New Clinical Information and Physician Prescribing: How Do Pediatric Labeling Changes Affect Prescribing to Children?

Health Economics. 30(1), January 2021, 144-164. https://doi.org/10.1002/hec.4182

Posted: 25 Feb 2021

See all articles by Mary K. Olson

Mary K. Olson

Tulane University

Nina Yin

Central University of Finance and Economics (CUFE) - China Center for Human Capital and Labor Market Research; Tulane University

Date Written: November 3, 2020

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

JEL Classification: I18, L5, O3

Suggested Citation

Olson, Mary K. and Yin, Nina, New Clinical Information and Physician Prescribing: How Do Pediatric Labeling Changes Affect Prescribing to Children? (November 3, 2020). Health Economics. 30(1), January 2021, 144-164. https://doi.org/10.1002/hec.4182, Available at SSRN: https://ssrn.com/abstract=3728748

Mary K. Olson (Contact Author)

Tulane University ( email )

Department of Economics
306 Tilton Hall
New Orleans, LA 70118
United States
504 862-8342 (Phone)
504 865-5869 (Fax)

Nina Yin

Central University of Finance and Economics (CUFE) - China Center for Human Capital and Labor Market Research ( email )

Room 609 Academic Hall
39 South College Road
Beijing, 100081
China

Tulane University ( email )

6823 St Charles Ave
New Orleans, LA 70118
United States

Do you have a job opening that you would like to promote on SSRN?

Paper statistics

Abstract Views
159
PlumX Metrics