Is there a legal basis for the FDA to use biomarkers in the evaluation of new drugs and devices?
Yes. The Food and Drug Administration Modernization Act of 1997 (FDAMA) contains provisions promoting the use of “surrogate endpoints,” implicitly including biomarkers, in the evaluation of drugs. Specifically, FDA may approve drugs intended to treat serious or life-threatening conditions based on a surrogate endpoint that demonstrates a reasonable likelihood of clinical benefit. Importantly, eligible conditions are not restricted to HIV or cancer, but include any disease that affects day-to-day functioning, or a condition that, if left untreated, would likely progress to a more serious one. This definition is broad enough to encompass a great many medical conditions. While FDAMA device provisions do not specifically address surrogate markets, they do require FDA to use the “least burdensome means” necessary when approving or clearing a device for market. This provision is believed to implicitly include the use of biomarkers in imaging.
