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Journal of General Internal Medicine

, Volume 35, Issue 1, pp 377–379 | Cite as

Reporting of Drug Benefit in FDA-Approved Prescription Drug Labeling

  • Bansri Desai
  • Kyungwan Hong
  • John H. PowersIII
  • Peter DoshiEmail author
Article

INTRODUCTION

Obtaining an accurate understanding of the known benefits and risks of drugs is difficult, particularly when drugs first come to market. The most robust evidence is largely limited to pre-marketing studies (e.g., phase 3 trials), but the peer-reviewed literature describing these studies may be incomplete (e.g., with unpublished trials), and systematic reviews often have yet to be conducted. Despite their reputation as unhelpful, FDA-approved prescribing information (also known as “package inserts” or “drug labels”) should provide clinicians with a trustworthy source of information about new drugs that has been independently vetted.

Previous research has assessed the quality of clinical trial evidence supporting recent FDA-approved therapeutic agents;1however, how this information is reported to prescribers through drug labels has not been evaluated. Per guidance, labels are supposed to include key efficacy information including the magnitude of treatment benefit, i.e.,...

Notes

Data Sharing

All data we extracted and coded, as well as copies of original drug labels used in our study, are freely available in the Zenodo repository ( https://doi.org/10.5281/zenodo.2562183).

Author Contributions

All authors had full access to all of the data in the study and take responsibility of the integrity of the data and the accuracy of the data analysis.

Study concept and design: Desai, Doshi

Acquisition of data: All authors

Analysis and interpretation of data: All authors

Drafting of the manuscript: Desai, Doshi, Powers

Critical revision of the manuscript for important intellectual content: All authors

Statistical analysis: Desai

Administrative, technical, or material support: Doshi

Study supervision: Doshi

Funding Information

This study was funded with nonspecific faculty research funds provided by the University of Maryland, Baltimore, to Dr. Doshi.

Compliance with Ethical Standards

Conflict of Interest

Dr. Doshi has received travel funds from the European Respiratory Society (2012) and Uppsala Monitoring Center (2018) and grants from the Laura and John Arnold Foundation (2017–2021), American Association of Colleges of Pharmacy (2015), Patient-Centered Outcomes Research Institute (2014–2016), Cochrane Methods Innovations Fund (2016–2018), and UK National Institute for Health Research (2011–2014) and is an editor at The BMJ and an unpaid member of the Reagan-Udall Foundation for the FDA. Dr. Powers reports personal fees from Abbvie, Cardeas, Cempra, Contrafect, Gilead, Johnson & Johnson, MedImmune, Novartis, Otsuka, Pfizer, Roche, Romark, and Trius outside the submitted work. Dr. Desai and Dr. Hong have no interests to declare.

References

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    Food and Drug Administration. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/default.htm. Accessed 17 Sept 2019.
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    AHFS Classification - Drug Assignments and Reassignments. http://ahfs.ashp.org/drug-assignments.aspx. Accessed 17 Sept 2019.
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Copyright information

© Society of General Internal Medicine 2019

Authors and Affiliations

  • Bansri Desai
    • 1
  • Kyungwan Hong
    • 1
  • John H. PowersIII
    • 2
  • Peter Doshi
    • 1
    Email author
  1. 1.Department of Pharmaceutical Health Services Research University of Maryland School of PharmacyBaltimoreUSA
  2. 2.George Washington University School of MedicineWashingtonUSA

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