Physicians' Perspectives on FDA Approval Standards and Off-label Drug Marketing

Aaron S Kesselheim; Steven Woloshin; Zhigang Lu; Frazer A Tessema; Kathryn M Ross; Lisa M Schwartz

doi:10.1001/jamainternmed.2018.8121

Physicians' Perspectives on FDA Approval Standards and Off-label Drug Marketing

JAMA Intern Med. 2019 May 1;179(5):707-709. doi: 10.1001/jamainternmed.2018.8121.

Authors

Aaron S Kesselheim¹, Steven Woloshin², Zhigang Lu¹, Frazer A Tessema¹, Kathryn M Ross³, Lisa M Schwartz²

Affiliations

¹ Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
² The Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire.
³ The American Board of Internal Medicine, Philadelphia, Pennsylvania.

Abstract

This nationwide survey of US primary care internists and medical specialists evaluates physicians’ attitudes about the US Food and Drug Administration’s drug approval standards and off-label drug marketing.

Publication types

Letter
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Attitude of Health Personnel*
Drug Approval / statistics & numerical data*
Drug Labeling / standards
Female
Humans
Male
Middle Aged
Off-Label Use / statistics & numerical data*
Practice Patterns, Physicians' / statistics & numerical data*
United States
United States Food and Drug Administration