The drug development process—regulated by the U.S. Food and Drug Administration (FDA)—is complex, lengthy, and costly. For years, reformers have sought more liberal access to potential drug treatments that have not yet reached the final stages of the process. “Right to Try” laws and the FDA’s expanded access program are among some of the government measures designed to allow terminally ill patients to obtain investigational drugs before they receive FDA approval. This Article explores the strengths and shortcomings of some of the measures undertaken by state and federal governments, while highlighting the policy struggle between providing individuals early access to potentially life-saving drugs and maintaining the necessary government oversight to ensure consumer safety.
Alissa Bang, HEALTH LAW—A HARD PILL TO SWALLOW: AN EXAMINATION OF THE U.S. DRUG DEVELOPMENT PROCESS AND STATE AND FEDERAL GOVERNMENT MEASURES TO EXPAND PATIENT ACCESS TO INVESTIGATIONAL DRUGS, 42 W. New Eng. L. Rev. 169 (2020), https://digitalcommons.law.wne.edu/lawreview/vol42/iss2/1