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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.
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 (described further below) 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.
Impact of the CDER PMR/PMC Backlog Reviews
The annual Federal Register reports reflect a progressively increasing number of submitted and fulfilled PMRs and PMCs. Following CDER’s first annual review of the PMR/PMC backlog (PDF - 52KB) of the PMR/PMC backlog, CDER determined that nearly 80% of the PMRs and PMCs had been initiated, and more than half had a status of either submitted, fulfilled, or released. Over time, additional PMRs and PMCs have been completed, final reports submitted, and reports reviewed by FDA.
Annual Federal Register Notices
- FY2012 (PDF - 213KB )
- FY2011 (PDF - 112KB )
- FY2010 (PDF - 201KB ) -- Correction Notice (PDF - 181KB )
- FY2009 (PDF - 73KB )
- FY2008 (PDF - 65KB )
- FY2007 (PDF - 57KB )
- FY2006 (PDF - 53KB)
- FY2005 (PDF - 53KB)
- FY2004 (PDF - 59KB)
- FY2003 (PDF - 42KB)
- FY2002 (PDF - 38KB)
Reports to Congress
FDAAA 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. Since FDAAA was enacted, these required postmarket safety studies and trials have generally progressed on schedule.
Annual Backlog Report to Congress
Section 921 of 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).
- Third annual backlog report to Congress: 2012 (PDF - 56KB)
- Second annual backlog report to Congress: 2011 (PDF - 61KB)
- First annual backlog report to Congress: 2010 (PDF - 52KB)
Annual Review of the Backlog
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.
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:
Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments (MAPP 6010.9) was posted on March 9, 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.
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).