New clinical information and physician prescribing: How do pediatric labeling changes affect prescribing to children?

Abstract

Our study examines how physician prescribing responds to new scientific information added to drug labels. We focus on a series of label changes with new information about the effects of drugs in children. The information arose in response to a 1997 policy, pediatric exclusivity, which gave drug sponsors a 6-month exclusivity extension for conducting additional pediatric studies of already marketed drugs. The information from these studies was expected to improve pediatric prescribing by promoting appropriate use and by reducing inappropriate off-label prescribing. However, there has been little study about the actual effects of these labeling changes on physician prescribing behavior. We use a difference-in-differences strategy to examine how pediatric prescriptions respond to different types of labeling changes. Our results show that most label changes lead to reductions in prescribing to children. We find that the largest drop in prescribing occurs when the label indicates a drug is not effective for children. The evidence suggests that the labeling changes alleviated physician uncertainty about prescribing drugs to children and reduced some inappropriate off-label use.

Keywords: FDA regulation; innovation policy; market incentives; pediatric exclusivity; pharmaceuticals.