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Regulatory Focus™ > News Articles > 2020 > 4 > PDUFA, BsUFA resource capacity planning: Report recommends refinements

PDUFA, BsUFA resource capacity planning: Report recommends refinements

Posted 03 April 2020 | By Michael Mezher 

PDUFA, BsUFA resource capacity planning: Report recommends refinements

A new report from Booz Allen Hamilton commissioned by the US Food and Drug Administration (FDA) recommends refinements to the agency’s workload capacity planning adjustment methodology for its prescription drug (PDUFA VI) and biosimilar (BsUFA II) user fee programs.
 
Background
 
A workload adjustment mechanism was first introduced under PDUFA III, as “a means to adjust the annual PDUFA target revenue to account for long-term changes in the volume of certain regulatory submission.”
 
However, FDA says its workload adjustment methodology has been a source of debate during each subsequent reauthorization process and has seen major revisions in different iterations of the user fee programs.
 
FDA also notes that its workload adjustment methodology has been the subject of numerous studies that have indicated that the adjustment methodology, while suboptimal, is the “best method reasonably possible based on the data available to FDA at that time.”
 
Under PDUFA VI, FDA committed to hiring an independent firm to evaluate its methodology and provide recommendations to improve its accuracy and to establish a resource capacity planning capability. For the time being, the agency is using an interim methodology to calculate the adjustments.
 
For BsUFA, FDA says it will review its options based on the study for PDUFA to develop its first capacity planning adjustment, something the biosimilar program lacked in its first iteration.
 
Report and Recommendations
 
The 25-page report makes five main recommendations for FDA to improve its capacity planning adjustment methodology but finds that overall FDA’s methodology and current implementation of its resource capacity planning “align conceptually” with the agency’s objectives.
 
Among the recommendations are suggestions for FDA to weigh whether adding prediction intervals to its forecasts would “add practice value” and to consider increasing the interpretability of its models.
 
Another recommendation is for FDA to review how other related areas of its work, such as postmarket safety review and guidance development, could be factored into the methodology.
 
The report also calls on FDA to continue to make refinements to its managerial adjustment process by reviewing the accuracy of past years’ adjustments, developing business scenarios for future years and creating metrics to show how long it takes the agency to hire new employees for different positions and disciplines.
 
Lastly, the report suggests that FDA include the “overall methodology assumptions, rationale, and procedures in related documentation to help provide a baseline as the methodology evolves over time.”
 
FDA is now soliciting public comments on the report and says it will develop a “new robust methodology” to use going forward based on the recommendations and the comments it receives.
 
Federal Register Notice, Report

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