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Appendix B: Exemptions and Waivers

Back to Table of Contents: PDUFA 2009 Financial Report

Beginning in FY 1993, PDUFA directed FDA to waive or reduce fees in five different circumstances:

  • when a waiver is necessary to protect the public health;
  • when a fee is a significant barrier to innovation;
  • when the fees paid exceed FDA's costs of reviewing a firm’s human drug applications;
  • when imposition of the fee creates an inequity between certain 505(b)(1) and 505(b)(2) human drug applications (this waiver provision was deleted in PDUFA III); and
  • when a sponsor withdraws a pending human drug application after FDA has filed it, but before FDA has performed substantial work on the marketing application.

In addition, under PDUFA II, new exemptions from application fees were added beginning in FY 1998.  These specific exemptions are automatic and do not require a waiver request.  They include:

  • human drug applications for designated orphan products (designated for rare diseases or conditions affecting fewer than 200,000 patients in the United States);
  • supplemental applications for pediatric indications for use (statutorily repealed by section 5 of Public Law 107-109, effective January 4, 2002.)

Beginning in FY 1998, PDUFA II also provided a waiver, for certain small businesses, of the full application fee for the first application submitted.  Before FY 1998, only half of the application fee was waived for small businesses.

The increased number of exemptions required by PDUFA II reduced the number of applications that require the payment of fees.  Fees may be waived or reduced under the waiver provisions of the statute.  Many of the application fee waiver requests FDA received through FY 1997 pertained to orphan products; since designated orphan products are now given automatic exemptions, the number of waiver requests for application fees has decreased substantially.

Additionally, beginning in FY 2008, PDUFA IV also provided exemptions for product fees and establishment fees for certain approved orphan products (See 21 USC 379h (k)).

The tables on the following page summarize the exemption and waiver actions taken by FDA for fees payable in the five most recent fiscal years.

EXEMPTIONS AND WAIVERS AS OF SEPTEMBER 30, 2009
Does not Include Data on FY 2010 Waivers Granted in FY 2009

Exempted Application Fees 1

ExemptionsFY 2005FY 2006FY 2007FY 2008FY 2009
      Orphan Product28.523.821.327.823.8
      Previously Submitted3.56.04.54.07.5
Total Exemptions32.029.825.831.831.3
TOTAL Value of Exemptions$21,504,000$22,830,150$23,077,150$37,401,500$38,975,000

   1  Actual number of Exempted Applications received in full fee equivalents.

Exempted Orphan Product and Establishment Fees (new in FY 2008)

ExemptionsFY 2005FY 2006FY 2007FY 2008FY 2009
      Orphan Product Fee Exemptions - - -1416
      Value of Product Fee Exemptions - - -$910,420$1,144,320
      Orphan Establishment Fee Exemptions - - -5.247.45
     Value of Establishment Fee Exemptions - - -$2,056,963$3,169,869
Total Value of Product and Establishment Fee Exemptions - - -$2,967,383$4,314,189

Waived Fees

WaiversFY 2005FY 2006FY 2007FY 2008FY 2009
APPLICATIONS 2
Small Business Waivers 12.011.014.025.016.0
Miscellaneous Waivers (Includes PEPFAR)12.013.014.021.010.0
Value of Waivers Approved$16,128,000$18,417,600$25,093,600$54,188,000$32,427,200
PRODUCTS
Waivers Approved32.022.023.814.09.0
Value of Waivers Approved$1,334,720$926,860$1,184,344$910,420$643,680
ESTABLISHMENTS
Waivers Approved17.012.212.16.53.0
Value of Waivers Approved$4,453,991$3,223,704$3,782,272$2,552,550$1,276,800
TOTAL Value of Waivers Granted$21,916,711$22,568,164$30,060,216$57,650,970$34,347,680

2  Actual Number of Application Fee Waivers Granted--number of waived applications actually received may vary slightly

TOTALSFY 2005FY 2006FY 2007FY 2008FY 2009
GRAND TOTAL--Exemptions & Waivers$43,420,711$45,398,314$53,137,366$98,019,853$77,636,869

Source: Periodic waiver reports and application counts compiled by the CDER Associate Director for Policy and Fee-Exceed-Cost Waivers Reported by the Office of Financial Management.

Next Section:  Appendix C - Allowable and Excluded Costs for the Process for the Review of Human Drug Applications