New FDA Guidance on User Fee Waivers, Reductions, and Refunds

FDA has issued a guidance titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products that outlines FDA’s policies for issuing waivers, refunds, or reductions in prescription drug user fees. The newly issued guidance is a revision of a 1993 guidance titled Draft Interim Guidance Document for Waivers of and Reductions in User Fees.

Under the Prescription Drug User Fee Act (PDUFA), FDA is authorized to assess application fees for certain human drug and biological product applications or supplements. In addition, FDA can assess annual product fees for certain approved drug and biological products, and annual establishment fees for the facilities in which those products are made.

Under PDUFA, FDA will grant a waiver or reduction in fees if an applicant meets the eligibility criteria under one of the following provisions:

• A waiver of reduction is necessary to protect the public health

• The assessment of the fee would present a significant barrier to innovation because of limited resources available to the person or other circumstances

• The applicant is a small business submitting its first human drug application to the secretary for review.

The guidance describes the types of waivers and reductions available under the user-fee provisions of PDUFA and describes FDA’s current thinking on the criteria for meeting eligibility requirements for each type of waiver. A section on exemptions and refunds discusses orphan designated products, applications submitted by state or federal government entities, and instances where an application was withdrawn before any substantial work was performed by the agency. The guidance also describes the procedures for requesting waivers, refunds, or reductions, and discusses the procedure for reconsiderations and appeals of FDA decisions on such requests.