Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs

Author:

Balogh Erin P.1,Bindman Andrew B.2,Eckhardt S. Gail3,Halabi Susan4,Harvey R. Donald5,Jaiyesimi Ishmael6,Miksad Rebecca7,Moses Harold L.8,Nass Sharyl J.1,Schilsky Richard L.9,Sun Steven10,Torrente Josephine M.11,Warren Katherine E.12

Affiliation:

1. Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine, Washington, DC, USA

2. University of California, San Francisco, California, USA

3. University of Texas at Austin's Dell Medical School, Austin, Texas, USA

4. Duke University, Durham, North Carolina, USA

5. Emory University, Atlanta, Georgia, USA

6. Beaumont Hospital, Royal Oak, Michigan, USA

7. Flatiron Health, New York, New York, USA

8. Vanderbilt University, Nashville, Tennessee, USA

9. American Society of Clinical Oncology, Alexandria, Virginia, USA

10. Janssen Research and Development, Raritan, New Jersey, USA

11. Hyman, Phelps & McNamara, P.C., Washington, DC, USA

12. Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts, USA

Abstract

Abstract A number of important drugs used to treat cancer—many of which serve as the backbone of modern chemotherapy regimens—have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of considerations for labeling updates, including selecting priorities for updating; data sources and evidentiary criteria; as well as the risks, challenges, and opportunities for iterative review to ensure prescribing information for oncology drugs remains relevant to current clinical practice.

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

Reference27 articles.

1. Outdated prescription drug labeling: How FDA-approved prescribing information lags behind real-world clinical practice;Shea;Ther Innov Regul Sci,2018

2. Enhancing information about older prescription drugs. Washington, DC: Friends of;Green;Cancer Research,2017

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