OBJECTIVES: From 2006 – 2013 the FDA approved 207 new molecular entities (NMEs), which included 84 efficacy statements supported by PRO assessments.  In addition to NMEs, many previously-approved product labels were updated with PRO statements during this period.  The purpose of this research was to review the efficacy claims supported by PROs to identify trends amongst the approved indications and differences between approved claims before and after finalization of the guidance.  METHODS: NME labels approved by the FDA from 2006 – 2013 were reviewed on the Drugs@FDA website; updated labels were discovered via literature and Internet searches.  An assessment or statement of efficacy was considered to be PRO-based if it assessed symptoms, side effects, or impacts on functioning and daily activities, entirely from the patient perspective.  RESULTS: From 2006 – 2013, the FDA approved an average of 25.9 NMEs per year.  The average number of PROs included in NME labels from 2006 – 2010 was 14.2 per year (n = 71).  From 2011 – 2013, the average was 4.3 PROs approved per year (n = 13).  The difference between these two periods is statistically significant (t = 4.85, p = .002).  Further investigation revealed 22 non-NME labels with PROs newly approved during this period, with no notable per-year trends.  CONCLUSIONS: The FDA’s PRO Guidance may not be the lone cause for the reduction of approved PROs in NME labels, but there was a significant drop in the number of approvals following its finalization.  While the number of PROs approved in 2010 was similar to the numbers approved 2006 – 2009, submissions reviewed in 2010 may not have been asked to meet the standards of the PRO Guidance, thus impacting our analysis.  Inclusion of non-NME labels approved from 2006 – 2013 does not increase the percentage of PROs approved.