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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. Has the FDA approved drugs or devices for market using biomarkers in imaging? Yes. Numerous drugs for oncology have been approved using imaging biomarkers. In a recent publication by the FDA examining the criteria used for oncology drug approvals between 1990 – 2002 by the FDA’s Center for Drug Evaluation and Research, a majority of the drugs were found to be approved on the basis of imaging surrogate endpoints (see J. R. Johnson, G. Williams, R. Pazdur, “End points and United States Food and Drug Administration Approval of Oncology Drugs,” J. Clinical Oncology, 21(7), 1404-11, 1 April 2003). Numerous non-oncology examples also exist, including Betaseron, a drug designed to treat multiple sclerosis, was approved largely on the basis of MRI images that demonstrated improvement in brain lesions believed to be associated with the disease. FDA's press release announcing the approval of Betaseron may be found at: http://www.fda.gov/bbs/topics/NEWS/NEW00424.html | Home | About Us | Biomarkers Catalog | Center Membership | FAQs | Useful Links | |
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