Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012.

ABSTRACT:

Importance

Pharmaceutical manufacturers can receive 6 additional months of market exclusivity for performing pediatric clinical trials of brand-name drugs widely used in adults. Congress created this incentive in 1997 because these drugs were being used off-label in children without such trials.

Objective

To review updates to drug labeling and the cost to consumers of extending market exclusivity related to the pediatric exclusivity program.

Design

From government records, we identified 54 drugs that earned the pediatric exclusivity incentive between 2007 and 2012. We evaluated labeling changes from the pediatric studies. We then extracted trial details from clinical review documents and used industry estimates of trial costs on a per-patient basis to estimate cost of

SUBMITTER: Sinha MS 

PROVIDER: S-EPMC6248195 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature