An article published in Value in Health analyzed patient reported outcome labeling (PRO) of drugs approved by Food and Drug Association during 2011 to 2015. They also compare the findings with those reported between 2006 and 2010, before FDA released its final guidance for industry on the use of PROs to support labeling claims. PRO is utilized to measure treatment benefit by formally obtaining the view of patients. Patient opinion is often used as primary end-points in clinical trials to assess effectiveness.
The authors found that during the 2011-2015 period, out of the 182 newly approved drugs, a quarter of them had PRO labeling which was mostly based on primary end points and some of them were based on secondary end points. They also report that was an overall decline in PRO labeling 2011 to 2015 compared to 2006 to 2010 but was similar for drugs that traditionally rely on PROs for assessing treatment benefit. According to the authors “it is in the interest of drug manufacturers to provide high quality data to regulators, payers, and prescribers to maximize the value of products and fully inform patients” and both the sponsors and the FDA should work towards better PRO reporting strategy.