eprintid: 48146
rev_number: 8
eprint_status: archive
userid: 1482
importid: 105
dir: disk0/00/04/81/46
datestamp: 2023-08-23 05:48:19
lastmod: 2023-08-31 07:34:48
status_changed: 2023-08-23 05:48:19
type: monograph
metadata_visibility: show
creators_name: Dubois, Pierre
creators_name: Gentry, Elissa
creators_name: Tunçel, Tuba
creators_idrefppn: 172637546
creators_idrefppn: 221735526
creators_affiliation: Florida State University
creators_affiliation: Florida State University
creators_halaffid: 1002422
title: Strategic Submissions : A Cross-Country Analysis of Supplemental Drug Approvals
ispublished: pub
subjects: subjects_ECO
abstract: Off-label use regulation has the potential to change pharmaceutical rms' behavior and|consequently|affect patient welfare. We investigate the impact of two changes in off-label regulation on pharmaceutical rms' behavior in seeking formal marketing approval for supplementary uses. In 2012, a US court decision protected truthful o-label promotion, providing pharmaceutical companies more leeway to promote o- label uses of their drug. Similarly, in 2011, France passed a new system for monitoring o-label uses in anticipation of formal approval. Using a unique data set of pharma- ceutical rms' research and development projects, we exploit these regulatory changes to understand how rms react to government policies. Results demonstrate that rms esponded to the US policy providing lower incentives to submit supplemental uses for formal approval. The results do not evince any reaction to France's stringent|but poorly enforced|regulation. These results have implications not only for innovation policy but for the creation of high-quality data for certain indications.
date: 2023-07
date_type: published
publisher: TSE Working Paper
official_url: http://tse-fr.eu/pub/128335
faculty: tse
divisions: tse
language: en
has_fulltext: TRUE
view_date_year: 2023
full_text_status: public
monograph_type: working_paper
series: TSE Working Paper
volume: 23-1459
place_of_pub: Toulouse
pages: 45
institution: Université Toulouse Capitole
department: Toulouse School of Economics
book_title: TSE Working Paper
oai_identifier: oai:tse-fr.eu:128335
harvester_local_overwrite: department
harvester_local_overwrite: pending
harvester_local_overwrite: creators_idrefppn
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oai_lastmod: 2023-08-01T01:30:42Z
oai_set: tse
site: ut1
citation:   Dubois, Pierre <https://www.idref.fr/172637546>, Gentry, Elissa and Tunçel, Tuba <https://www.idref.fr/221735526>  (2023) Strategic Submissions : A Cross-Country Analysis of Supplemental Drug Approvals.  TSE Working Paper, n. 23-1459, Toulouse     
document_url: https://publications.ut-capitole.fr/id/eprint/48146/1/wp_tse_1459.pdf