OBJECTIVES: To determine the influence of the FDA Draft PRO Guidance on obtaining PRO label claims, for drug products in the US, since its release in February 2006.
METHODS: Package inserts (indication, clinical trials sections) and medical review sections from publicly available summary basis of approvals (SBA) for FDA approved drug products named by the MAPI PROLabels database as having a US-based PRO label claim between February 2006 and August 2008 were reviewed.
RESULTS: Of 33 products reviewed, 44 PRO claims were granted. Signs and symptoms (SS) represented the majority (n = 32; 73.7%) of the claims. Within this category, the greatest number of claims were pain-related (primarily based on a VAS or NRS rating scale) and more than half of all SS claims were based on a patient diary. After SBA review for the 24 drug products identified with an available medical review, 13 products were found to have collected additional PRO within the context of the registration trial (reported in the medical review) that did not result in a PRO claim; of these, 6 had PROs reported to have statistically significant results and 2 of these (Voltaren and Fentora) reported clinically meaningful results. Both products were reviewed by the same FDA Division of Anesthesia, Analgesia, & Rheumatology (DAAR) and are indicated for pain. Of the 33 products reviewed, the Pulmonary and Allergy Products reviewing division reviewed the most products (nine) and allowed the most PRO claims (eleven) in the label. Of the 33 products reviewed, SEALD was involved in 4 product SBA reviews.
CONCLUSIONS: Evidence suggests that since the release of the Draft PRO Guidance, many PRO claims continue to be approved by FDA reviewing divisions; however, the reviewing divisions are not always adhering to the current standards when assessing PRO data for a claim.
