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U.S. Department of Health and Human Services

For Industry

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Background

Table of Contents

Objectives and Scope of the Study

The Prescription Drug User Fee Act (PDUFA) authorizes the Food and Drug Administration (FDA) to collect user fees for reviewing and processing applications for the approval of certain human drug and biological products. There are generally four types of applications reviewed: New Drug Applications/Biologics License Applications (NDAs/BLAs); Investigational New Drug Applications (INDs); Efficacy Supplements; and Manufacturing Supplements.[1] More information on the Prescription Drug User Fee Act can be found at the following web site: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm

The Prescription Drug User Fee Amendments of 2002 (known as PDUFA III) provided that after user fees were adjusted for inflation; they should be further adjusted to reflect changes in workload associated with review processes of human drug applications. Congressional reports accompanying PDUFA III outlined a methodology for the PDUFA III Workload Adjuster to capture such changes in workload. The Workload Adjuster was utilized to measure changes in workload demand for reviewing drug and biologic applications during Fiscal Year (FY) 2003 through FY 2007. According to FDA and industry[2], and the action taken by Congress in enacting PDUFA IV, the PDUFA III Workload Adjuster was found to be flawed for NDA/BLA and IND applications in two ways:

  • The surrogate for IND workload was the number of new commercial INDs submitted each year. Since each IND application is active for several years, the number of new IND applications submitted in any given year was determined to be a poor surrogate for total IND workload.

The Workload Adjuster did not take into account some significant factors which increased workload required to review an application. During the PDUFA III time period, there was a substantial increase in the numbers of meetings scheduled[3] and Special Protocol Assessments (SPAs) per IND submission. However, the PDUFA III Workload Adjuster only considered changes in the numbers of IND submissions and not the additional review activity required for each application submitted. As part of the scheduled reauthorization of PDUFA III in FY 2007, Congress remedied the deficiencies arising from the implementation of PDUFA III Workload Adjuster in the PDUFA IV Workload Adjuster with adjustments for changes in review activities, which covers FY 2008 through FY 2012, in the following ways:

  • The PDUFA IV Workload Adjuster changed the surrogate for IND workload in the statute from the number of new commercial INDs received each year to the total number of commercial INDs that were active each year. Active IND applications are those that have additional data submitted at least once in the previous 12 months. 
  • Adjustments for changes in review activities will be applied to the number of new NDA/BLA applications and active INDs each FY. The PDUFA IV workload model adjusts these numbers in proportion to the impact of select review activities that fall under each application type. For NDAs/BLAs, adjustments for changes in review activities are based upon the number of NDA/BLA meetings scheduled, labeling supplements and annual reports. For INDs, the adjustments for changes in review activities are based upon the number of IND meetings scheduled and SPAs
  • PDUFA IV specifies that the Secretary shall contract with an independent accounting firm to study the adjustment for changes in review activity applied in setting fees and revenue amounts for FY 2009, and to make changes in the methodology for calculating changes in review activities in future years, if warranted.

Objectives and Scope of the Study

[1] The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Prescription Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. (http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2007_register&docid=fr12oc07-64)

[2] Federal Register Notice / Vol. 72, No. 9 / Tuesday, January 16, 2007/Section II.A.2.b. The FDA published proposed recommendations for the reauthorization of the Prescription Drug User Fee program for the process of human drug application review for FY 2008 to 2012.
(http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2007_register&docid=fr16ja07-60.pdf)

[3] The FDA collects data on the number of meetings scheduled, requested, held, and meeting minutes. Data captured by FDA on meetings scheduled accurately reflect the meetings that actually took place for IND and NDA/BLA reviews, based upon Deloitte’s discussion with key FDA personnel.