• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

FY 2002 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, PDUFA II new exemptions from 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 (Statutorily repealed by section 5 of Public Law 107-109 effective January 4, 2002).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 for the full application fee for the first application submitted. Before FY 1998, only half of the application fee was waived for small businesses.

The additional statutory exemptions in FY 1998 resulted in a loss of revenue. The increased number of exemptions required by PDUFA II reduced the number of applications that paid 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.

The tables on the following page summarize the exemption and waiver actions taken by FDA for fees payable in FY’s 1998, 1999, 2000, 2001, and 2002, and pending waiver requests for fees payable from the same periods.

EXEMPTIONS AND WAIVERS AS OF SEPTEMBER 30, 2002
Does not Include Data on FY 2003 Waivers Pending or Granted in FY 2003
  FY 1998 FY 1999 FY 2000 FY 2001 FY 2002
           
Exempted Application Fees1          
Orphan Product 16.0 14.5 16.3 14.5 10.0
Pediatric Supplements2 8.0 5.3 12.6 19.0 4.5
Previously Submitted3         7.5
Total Exemptions 24.0 19.8 28.9 33.5 22.0
TOTAL-- Exemptions Granted $6,164,304 $5,377,570 $8,250,743 $10,373,175 $6,893,040
           
Waivers Granted          
APPLICATIONS:
         
Small Business Waivers4 15.0 7.0 8.3 12.0 6.0
Miscellaneous Waivers5 5.0 4.5 8.3 10.3 1.0
Value of Waivers Approved $5,136,920 $3,131,243 $4,492,653 $6,058,275 $1,905,974
PRODUCTS:
         
Waivers Approved 53.0 24.0 19.0 17.9 10.0
Value of Waivers Approved $948,009 $440,736 $379,221 $391,867 $216,300
ESTABLISHMENTS:
         
Waivers Approved 20.0 12.5 11.5 10.4 7.3
Value of Waivers Approved $2,329,436 $1,604,795 $1,636,926 $1,516,242 $1,028,876
TOTAL-- Waivers Granted: $8,414,365 $5,176,774 $6,508,800 $7,966,383 $3,151,150
           
Waivers Pending Decisions          
  FY 1993 Through FY 1998 FY 1999 FY 2000 FY 2001 FY 2002
APPLICATIONS:
         
Waivers Pending       0  
Allowance for Pending Waivers   $0 $0 $0  
PRODUCTS:
         
Waivers Pending 4 6.0 4.0 7.0 12.0
Allowance for Pending Waivers $68,373 $110,184 $79,836 $153,244 $259,560
ESTABLISHMENTS:
         
Waivers Pending 1.5 1.5 2.0 5.3 6.3
Allowance for Pending Waivers $206,283 $192,653 $283,942 $766,4421 $875,681
           
TOTAL -- Waivers Pending $274,656 $302,837 $363,778 $919,686 $1,135,241

 

TOTAL PENDING FOR ALL YEARS: $2,996,198

1Applications counted in full fee equivalents.
2The exemption for pediatric supplements was repealed by P.L. 107-109 effective January 4, 2002.
3Prior to FY 2002 these were included in the total for Miscellaneous waivers.
4Prior to FY 2002 this category was included in counts of applications for which fees were exempted.
5Prior to FY 2002 this category also included counts of applications for which fees were exempted because applications had been submitted previously or which were not inlcuded in the definition of applications that paid 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, PDUFA II new exemptions from 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 for the full application fee for the first application submitted. Before FY 1998, only half of the application fee was waived for small businesses.

The additional statutory exemptions in FY 1998 resulted in a loss of revenue. The increased number of exemptions required by PDUFA II reduced the number of applications that paid 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.

The tables on the following page summarize the exemption and waiver actions taken by FDA for fees payable in FY’s 1998, 1999, 2000, 2001, and 2002, and pending waiver requests for fees payable from the same periods.

EXEMPTIONS AND WAIVERS AS OF SEPTEMBER 30, 2002
Does not Include Data on FY 2003 Waivers Pending or Granted in FY 2003
  FY 1998 FY 1999 FY 2000 FY 2001 FY 2002
           
Exempted Application Fees1          
Orphan Product 16.0 14.5 16.3 14.5 10.0
Pediatric Supplements2 8.0 5.3 12.6 19.0 4.5
Previously Submitted3         7.5
Total Exemptions 24.0 19.8 28.9 33.5 22.0
TOTAL-- Exemptions Granted $6,164,304 $5,377,570 $8,250,743 $10,373,175 $6,893,040
           
Waivers Granted          
APPLICATIONS:
         
Small Business Waivers4 15.0 7.0 8.3 12.0 6.0
Miscellaneous Waivers5 5.0 4.5 8.3 10.3 1.0
Value of Waivers Approved $5,136,920 $3,131,243 $4,492,653 $6,058,275 $1,905,974
PRODUCTS:
         
Waivers Approved 53.0 24.0 19.0 17.9 10.0
Value of Waivers Approved $948,009 $440,736 $379,221 $391,867 $216,300
ESTABLISHMENTS:
         
Waivers Approved 20.0 12.5 11.5 10.4 7.3
Value of Waivers Approved $2,329,436 $1,604,795 $1,636,926 $1,516,242 $1,028,876
TOTAL-- Waivers Granted: $8,414,365 $5,176,774 $6,508,800 $7,966,383 $3,151,150
           
Waivers Pending Decisions          
  FY 1993 Through FY 1998 FY 1999 FY 2000 FY 2001 FY 2002
APPLICATIONS:
         
Waivers Pending       0  
Allowance for Pending Waivers   $0 $0 $0  
PRODUCTS:
         
Waivers Pending 4 6.0 4.0 7.0 12.0
Allowance for Pending Waivers $68,373 $110,184 $79,836 $153,244 $259,560
ESTABLISHMENTS:
         
Waivers Pending 1.5 1.5 2.0 5.3 6.3
Allowance for Pending Waivers $206,283 $192,653 $283,942 $766,4421 $875,681
           
TOTAL -- Waivers Pending $274,656 $302,837 $363,778 $919,686 $1,135,241

 

TOTAL PENDING FOR ALL YEARS: $2,996,198

1Applications counted in full fee equivalents.
2The exemption for pediatric supplements was repealed by P.L. 107-109 effective January 4, 2002.
3Prior to FY 2002 these were included in the total for Miscellaneous waivers.
4Prior to FY 2002 this category was included in counts of applications for which fees were exempted.
5Prior to FY 2002 this category also included counts of applications for which fees were exempted because applications had been submitted previously or which were not inlcuded in the definition of applications that paid fees.

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