The FDA’s compassionate-use program is at the center of a debate about access to unapproved drugs. Darcy Olsen, chief executive officer of the Goldwater Institute, makes the case for easier access to compassionate use of new drugs. Only 1,400 Americans a year are granted early access to promising treatments through compassionate use. The FDA’s rules have evolved over time to accommodate new drugs and treatments. To truly help patients seeking access to unapproved drugs, we need efforts that will help physicians understand this process, help them and their patients identify promising drugs, and give them insight into what makes companies more or less inclined to grant patients access to products.
Source: Wall Street Journal April 12, 2017 02:02 UTC