Note

“Right to Try” Legislation and Its Implications for the FDA Drug Approval Process

Author: Emily Hogan (Washington University School of Law)

  • “Right to Try” Legislation and Its Implications for the FDA Drug Approval Process

    Note

    “Right to Try” Legislation and Its Implications for the FDA Drug Approval Process

    Author:

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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Published on
01 Jan 2016