Fast Track (Approval)

The normal new drug application or IND process can be protracted, there has been considerable controversy about the resulting delay in providing potentially new drugs to victims of chronic degenerative or terminal diseases, i.e., by the time the drug is approved they may be dead or unlikely to benefit. In response drug regulatory agencies, in particular the United States FDA, have developed faster approval processes for such drugs.

The U.S. version, known as Fast Track, is intended for the combination of a product (usually a drug) and a claim that the product addresses an unmet medical need. The benefits of Fast Track include scheduled meetings to seek FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints, (i.e., information that can be used to make an educated guess at the endpoint of actual trials were they to be conducted in the long term, which is then substituted for by information derived from long-term monitoring of the drug after market approval). A surrogate endpoint is described as

“a laboratory or physical sign that is used in therapeutic trials as a substitute for a clinically meaningful endpoint that is a direct measure of how a patient feels, functions, or survives and that is expected to predict the effect of the therapy.”

However, while surrogate endpoints have always been used where there is a direct and established causal relationship between a condition and a result, e.g., high blood pressure and stroke, the fast track rule allows reliance on more tenuous predictors for an endpoint, by defining allowing in Fast Track use of a

“surrogate endpoint that, while ‘reasonably likely’ to predict clinical benefit, is not so well-established as the surrogates ordinarily used as bases of approval in the past”
(Fed. Reg. 58942 at 58944 (December 11, 1992)).

Fast track was established under the Food and Drug Administration Modernization Act of 1997, 21 U.S.C. §21. Obtaining Fast Track approval is regarded as a major event for a pharmaceutical company by financial markets and may cause rapid share price appreciation. The downside is that there is at least anecdotal evidence that drugs approved under Fast Track have a higher rate of complications leading to withdrawal from the market, creating a higher post-marketing level of risk.

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