title: A Review of Patient-Reported Outcome Labeling in the United States (2011-2015).
abstract: BACKGROUND
  A review of new drug approvals (NDAs) by the Food and Drug Administration (FDA) for 2006 to 2010 showed that 24.1% of new drugs had patient-reported outcome (PRO) labeling.
  
  
  OBJECTIVE
  To review PRO labeling for NDAs for 2011 to 2015 and to compare key findings reported previously.
  
  
  METHODS
  A review of the FDA drug approval reports for NDAs was conducted using the FDA Web site to determine the number of NDAs for the period 2011 to 2015. For all identified NDAs, drug approval package and product labeling were reviewed to identify PRO end-point status and PRO labeling. NDAs for the period 2006 to 2015 were grouped by disease category as per the International Classification of Diseases, Tenth Revision. Data were summarized for all NDAs and for approvals in diseases that traditionally rely on PROs for evaluating treatment benefit (PRO-dependent). Results were compared with NDAs for the period 2006 to 2010.
  
  
  RESULTS
  In the period 2011 to 2015, 16.5% of the 182 NDAs had PRO labeling. For PRO-dependent NDAs, this figure was 46.9% and 46.0% for the period 2006 to 1010 and the period 2011 to 2015, respectively. Most of the PRO labeling for the period 2011 to 2015 was based on primary end points (76.7%). Almost all PRO labeling was for concepts proximal to the disease.
  
  
  CONCLUSIONS
  There is potential for increased PRO labeling, especially for drug approvals in diseases that traditionally rely on PROs for evaluating treatment benefit to satisfy regulatory needs. Less PRO labeling based on secondary end points may be indicative of drug manufacturers' reluctance to aid and enhance the value propositions of their products to all stakeholders, including patients.
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC, USA. Electronic address: gnanasakthy@rti.org.
authors.forename: Ari
authors.initials: A
authors.lastname: Gnanasakthy
authors.affiliation: RTI Health Solutions, Ann Arbor, MI.
authors.forename: Margaret
authors.initials: M
authors.lastname: Mordin
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC, USA.
authors.forename: Emily
authors.initials: E
authors.lastname: Evans
authors.affiliation: RTI Health Solutions, Manchester, UK.
authors.forename: Lynda
authors.initials: L
authors.lastname: Doward
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC, USA.
authors.forename: Carla
authors.initials: C
authors.lastname: DeMuro
mesh_terms: D002908:Chronic Disease / Q000188:drug therapy; D017277:Drug Approval / Q000706:statistics & numerical data*; D004348:Drug Labeling / Q000706:statistics & numerical data*; D006801:Humans; D000071066:Patient Reported Outcome Measures; D055553:Prescription Drugs / Q000627:therapeutic use; D011356:Product Labeling; D035583:Rare Diseases / Q000188:drug therapy; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D055553:Prescription Drugs
keywords: FDA; PRO labeling; drug labeling; patient-reported outcomes