On Wednesday, June 20th, FDA announced the availability of a draft guidance entitled "Prescription Drug User Fee Waivers, Reductions, and Refunds for Drug and Biological Products." The guidance is an updated version of the original final guidance, which was published in September 2011.
Types of Waivers, Refunds, and Reductions
Under section 736(d) of the Food, Drug, and Cosmetic (FD&C) Act, there are three main instances where the FDA will grant applicants a waiver or reduction in user fees. These include situations where:
- A waiver or reduction is necessary to protect public health
- Does the product protect public health?
- Is the waiver necessary to continue an activity that protects 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
- Is the product or other products or technologies under development by the applicant innovative?
- Would the fee(s) be a significant barrier to the applicant’s ability to develop, manufacture, or market innovative products or to pursue innovative technology?
- The applicant is a small business submitting its first human drug application to FDA
- To qualify for a small business waiver, an applicant must:
- Employ less than 500 employees, including employees of affiliates
- Have no drugs already approved under a human drug application and delivered into interstate commerce
- Be submitting first human drug application, including affiliates
Procedures for Requesting Waivers, Refunds, or Reductions
According to section 736(i) of the FD&C Act, “to qualify for a waiver or reduction in user fees as well as a refund for a fee paid, an applicant must submit to FDA a written request for a user fee waiver, reduction or refund no later than 180 calendar days after the fee is due.” It is important to note that human drug applications without user fees are considered incomplete, and will not be accepted by FDA for filing, even if a sponsor’s failure to pay is due to waiver or reduction delays. As such, FDA suggests that applicants should submit requests for waivers or reductions three to four months before the submission of the application.
Reconsideration and Appeals Process
If FDA denies or partially denies a request, it is possible to submit a reconsideration request. Reconsideration requests must be made within 30 calendar days of the original FDA decision. Applicants should include any relevant updated financial information when submitting the request.
Upon reconsideration, a request may be granted or denied. If the request is denied, the applicant can appeal the denial. Appeal requests should be made within 30 calendar days of the decision to uphold the denial. Included in the appeal should be:
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- The original waiver request
- The denial of the original waiver request
- The reconsideration request
- The denial of the reconsideration request
- A statement of the applicant’s belief that the prior conclusions were in error
However, it is important to note that no new information should be included in the appeal request.
Public comment for this updated draft guidance will be open for 60 days following the publication of the Federal Register notice.
Are you in the process of preparing a human drug application for submission to the FDA? You could be eligible for a user fee waiver or reduction. We can help prepare and submit your application and determine whether you are a candidate for a waiver or reduction. To learn more about our services and how we can help you, contact us today.
