Expanding Patient Access to Investigational Drugs: Single Patient Investigational New Drug and the "Right to Try".

ABSTRACT: With drug approval times taking an average of 8 years from entry into clinical trials to full U.S. Food and Drug Administration (FDA) approval, patients with life-threatening and severely debilitating disease and no reasonable therapeutic options are advocating for expanded access (EA) to investigational drugs prior to approval. Special investigational new drug (IND) application categories allow patients who meet specific criteria to receive treatment with non-approved drugs. The FDA approves over 99% of all single-patient INDs, providing emergency approval within hours, and non-emergency approval within an average of 4 days. "Right-to-try" laws passed in 38 states would allow patients to bypass FDA processes altogether, but contain controversial provisions that some claim risk more harm t

SUBMITTER: Van Norman GA 

PROVIDER: S-EPMC6059004 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature