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Tytuł pozycji:

Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases.

Tytuł:
Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases.
Autorzy:
Liu S; Brigham and Women's Hospital/Harvard Medical School.
Mello MM; Stanford University.
Kesselheim AS; Brigham and Women's Hospital/Harvard Medical School.
Źródło:
Journal of health politics, policy and law [J Health Polit Policy Law] 2021 Jun 01; Vol. 46 (3), pp. 487-504.
Typ publikacji:
Journal Article
Język:
English
Imprint Name(s):
Original Publication: Durham, N. C., Duke Univ. Press.
MeSH Terms:
Jurisprudence*
Pharmaceutical Preparations*
Civil Rights/*legislation & jurisprudence
Marketing/*legislation & jurisprudence
Off-Label Use/*legislation & jurisprudence
United States ; United States Food and Drug Administration/legislation & jurisprudence
Contributed Indexing:
Keywords: commercial speech; prescription drug marketing; prescription drugs
Substance Nomenclature:
0 (Pharmaceutical Preparations)
Entry Date(s):
Date Created: 20210301 Date Completed: 20210820 Latest Revision: 20210820
Update Code:
20240105
DOI:
10.1215/03616878-8893571
PMID:
33647951
Czasopismo naukowe
Context: Food and Drug Administration (FDA) rules restrict pharmaceutical manufacturers from promoting drugs for non-FDA-approved (off-label) indications. When manufacturers violate this rule, it has in many cases led to unsafe prescribing. However, in 2012, a federal circuit court ruled in United States v. Caronia that truthful off-label promotion was protected under the First Amendment, threatening government enforcement in this area.
Methods: The authors extracted cases from the WestLawNext database that mentioned Caronia from 2012 to 2019. They collected information about plaintiff, procedural history, product and manufacturer involved, and case outcome. Cases were categorized as either "follows," "does not follow," or "distinguishes" from Caronia. The authors qualitatively reviewed the full text of each case to verify whether Caronia was given substantive discussion for perceptions of off-label promotion, application of commercial speech rights, and how courts interpreted Caronia.
Findings: Among 42 cases in the study cohort, 22 (52%) followed Caronia's core holding that truthful, non-misleading off-label promotion was not actionable under FDA rules. By contrast, 20 cases (48%) treated Caronia negatively, either declining to follow (9 cases) or distinguishing it (11 cases).
Conclusions: Enforcement of restrictions on off-label marketing became more challenging after Caronia. This gives manufacturers greater flexibility to promote drugs for unapproved uses despite the substantial public health risks.
(Copyright © 2021 by Duke University Press.)

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