A recent review (Gnanasakthy, 2012) has shown that about 24% of New Drug Applications (NDAs) and Biologic License Applications (BLAs) approved by the Food and Drug Administration (FDA) between 2006 and 2010 had at least one patient-reported outcome (PRO) label claim, and most claims (74%) were granted for PRO endpoints that were also primary endpoints. Claims based on primary endpoints are likely to be fully promoted by the manufacturers; however, the extent to which manufacturers promote claims based on secondary PRO endpoints is unknown.
