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The FDA Fast Track program: the ins and outs

Prof. G.M. van Dam, MD, PhD

New therapies should get to patients as fast as possible. Especially when it comes to addressing currently unmet medical needs and life-threatening diseases. To encourage the development of these drugs the FDA created special programs to accelerate drug development and review. The FDA Fast Track program is one of the four programs drug developers can apply for to get their drug to patients faster.

What is the FDA Fast Track program?

The goal of the FDA Fast Track program is to make new drugs available to patients earlier. It focusses on drugs for diseases that have currently no curative options or have significant benefits over existing treatments for serious diseases. For example, cancer, diabetes, and heart failure. Of course, deciding whether a disease is serious will always be a matter of judgement. Usually, you look at the survival rate, daily functioning, and potential severe disease progression.

If your drug provides a therapy that currently does not exist, it clearly fulfills an unmet medical need. However, if current treatment is available, you need to show that your new drug is better than the available therapy. There are different ways you can do this.

How to show the benefits of your new drug over available therapy.

First of all, you can use the fact that your drug has a greater effectiveness. For example, it has a better effect on serious outcomes. Your drug is also considered more beneficial if it avoids side effects that current drugs have on patients.

Another way is to show that your drug improves the early diagnose of a disease which in turn leads to an improved outcome. Last, but definitely not least, you can argue that your drug addresses an emerging or expected public health need. A great example of this was the sudden need for COVID-19 vaccines.

How does the FDA Fast Track Program improve your regulatory path?

Besides accelerating the drug development process, Fast Track also gives you an improved regulatory path. When your drug is classified as Fast Track you may receive:

  • More FDA meetings to talk about your drug development plan. This way you ensure that you collect the right data that will help your drug to get approval
  • More written communication with the FDA about topics such as your clinical trial design and use of biomarkers
  • If your drug meets the criteria, you can also apply for FDA’s Accelerated Approval and Priority Review. This would expedite your drug development process even further
  • Ability to do a Rolling Review. This means you can submit completed sections of your Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA instead of waiting until every section of the NDA is completed. Normally, the BLA or NDA review does not start until you submitted the entire application.

How to apply for the FDA Fast Track program.

You can request Fast Track at any time during your drug development process. In your Fast Track application, it is important to clearly argue the seriousness of the disease your drug targets. For example, by explaining the standard-of-care, treatment outcome and (co-) morbidity.

Once you submit your application the FDA will review and attempt to decide withing 60 days. In short, they will decide if your drug fills an unmet need in a serious discussion, as explained earlier.

Besides Fast Track the FDA offers three other expedited programs: breakthrough therapy, accelerated approval, and priority review. All have the intention to give patients earlier access to new and/or therapies. At TRACER, we can help you decide which program best fits your drug to create an optimal drug development and regulatory strategy. Contact us here.


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