What is the Fast-Track Designation?

The Fast-Track Designation is a critical regulatory mechanism employed by the United States Food and Drug Administration (FDA) aimed at expediting the review and development process for drugs and biologics intended to treat serious conditions and fill unmet medical needs. Established under the FDA Modernization Act of 1997, this designation acknowledges the pressing necessity for new therapies in areas where patients lack sufficient treatment options. The purpose of Fast-Track Designation is to facilitate rapid access to new drugs.

What is the advantage of a Fast-Track Designation?

The advantage of the Fast-Track Designation is that it has the potential to significantly reduce the time it takes for innovative treatments to reach patients who are in urgent need. By facilitating a closer and more frequent interaction between drug developers and the FDA, the designation aims to address critical health issues more efficiently, ensuring that promising therapies can navigate the regulatory process at an accelerated pace. This is especially crucial for conditions that are severe, life-threatening, or have a substantial impact on day-to-day living, where the availability of effective treatments can dramatically enhance patient outcomes and quality of life

The Fast-Track Designation aims to tackle an array of serious conditions. Furthermore, it is important to provide patients with treatment options particularly when the suggested therapy may offer more benefits than the currently available therapy. However, a fast track designation therapy must be able to demonstrate this advantage, over the current available therapy. According to the FDA, these include:

• “Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes”
• “Avoiding serious side effects of unavailable therapy”
• “Improving the diagnosis of serious conditions where early diagnosis results in an improved outcome”
• “Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment”
• “Ability to address emerging or anticipated public health need”

What does it mean if a drug is given a Fast-Track Designation?

Medicines that are given the Fast Track Designation by the US FDA allow the manufacturer to participate in more meetings with the US FDA in order to have discussions surrounding the product development plan and ensure appropriate data can be collected in order to support product approval. These stakeholders may also communicate more with he US FDA, through written communication, about the design of the clinical trial and use of biomarkers. Medicines under the Fast Track Designation can also be eligible for the FDA’s Accelerated Approval and Priority Review pathways, provided the relevant criteria is met. These medicines can also be eligible for “Rolling Review” which means that the drug company can submit completed sections of the BLA or NDA for FDA review instead of waiting for each NDA section to be completed before having the entire NDA reviewed. Companies must request the Fast Track Designation- it can be initiated at any time during drug development process. The US FDA has 60 days after the request to device whether the proposed product fills unmet needs for a serious condition.