The debate concerning the off-label prescriptions of drugs: a comparison between Italian and U.S. law

Authors: Benedetta Guidi, Luca Nocco


So-called off-label drug prescription is the administration of a registered medicine or medical device that is not included nor disclaimed in the product information.

In this paper we deepen the questions arising from the above-mentioned medical practice from a legal and medico legal point of view, illustrating what is meant by off-label prescription and the reasons for the growth of this phenomenon, as well as the procedure for authorising drugs and for administer off label treatments in Italian and American law.

Finally, we try to summarise short conclusive reflections about the differences between the two above mentioned legal systems, as well as about the unavoidable role of off label prescriptions in current medical practice, concluding that, under a seeming paradox, scientific uncertainty will lead to an increase of off label uses.