Understanding the Intricacies of FDA PRO Labeling

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Interpreting the Trends of the Past 10 Years

Despite an increase in the number of new drugs approved by the US FDA and the increased focus on patient-centered drug development, a recent review showed that the percentage of new drug approvals by the FDA with PRO labeling has declined from about 24% during the period 2006-2010 to 16% between 2011 and 2015. Why should this be? RTI-HS researchers have conducted a study, A Review of Patient-Reported Outcome Labeling in the United States (2011-2015), to investigate possible reasons for this decline. This study was published today in Value in Health.

Their research showed that this decline was mainly due to the recent increase in drug approvals in diseases that traditionally do not require PROs for regulatory decision making, such as infectious diseases and cancers. However, PRO labeling on new drug approvals for drugs that do traditionally require PROs has remained the same–around 47% over the past 10 years. The research suggests room for increased PRO labeling, especially for drug approvals that traditionally use PROs for regulatory decision making.

The study also showed that the majority of FDA approved PRO labeling was for symptoms closely related to the disease (primary objectives), and that there was no labeling for concepts such as treatment satisfaction or work productivity. PRO labeling related to non-primary study objectives were only granted to a handful of new drug approvals.

RTI Health Solutions has created a webinar that will explore the trends in PRO-related product labeling and highlight some key observations found during the review. Our experts in patient-centered outcomes and market access strategy have a conversation about their findings. They will cover what you need to know as you gather evidence about your product, and answer questions about PRO labeling strategy.

Other related research:

A Review of Patient-Reported Outcome Labels in the United States: 2006 to 2010. Gnanasakthy A, Mordin M, Clark M, DeMuro C, Fehnel S, Copley-Merriman C.

FDA Patient-Reported Outcomes Pro Labeling Over the Last-10 Years. Ari Gnanasakthy, MBA, MSc, Principal Scientist of Patient-Centered Outcomes Assessment at RTI-HS discusses changes in FDA PRO labeling during an eCOA forum lecture.

Patient-reported outcomes labeling for products approved by the office of hematology and oncology products of the US Food and Drug Administration (2010-2014). Gnanasakthy A, DeMuro C, Clark M, Haydysch E, Ma E, Bonthapally V. 

FDA patient-reported outcome labeling of novel therapies (2011-2015)Gnanasakthy A, Mordin M, Haydysch E, DeMuro C

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