Other Reports

Final Report on the Independent Evaluation of FDA's Prescription Drug User Fee Act III – Evaluations & Initiatives

As part of ongoing initiatives to improve the process for developing and tracking postmarket requirements and commitments, FDA contracted in 2006 with Booz Allen Hamilton (BAH) to conduct an independent analysis of FDA's postmarket processes and procedures. The final report, describing the results of this analysis and BAH recommendations for improvement, was released in March 2008.   Final Report: Independent Evaluation of FDA's Prescription Drug User Fee Act III – Evaluations & Initiatives (PDF - 369 KB)

Based on the BAH report, FDA developed, revised, and implemented procedures to improve its processes for tracking postmarket requirements and commitments.

The following two Manuals of Policies and Procedures (MaPPs) were published in 2009:

Food and Drug Administration Modernization Act of 1997 (FDAMA)

FDAMA required FDA to prepare a report to Congress by October 1, 2001, that included:

  • A summary of annual status reports submitted
  • An evaluation of sponsor performance in fulfilling agreements with respect to conducting postmarket studies
  • The timeliness of FDA’s review of postmarket studies
  • Any legislative recommendations respecting postmarket studies

That report is available at the following location: Report to Congress: Reports on Postmarketing Studies [FDAMA 130]


FDA will continue to ensure that drug companies report on the status of their postmarket studies and clinical trials and will continue to monitor the progress of these studies on an ongoing basis. 

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1 Note that this may not be true for PMRs required under the Pediatric Research Equity Act (PREA) for which the FDA may have granted a deferral extension as authorized under the Food and Drug Safety and Innovation Act (FDASIA).

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