FDA's experience with pilot projects of its Good Review Management Principles initiative has shown that those efforts to implement best practices across product reviews are very difficult to accomplish within the priority review timeframe.

Speaking at FDC/Windhover's FDA/CMS Summit Dec. 4 in Washington, D.C. Office of New Drug Director John Jenkins said that one of the main lessons learned from the GRMP pilot program is that the principles are very difficult to coordinate within the six-month timeline of a priority review.

Jenkins added that it is "nearly impossible" to manage the GRMP process for a priority application for a drug that needs to be presented to an advisory committee, as preparations for those meetings start about three months before the panel meeting is held.

"That often means that there is very little time between when the application arrives and when we have to start sending briefing packages [to the panel members]. So it's very difficult to meet those timelines," Jenkins said.

Priority review has been viewed by industry as its best chance for approval. As review timelines have slipped, most of the deterioration has been with standard review applications. Priority review designation has remained closely correlated not only with on-time action, but also with a higher chance of first-cycle approval - although recent developments may be putting that in jeopardy (see "Priority Review Slow Down: The Prasugrel Delay," ¹ The RPM Report, October 2008).

Still, industry should be concerned about any change that could potentially undermine the sanctity of the six-month priority review.

The GRMPs - which are intended to streamline and improve the drug review process, and therefore should benefit review timelines - have been in the works for years, but seem to be finally ready (² Also see "FDA’s Good Review Management Practices To Debut In “Near Future”" - Pink Sheet, 16 September, 2008.).

The changes the "21 Century Review Process" will bring

All 17 of CDER's review divisions piloted the process with one application in 2008. FDA has now moved past the pilot stage, gathered the "lessons learned" and modified its program, and is now referring to GRMPs as the "21st Century Review Process."

In describing at the FDA/CMS Summit what the new review practices will mean in practice, Jenkins emphasized that FDA's review activities will shift to earlier in the cycle in order to avoid the "crisis mentality" as the user fee goal date approaches.

For standard review, he said it is the agency's goal to have the primary and secondary level review work completed about two months prior to the PDUFA goal-date to leave time to wrap up labeling discussions and post-marketing study commitments.

FDA's other GRMPs include reviewing the planning and timelines for deliverables, cross-disciplinary teamwork and communication, work distribution throughout the review cycle, involvement of the signatory authority early and often, protection of time for end-of-review activities, and greater transparency to the sponsor during the review.

For industry's part, "the message I'm here to share with all of you ... [is that] you need to learn that you're better off submitting a complete application than submitting an incomplete application and hoping that we'll review your submission during our review clock," Jenkins said.

"We're not going to do that as much in the future as we have in the past. You must do your part if you want GRMP and the 21st Century Review process to be successful."

-Jamie Hammon (j.hammon@elsevier.com)

Good Review Principles Implementation Could Threaten Six-Month Priority Review Timeframe

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