PDUFA VI: FDA Wary Of Industry Proposals With More Metrics
This article was originally published in The Pink Sheet Daily
Executive Summary
Review system proposals could overburden staff, FDA says; formal meeting goals already on tap for changes.
A ballooning number of formal meetings and other goals is causing FDA to push back against some proposed PDUFA VI enhancements.
It appears industry wants to increase the metrics on FDA for the new drug review program. But the agency is growing concerned about the burden they could add to staff and is afraid to commit to any “additional metric goals.”
Agency officials also told industry representatives that they were “reviewing the status of current resources for the review program to help to reduce the stress and strain on reviewers.”
More details of its plan and details about the “resources required to meet timeframes for all other current internal goals” were expected at future meetings, according to minutes of an Oct. 20 PDUFA VI Steering Committee meeting.
The agency told industry it cannot become consumed with formal goals.
“As a public health agency, it is important to maintain some flexibility within its operating environment to ensure that the agency can manage numerous priorities required in fulfilling its public mission,” the agency said in the minutes.
Resources already have emerged as an issue in the PDUFA reauthorization negotiations.
The agency has talked about potentially changing the establishment fee to improve PDUFA revenue predictability and simplify the fee structure (Also see "PDUFA VI Might Adjust Establishment Fees; FDA Aims For Simplification" - Pink Sheet, 9 Nov, 2015.).
FDA also has hinted that PDUFA may be growing too large and its responsibilities too burdensome.
Acting Commissioner Stephen Ostroff has said PDUFA should be reviewed to determine whether any programs should be scaled back or modified in order to focus on those items that produce the most value (Also see "Does PDUFA Need A Haircut? FDA Ponders Trimming Its Responsibilities" - Pink Sheet, 15 Jul, 2015.).
A number of ideas also have been floated to change the review system, including some to relieve workload burdens.
Agency officials may be looking to tweak the “Program,” its review system created in PDUFA V that allows mid-cycle communications and late-cycle meetings between FDA and sponsors in return for a longer review time (Also see "PDUFA Negotiations Begin With FDA Seeking Review System Reform" - Pink Sheet, 13 Oct, 2015.).
Stakeholders have suggested potentially creating a user fee for the breakthrough therapy program as a way of eliminating frivolous requests, but Office of New Drugs Director John Jenkins is concerned about perceptions that could be created by charging a fee for a specific piece of work (Also see "Breakthrough Requests: FDA Adds Quick Screen To Pare Workload" - Pink Sheet, 13 Nov, 2015.).
FDA’s Scheduling Nightmares
FDA already has suggested that timeframes for formal meeting scheduling be extended in PDUFA VI in order to allow more flexibility.
Agency officials said there now are about 10 formal meetings per day that are led by OND, according to the Oct. 20 meeting minutes.
FDA said it is becoming increasingly difficult to find time for senior officials to attend the meetings.
“One of the biggest rate-limiting steps in achieving the target timeframes for the increasing numbers of meetings is the difficulty finding time in senior-level staff schedules to ensure their participation,” the agency said in the minutes.
Along with the growing volume, FDA said “the complexity of scientific and regulatory issues addressed by formal meetings have increased since procedural goals were first established,” according to minutes of an Oct. 13 PDUFA VI Steering Committee meeting. That likely means more preparation time is required than previously.
Industry agreed to consider the proposal, but may not be interested in potentially giving FDA much more leeway to schedule or conduct the meetings, since it could slow drug development programs.
FDA Formal Meeting Performance Has Slipped
Formal meetings are required by the PDUFA agreement to be scheduled and conducted within a certain number of days.
FDA’s fiscal year 2014 PDUFA performance report revealed its problems reaching meeting management goals. It exceeded its performance goals in only two of nine categories that year, according to preliminary figures. The previous fiscal year it met or exceeded goals in four of the nine categories.
The report also indicated that meeting requests were increasing. Type C meeting requests increased 25% in FY 2014 compared to the previous five years (Also see "PDUFA VI: Biosimilar Meetings Could Be Model For Earlier User Fee Payments" - Pink Sheet, 17 Jul, 2015.).
In addition, FDA staff identified problems with meetings under the new review system. Among the suggested changes was the ability to opt out of a late-cycle meeting if no significant issues remain.
Sponsors said that late-cycle meetings were valuable, however (Also see "PDUFA V Reviews Are ‘Best Ever’ For Some Sponsors, Maybe Not FDA" - Pink Sheet, 6 Apr, 2015.).