Founded in 1906, the Food and Drug Administration (FDA) is the oldest comprehensive “end-to-end” consumer protection agency of the United States federal government. For over 110 years, the FDA’s standard scrutinization protocol for new drugs that treat major illnesses was to subject them to a long series of tests and third party assessment before regulators issued approval for market release. Since its inception, the FDA has been known for taking months or years to review new drugs for approval. Only in select instances would FDA officials approve a new drug for expedited “Fast Track” review. 

Early 2018, the FDA made a key change to it’s regulatory review process by ramping up its Fast Track program. FDA regulators are reviewing, approving and allowing release of new medicines to market at the fastest pace in history. 

This new approach is generating criticism from some medical professionals who are having to catch up with details of new therapies that treat common major illnesses. A statement issued by the FDA aims to note the obvious counter, that “speeding the availability of drugs that treat serious diseases are in everyone’s interest, especially when the drugs are the first available treatment or if the drug has advantages over existing treatments.”  

The FDA’s old stigma of “boring and slow” has been traded for new criticisms – likely due to the term ‘Fast Track’ which some interpret to imply “speedy, perhaps reckless regulator approval without full drug review”. This new stigma percolating across the healthcare community is fueled by a common mis-conception about the Fast Track program, namely that the FDA developed four distinct solutions to make safe drugs available as fast as possible, also including Breakthrough Therapy, Accelerated Approval and Priority Review – all major parts of the FDA’s new mission to fulfill their mandate in an innovative manner. 

Working with clients who develop innovative treatments for serious and life threatening diseases, we at Treehill encounter the benefits attached to Fast Track status on a regular basis and believe the designation represents a key opportunity for sponsors to develop their drug “into the right direction” and including FDA’s perspective continuously throughout the development process.

A few details directly from the FDA on the designation:

  • Eligible clinical conditions need to be “serious” which is a matter of judgement based on lethality, affecting day-to-day functioning, or the likelihood of progression to a more serious state if left untreated. Examples include AIDS, Alzheimers, heart failure, cancer, but also epilepsy, depression, diabetes and many others.
  • Eligible therapy candidates need to “fulfil an unmet need” being defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy; which covers any drug being developed against a condition with no current treatment available, as well as therapies that have advantages in the areas of effectiveness, avoidance of side effects, improved diagnosis (if that improves outcomes), decreasing of treatment discontinuing toxicities, or such that address future public health needs
  • Benefits attached to Fast Track designation include some or all of the following:
  • More frequent FDA meetings regarding the drug development plan and data requirements for approval
  • More frequent FDA communication regarding trial designs and biomarkers
  • Eligibility for Accelerated Approval and Priority Review (subject to respective criteria)
  • Rolling Review, allowing submission of individual completed application sections rather than only submitting once consolidated file once all components are complete

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

To learn more about the FDA’s Fast Track program visit:

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