FY 1998 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 by well over 30. And this occurred in a year when the total number of applications (non-fee-paying and fee-paying) dropped for the first time in six years as well.

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.

The tables on the following page summarize the exemption and waiver actions taken by FDA for FY's 1993 through 1996, FY 1997, and FY 1998, and pending waiver requests from the same periods.

EXEMPTIONS AND WAIVERS
(Exemptions counted in Full Application Equivalents)

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