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FY 2000 PDUFA Financial Report: Appendix B

Table of Contents

Previous Section: Appendix A: Conditions for Assessment and Use of Fees

 

EXEMPTIONS AND WAIVERS

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 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 FDAMA new exemptions from fees have been 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.

Beginning in FY 1998, FDAMA also provides a waiver for certain small businesses for the full application fee for the first application submitted. Before FY 1998, only half of the application fee could be granted a small business exception.

The additional statutory exemptions in FY 1998 resulted in a substantial loss of revenue, as can be seen at the top of the chart on the next page. The increased number of exemptions required by FDAMA amendments reduced the number of applications that paid fees.

All fees may be waived or reduced under the waiver provisions of the statute. Many of the application fee waiver requests FDA received in the past pertained to orphan products; since designated orphan products are now given automatic exemptions, the number of waiver requests for application fees has decreased substantially.

During the past year, all but one of the pre-1998 requests for waivers were resolved. The tables on the following page summarize the exemption and waiver actions taken by FDA for fees payable in FY's 1993 through 1997, 1998, 1999 and 2000, and pending waiver requests for fees payable from the same periods.

EXEMPTIONS AND WAIVERS AS OF SEPTEMBER 30, 2000
 
  FY 1993 Through FY 1997 FY 1998 FY 1999 FY 2000
         
Exempted Application Fees        
Orphan Product Treated as Waivers 16.0 15.0 14.0
Pediatric Supplements Treated as Waivers 8.0 5.3 12.5
Small Business 18 15.0 7.0 8.0
Total Exemptions 18 39.0 27.3 34.5
TOTAL VALUE of Exemptions Granted $3,272,000 $10,016,994 $7,419,685 $9,858,030
         
         
Waivers Granted        
APPLICATIONS:
       
Waivers Approved 75.1 5.0 11.5 8.4
Value of Waivers Approved $11,267,750 $1,104,269 $3,131,243 $2,400,216
         
PRODUCTS:
       
Waivers Approved 261.0 52.0 23.0 17.0
Value of Waivers Approved $3,003,600 $929,418 $422,372 $339,303
         
ESTABLISHMENTS:
       
Waivers Approved 65.0 20.0 12.5 8.3
Value of Waivers Approved $7,471,500 $2,329,436 $1,604,795 $1,182,618
         
TOTAL VALUE of Waivers Granted: $21,742,850 $4,363,123 $5,158,410 $3,922,137
         
         
Waivers Pending Decisions        
APPLICATIONS:
       
Waivers Pending 0 0 0 1.5
Allowance for Pending Waivers $0 $0 $0 $428,610
         
PRODUCTS:
       
Waivers Pending 0 2.0 4.0 10.0
Allowance for Pending Waivers $0 $36,918 $73,456 $199,590
         
ESTABLISHMENTS:
       
Waivers Pending 0 1.0 3.0 9.0
Allowance for Pending Waivers $0 $128,435 $385,305 $1,274,900
         
OTHERS $572,400 $0 $187,347 $588,412
TOTAL POTENTIAL COST of Waivers Pending: $572,400 $165,353 $646,108 $2,491,512

 

TOTAL PENDING FOR ALL YEARS: $3,875,373

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