‘ I ’m Willing To Try Anything ’ : Compassionate Use Access To Experimental Drugs And The Misguided Mission Of Right-To-Try Laws

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? Beneath its seemingly altruistic and uncontroversial veneer, the Compassionate Use program has been a lightning rod for intense legal, legislative, and public policy controversies, many of which have been framed as “libertarian vs. regulatory” battles between those who wish to allow patients freer, even unrestricted, access to experimental drugs (often by changing or limiting the role of the FDA), and those who prefer a more measured, rigorous approach to dispensing unproven and potentially dangerous therapies. One of the most highly publicized manifestations of this controversy has been the passage of Right-To-Try Laws in 33 U.S. states (as well as current bills before the U.S. House of Representatives and Senate), which see...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Drugs and Medical Technology End of Life & Serious Illness Compassionate Use expanded access FDA pharmaceutical companies right-to-try laws Source Type: blogs