In an effort to help terminally ill patients bypass the FDA's arduous, time-consuming approval process and have quicker access to potentially life-saving drugs, states across the country have passed "right to try" acts. These state acts allow a terminally ill patient the right to access an investigational drug that has completed initial safety testing, known as Phase I, but that has not been approved by the FDA. The reasoning behind these acts is that terminally ill patients, with the guidance and counsel of their physicians, should have the choice whether to pursue an unapproved drug, rather than placing their fate and survival in the hands of the FDA, a complex governmental bureaucracy operating on its own timeframes. This reasoning appears to align with the mindset of most Americans; however, the right to try acts have also been subject to intense criticism regarding whether the acts will be effective in granting terminally ill patients greater access to investigational drugs. This article analyzes whether the right to try acts will be effective in achieving their purpose of greater access for terminally ill patients. To provide context for the right to try acts, Part I of this article outlines the current FDA drug approval process and discusses the FDA's compassionate use program along with its inherent problems. Part II of the article reviews the right to try acts found in many states, with an analysis of the specific provisions of those acts. Part III of the article considers the criticisms voiced by legal and medical scholars, and analyzes whether those criticisms have validity, concluding that a federal right to try statute would likely be more effective. Part IV contemplates the enactment of a federal right to try statute and reviews federal right to try legislation that has previously been introduced to Congress.
45 S.W. L. Rev. 719 (2016)