Comparative Effectiveness Research at the FDA: Taking the “Person” out of Personalized Medicine?

Abstract

of federal funds to comparative effectiveness research (CER), a government project aimed at enhancing efficiency in federal spending by assessing the relative effectiveness of available treatment options across populations. A great deal of literature attempts to predict the likely impact of CER, which is intended to study effectiveness among populations or subgroups, and PM, which focuses on effectiveness in the individual. The general consensus is that the impact will be a positive one, with both strategies mutually enhancing the quality of medical treatment for each individual. Few have expounded upon the effects of CER on PM at the FDA in particular, however. This paper explores some of the ways in which CER may interact with the FDA’s stated goal of furthering PM. It concludes that in spite of certain practical limitations on the symbiotic coexistence of PM and CER, CER is unlikely to obstruct the FDA’s pursuance of PM.