FDA issued a draft guidance for industry on Mar. 11, 2011, titled User-Fee Waivers, Reductions, and Refunds for Drug and Biological Products, that offers recommendations to applicants seeking such actions under the Federal Food, Drug, & Cosmetic Act (FD&C Act). A similar draft guidance was issued in July 1993. The new document clarifies the types of waivers, refunds, and reductions available under the user-fee provisions of the FD&C Act as well as the procedures for handling these requests, including how to appeal an FDA decision.

The guidance is tied to the Prescription Drug User-Fee Act (current version IV), which allows FDA to assess and collect user fees from applicants for certain human drug and biological products. In addition, FDA can assess annual product fees for certain approved drug and biological products, as well as annual establishment fees for the facilities in which those products are made in final dosage form, states the draft guidance. However, the amount FDA collects in total from these fees is “independent of the number of waivers or reductions in fees that are granted… Therefore, the more waivers or reductions are granted, the more fees must be increased the following year for applications, products, and establishments subject to fees to meet the annual statutory revenue targets.”

The new draft guidance explains how an applicant may qualify for a waiver or reduction in user fees. Three potential qualifications for applicants are available to protect the public health; to avoid a barrier to innovation (i.e., the assessment of the fee would present a significant barrier in developing the product because of limited resources); or to maintain a small business (i.e., the applicant is a small business submitting its first drug application for review). The guidance goes into detail about each potential qualification for a waiver or reduced fee, and provides examples of how a company might meet the requirements.

For example, if a company is requesting a waiver because its drug product protects the public health, the company might explain to FDA how the drug product offers a significant improvement compared with other marketed products, including other dosage forms or routes of administration and nondrug products or therapies; whether the drug is designated as a priority drug (e.g., fast-track status, new molecular entity); and whether the drug product demonstrates an increased effectiveness in the treatment, prevention, or diagnosis of disease. Additional considerations for applicants provided in the draft guidance document regarding barriers to innovation and costs for small businesses are provided in the draft guidance document.

The draft guidance also provides clarification of timing for when to request a waiver or reduced fee (i.e., no later than 180 calendar days after the fee is due). The consequences of not paying the application fee, and when to submit a request for a waiver or reduced fee to avoid paying the application fee (about three to four months before submitting an application) also are addressed. Finally, the document provides information about the content and format of such requests, and about how to handle refund requests as well as appeals or requests for reconsiderations should FDA deny an application.

Industry and public comments on the draft guidance are due within 90 days of the document’s publication date.