Report recommends FDA revises postmarketing processes

By Nick Taylor

- Last updated on GMT

Related tags: Fda

Following a review of the backlog of postmarketing studies the FDA has initiated changes to improve its processes, including developing Manuals of Policies and Procedures (MAPP) to track the status of trials.

By law the US Food and Drug Administration (FDA) must initiate an annual review of postmarketing backlog because in recent years concerns were raised about the number of trials listed as pending.

The review was performed by Booz Allen Hamilton. In total 1531 open postmarketing studies were reviewed, of which 80 per cent are proceeding according to the established timelines, have been submitted for FDA review, have met their goals or are no longer needed.

Having assessed the status of the reviews the report made a number of recommendations. The FDA is evaluating these and has begun initiating changes based on the results of the review.

In addition to developing new MAPP the FDA has established a postmarketing study coordinator and tracking coordinator within each new drug division. Furthermore, the agency has created a postmarketing study database to improve data capture, tracking and generate reports.

Further recommendations

The report makes nine recommendations about how the FDA can improve its postmarketing processes. These include ensuring that post market requirements (PMR) and commitments (PMC) are written to meet specific objectives.

In addition the report calls on the agency to establish specific study start and final report submission milestone dates, to inform sponsors not to wait indefinitely on protocol feedback and capture actual dates of milestone completion.

By implementing these measures, and the others detailed in the report, the authors believe the FDA can reduce the size of the PMR/PMC backlog, help complete them on-schedule and improve tracking.

The complete report can be found here​.

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