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Product Application Review Process - Considerations


Summary of Public Comments

Transparency Report Arrow Considerations

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The Task Force agrees that meetings and informal communications between sponsors and FDA can provide useful information and greater predictability to sponsors and can help avoid unexpected or late-emerging problems in the review of an application.  The cost of drug development may increase when timely answers to industry questions are not provided.  FDA should provide as much information to sponsors as possible.

At the same time, the Task Force believes that a timely review process provides essential benefits to sponsors and patients.  Meetings and frequent informal communications are resource and time-intensive and the FDA staff who prepare for and participate in meetings are oftentimes the same individuals who, among other responsibilities, review product applications.  FDA review staff already spend tens of thousands of hours preparing for and holding meetings with sponsors and a significant number of meetings are held with industry each year.  For example, in FY 2009, in response to 2,162 meeting requests from sponsors, the CDER Office of New Drugs scheduled 1,859 meetings with product application sponsors.

The Task Force therefore considered whether an increase in meetings and other less formal communications would lead to a decrease in review efficiency, i.e., more time would be needed for review, or would lead to a more efficient review process.  The Task Force concluded that given current resources, it is not feasible to significantly increase the number of meetings and informal communications with FDA staff without decreasing review efficiency.  Nevertheless, because of the importance of adequate communication between sponsors and FDA, this issue might be appropriately raised in the context of PDUFA negotiations.

The Task Force also considered the types of issues that may arise during the review of a product application and the methods FDA may use for timely resolution of those concerns.  The Task Force considered whether the need for additional meetings and informal communications could be addressed to some extent, especially for small and first-time applicants, by providing general access to additional, detailed information about the review process.  The Task Force believes that there are efficiencies that may be gained by clearly conveying expectations to sponsors about the process of reviewing applications and about what is needed to request and prepare for meetings.

The Task Force considered the usefulness of providing more information to industry through a tracking system and whether increased disclosure would lead to efficiencies in the review process.  The Task Force also agrees that a workable tracking system could provide greater transparency to sponsors about the review of their applications and cut down on the number of communications with reviewers about the status of a sponsors’ pending application.  At the same time, product applications contain information that should be kept confidential, and the Task Force concluded that there must be a means available to keep that information secure.  To explore the effectiveness and cost of such a system, members of the Task Force and agency employees involved in the product application review process participated in a teleconference with representatives of Health Canada to learn more about the electronic system used by that regulatory agency to track product applications.

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