Gnanasakthy A, Doward L, Clark M, Mordin M, DeMuro C. Concordance of pro labeling claims between the FDA and EMA. Poster presented at the 2012 ISPOR 15th Annual European Congress; November 9, 2012. Berlin, Germany. [abstract] Value Health. 2012 Nov; 15(7):A321.

OBJECTIVES: Recent reviews have examined differences in PRO label claims comparing U.S Food and Drug Administration (FDA) decisions to those in the European Medicines Agency (EMA). Limited research has been conducted to identify where there is concordance between agency decisions in PRO labeling. This analysis sought to discover instances where similar PRO labels were granted by each agency to determine if there are precipitating factors that would increase the likelihood of claims being granted by both.

METHODS: AA listing of drug approvals granted by both the FDA and EMA was generated, identifying a total of 75 products (2006-2010). PRO claims found in US Drug Approval Packages and European Public Assessment Reports packages were compared to detect any similarities or differences in claims made for the same product by the same company. For analysis purposes, PRO claim type was categorized as symptoms, functioning, HRQOL, patient global rating (PGR), or other.

RESULTS: A total of 75 products were approved by both agencies. Of these, a total of 35 (47%) were granted at least one PRO claim by the EMA as compared to 14 (19%) by the FDA. Of the 14 products with PRO claims granted by both agencies, only a small number (n4, 11%) had the same claim types granted, without deviation. Despite these discrepancies, upon dissection of the labels, commonalities were identified. Symptom claims were granted in 12 of 14 products by both agencies as were 5 functioning and 3 PGR claims.

CONCLUSIONS: While PRO label claims do not demonstrate perfect agreement between agencies, upon close examination there appears to be greater concordance then previously recognized. Precipitating factors such as therapeutic area, PRO measure or order of regulatory submission may influence the agreement between agencies. Further investigation is warranted to better support effective PRO strategies.

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