Compassionate Use Access to Experimental Drugs and The Misguided Mission of Right-To-Try Laws

from Health Affairs Blog

Some patients facing death take drastic, or even desperate measures in order to prolong their lives. Such actions often include taking unapproved, investigational drugs. In the U.S., a program known as Compassionate Use, or Expanded Access, allows terminally ill patients who meet certain medical criteria to apply (through their physicians) to the Food and Drug Administration (FDA) and the drug manufacturers for access to drugs that are undergoing FDA clinical trials. At first blush, it may appear that there should be no legal, political, or ethical controversies surrounding the concept of expanded access. How can one possibly deny a dying patient even the slightest chance of prolonged life or recovery? Is there a side effect worse than certain death?

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