The problem of therapeutic use of unauthorised (investigational) drugs, always controversial, over recent years has become a topic of a particularly heated public debate. Most often referred to as expanded access (EA) or compassionate use, such treatment is usually performed in patients with serious including life-threatening diseases who cannot be treated satisfactorily with authorised drugs.
According to the recently published US Food and Drug Administration’s (FDA’s) data, the number of EA requests in the USA increased more than twofold between 2005 and 2014; these applications pertain to use of unauthorised drugs in a variety of medical specialties.