A proposed rule clarifying when manufacturers would have to update product labeling to reflect unapproved uses of their medicines has been issued by the Food and Drug Administration, ending decades of controversy. By doing so, the FDA is leaving intact a decades-old rule that requires drugmakers to update labeling if there is evidence to suggest that a company intended its medicine to be used for unapproved uses. While doctors are free to prescribe a drug for any purpose as they see fit, courts have ruled that drugmakers can only make statements about off-label uses provided the information is truthful and not misleading. Read the full story here.
(Source: Ed Silverman, STAT News, September 23, 2020)