Document Type


Publication Date

Fall 2018


Innovation does not stop when new medicines are launched. Companies with approved drugs and biologics continue to study their products for years after the initial approval-for instance, exploring new ways to formulate their drugs or modifying the active ingredients to introduce versions with different, and sometimes better, safety and effectiveness profiles. They also routinely study their products for usefulness in treating new conditions. This continued research requires time and money, and companies will not invest that time and money without adequate reason to do so. This Article examines the incentives federal law provides for new-use research, concluding that current incentives are little more than paper promises.



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