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On the Fast Track: Fast Track Designation for Your 505(b)(2) Drug Development Program

One of the tenets of the FDA is to get safe and effective drugs to market as soon as possible. To expedite approval of products for which there is the greatest clinical need, the FDA offers four expedited programs to get beneficial therapies to patients faster: priority review, accelerated approval, breakthrough therapy designation, and fast track designation. In this blog post, we will focus on fast track designation and how 505(b)(2) products can qualify for this program.

Fast track designation history

The roots of expedited programs like fast track designation date to the AIDS crisis of the 1980s, when there were no established or FDA-approved treatments for HIV/AIDS. Under the development framework at the time, there were incredibly long timelines for drug approval. Therapies under development for HIV/AIDS, like zidovudine (better known as AZT), could not meet the risk-benefit requirements. Patients and caregivers were outraged and began to seek out any treatment that had anecdotal evidence of efficacy, regardless of risk.

This period led to many important changes at the agency, most notably the Prescription Drug User Fee Amendments, and the recognition of a different risk-benefit threshold for patients with life-threatening and debilitating diseases. The prioritization of applications was amended to reflect this view. The first expedited programs, priority review and accelerated approval, were created in 1992 to shorten the timelines for demonstration of therapeutic efficacy (through use of surrogate markers) and reduce the timeframe of NDA review by the FDA.

While priority review and accelerated approval benefit late-stage development, fast track designation (introduced in the Food and Drug Modernization Act of 1997) offers an expedited program for products at an earlier stage of development.

Fast track designation criteria

As described in Section 506(b) of the FD&C Act, a product can be designated as a fast track product “if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.”

At Premier Consulting, we’re often asked if 505(b)(2) programs can qualify for fast track designation, and the answer is yes. Any product, independent of its 505(b)(1) or 505(b)(2) classification, is eligible for this program. As described below, as long as the product is being made for a serious condition and has the potential to address an unmet medical need, it can be granted fast track designation.

The qualifying criteria for fast track designation are as follows:

Serious condition. The FDA considers a condition “serious” if it has a substantial impact on day-to-day functioning or survival, or if the condition, left untreated, will progress in severity. The drug under development must have an effect on the condition itself or on a serious aspect of the condition. This can include any of the following:

  • A product that has a direct effect on the serious condition
  • A diagnostic product intended to improve diagnosis or detection of a serious condition in a way that would lead to improved outcomes
  • A product intended to mitigate or prevent a serious treatment-related side effect
  • A product intended to avoid or diminish a serious adverse event associated with available therapy for a serious condition
  • A product intended to prevent a serious condition or reduce the likelihood that it will progress to a more serious condition or a more advanced stage of disease

Address an unmet medical need. The FDA considers an unmet medical need one “whose treatment or diagnosis is not addressed adequately by available therapy.” The agency makes the following considerations when determining if a drug will address an unmet medical need:

  1. Currently no available therapy: If there is no available therapy, clearly there is an unmet need.
  2. Therapy for the serious condition exists: If there is a current treatment for the serious condition, fast track designation is still possible. A new treatment would address an unmet medical need if the treatment:
    • Has an effect on a serious outcome of the condition that is not known to be influenced by available therapy
    • Has an improved effect on a serious outcome of the condition compared with available therapy
    • Has an effect on a serious outcome of the condition in patients who are unable to tolerate or failed to respond to available therapy
    • Can be used effectively with other critical agents that cannot be combined with available therapy
    • Provides efficacy comparable to the available therapy while avoiding serious toxicity that occurs with available therapy, avoiding serious toxicity that is common and causes discontinuation of treatment of a serious condition, or reducing the potential for harmful drug interactions
    • Provides safety and efficacy comparable to available therapy but has a documented benefit (such as improved compliance) that is expected to lead to an improvement in the serious condition
    • Addresses an emerging or anticipated public health need (such as a drug shortage)
  3. Therapy for the serious condition was approved based on a surrogate endpoint: For treatments approved under accelerated approval (meaning a surrogate endpoint was used as the basis of efficacy), if clinical benefit has not yet been confirmed in post-approval studies, new products for the same serious condition will be considered for fast track designation.

The amount of information needed to demonstrate that the product addresses an unmet medical need will depend on the product stage of development. Notably, if the product is early in development, data from nonclinical models, pharmacologic data, or a mechanistic rationale can be used. If the product is in more advanced stages of development, clinical data may be needed to demonstrate the potential to address an unmet medical need.

Fast track designation application timeline

Fast track designation can be requested as early as the IND. It also can be requested at any time thereafter, although ideally no later than the pre-NDA (or pre-BLA) meeting.

Fast track designation response time

The FDA response time for fast track designation is within 60 calendar days of receipt of the request.

Fast track designation benefits

Fast track designation confers important regulatory benefits. First, the development program can be accelerated through increased interactions with the FDA. In addition to pre-IND, EOP1, or EOP2 meetings to discuss key developmental issues, additional meetings with the FDA are possible and can be scheduled as appropriate. Additionally, the product could be eligible for priority review at NDA/BLA submission if supported by the appropriate clinical data. Further, if the sponsor submits preliminary evidence of clinical efficacy, the agency may consider reviewing portions of the marketing application before the application is complete (known as “rolling review”).

In addition to the regulatory perks, fast track designation carries value for your business. A recent analysis found that the development time from IND application to FDA approval was, on average, a year shorter for fast track designation products than for products without this designation (Hwang, 2017).

Think your product may qualify for fast track designation? Premier Consulting has used innovative approaches to help sponsors qualify for these programs and use the regulatory benefits to their full potential. We have experience with the FDA’s expedited programs and can provide guidance and expertise to determine if your program meets the requirements for fast track designation. For more information, contact us.