Concepedia

Off-label Promotion Liability

Off-Label Promotion Liability is a form of legal liability arising in pharmaceutical product liability law wherein a manufacturer is held accountable for promoting a drug for uses not approved by regulatory authorities, thereby distinguishing it from permissible marketing practices confined to approved indications.

11

Publications

319

Citations

19

Authors

14

Institutions

Publications per year

2017–2026

0

Parents

Publications

11

Shifting Terrain in the Regulation of Off-Label Promotion of Pharmaceuticals

Michelle M. Mello, David M. Studdert, Troyen A. Brennan · New England Journal of Medicine · 2009 · 59 citations

, , +16

Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003–2012

Andreas Vilhelmsson, Courtney Davis, Shai Mulinari · PLoS Medicine · 2016 · 44 citations · Full text

, , +16

False Claims Act Prosecution Did Not Deter Off-Label Drug Use In The Case Of Neurontin

Aaron S. Kesselheim, Devan L. Darby, David M. Studdert et al. · Health Affairs · 2011 · 38 citations

, , +14

Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs.

James O’Reilly, Amy Dalal · PubMed · 2003 · 36 citations · Full text

, , +16

Pharmaceutical Promotion to Physicians and First Amendment Rights

Aaron S. Kesselheim, Jerry Avorn · New England Journal of Medicine · 2008 · 35 citations

, , +15

1–5 of 11

Authors

19

  1. JA
    Jerry Avorn

    Brigham and Women's Hospital, United States

    3 publications · 84 citations

    3

    h-index

  2. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    3 publications · 84 citations

    3

    h-index

  3. DM
    David M. Studdert

    The University of Melbourne, Australia

    2 publications · 97 citations

    2

    h-index

  4. MM
    Michelle M. Mello

    Harvard University, United States

    2 publications · 70 citations

    2

    h-index

  5. MA
    Mark A. Ratner

    Northwestern University, United States

    1 publications · 18 citations

    1

    h-index

1–5 of 19

Institutions

14

  1. Brigham and Women's Hospital

    Boston, United States

    3 h-index

    6 publications

    195 citations

  2. Harvard University

    Cambridge, United States

    3 h-index

    4 publications

    140 citations

  3. Boston University

    Boston, United States

    2 h-index

    2 publications

    69 citations

  4. Flinders University

    Adelaide, Australia

    1 h-index

    2 publications

    26 citations

  5. Catholic Medical Center

    Manchester, United States

    1 h-index

    1 publications

    38 citations

  6. Population Council

    New Delhi, India

    1 h-index

    1 publications

    38 citations

  7. University of Wisconsin–Milwaukee

    Milwaukee, United States

    1 h-index

    1 publications

    27 citations

  8. The University of Melbourne

    Melbourne, Australia

    1 h-index

    1 publications

    59 citations

1–8 of 14

Venues

  1. New England Journal of Medicine

    NEJM · 3 publications · 104 citations

    3

    h-index

  2. PubMed

    Repository · 2 publications · 64 citations

    2

    h-index

  3. The Journal of Nervous and Mental Disease

    1 publications · 13 citations

    1

    h-index

  4. PLoS Medicine

    1 publications · 44 citations

    1

    h-index

  5. The Hastings Center Report

    1 publications · 27 citations

    1

    h-index

1–5