Abstract
This note analyzes the regulation of experimental drugs by the FDA within the context of “right-to-try” laws. Hogan explores the FDA’s drug approval process, highlighting the specific options for terminally ill patients to fast-track their access to potentially life-saving drugs. Hogan then turns to state “right-to-try” laws, addressing them in relation to federal preemption, pharmaceutical companies, and actual assistance to terminally ill patients. Hogan recommends a relaxation of the FDA’s drug approval process, specifically streamlining the “expanded access” program to give terminally ill patients access to experimental drugs.
Keywords: Right to try, Legislation, FDA, Drug approval process, Federal preemption, Pharmaceutical companies, Terminally ill, Experimental drugs, Regulation
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