Requesting Fast Track designation: What you need to know

Time is of the essence for patients who have serious and life-threatening conditions – especially when they have few therapeutic options. The health of these patients may not outlast the traditional drug development process.

That’s why Congress created the Fast Track designation program in 1997, with the passage of the FDA Modernization Act (FDAMA). Fast Track designation is one of four programs that can help expedite the development and review of drugs intended to address unmet medical need in the treatment of serious conditions.

Over the years, the programs has become widely used by sponsors developing therapies for serious conditions. According to industry records, the FDA received 27 requests and granted 21 in the program’s first year. In 2016, 187 requests were received and 131 were granted.

If you’re interested in pursuing a Fast Track designation for your therapy, here are some of the basics you’ll need to know.

When can Fast Track designation be requested?

Fast Track designation should be considered when there is no adequate therapy for a serious condition; and when the potential to address an unmet medical need can be demonstrated by evidence of nonclinical activity, mechanistic rationale, theoretical rationale, pharmacologic or clinical data, depending on the stage of development. A drug designated as a qualified infectious disease product is also eligible for designation.

What are the key benefits of Fast Track designation?

• The sponsor has opportunities for frequent meetings and communications with the FDA, including pre-IND, end-of-phase 1, end-of-phase 2, pre-NDA, or pre-BLA meetings – as well as consultation meetings to discuss clinical study designs, application-enabling data, marketing application structure and content.
• The product could be eligible for Breakthrough Therapy designation, accelerated approval and priority review if relevant criteria are met.
• The product could be eligible for a rolling review of portions of the marketing application before the entire application has been submitted. This is granted if FDA determines that the product may be effective based on a preliminary evaluation of the clinical data.

At what point in the drug development process can a sponsor request Fast Track designation?

Fast Track designation is usually sought early in the drug development process. Although it can be requested when an IND is first submitted, or at any time thereafter, it should ideally be requested prior to the premarketing application meeting, in order to receive the full benefit of the program.

How does a sponsor request Fast Track designation?

A sponsor can request designation when an Investigational New Drug (IND) application is initially submitted, or anytime thereafter, as an amendment to the IND. The FDA will review the request and make a decision within 60 days, based on whether the drug has the potential to address an unmet medical need for the treatment of a serious condition.

The FDA’s Fast Track designation program has the potential to significantly expedite a product’s development and approval. However, sponsors who want to get their product to patients as quickly as possible need to ensure they understand the best practices most likely to lead to a successful request for Fast Track designation. Many sponsors see value in partnering with a regulatory affairs expert – who has proven experience working with the FDA – to help them avoid common pitfalls and guide the designation request process.