ARTICLE | Regulation

Viral crossroads

Hardy case shows flaws in compassionate use system, provides catalyst for change

March 31, 2014 7:00 AM UTC

Now that the family of seven-year-old Josh Hardy has successfully obtained access to an experimental drug, aided by an explosion of social media support, lawmakers, industry and patients still are left grappling with the fundamental inequities and flaws of the U.S. system for granting compassionate access to investigational therapies.

The problems have existed for years, including the idiosyncrasies of who gets access to investigational drugs outside of clinical trials and the criteria companies use to make decisions that are often life-and-death...