Healthy Skepticism Library item: 13600
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Psaty BM, Ray W.
FDA guidance on off-label promotion and the state of the literature from sponsors.
JAMA 2008 Apr 23; 299:(16):1949-51
http://jama.ama-assn.org/cgi/content/full/299/16/1949
Abstract:
Although the US Food and Drug Administration (FDA) reviews and approves drugs for specific indications, the approval does not usually limit the use of those drugs in clinical practice. Indeed, prescribing for indications not reviewed by the FDA (“off-label”) is common. In a recent study of 160 frequently prescribed drugs,1 off-label use represented 21% of drug mentions, and 73% of these off-label uses had little or no scientific support. Off-label use has long been controversial because large numbers of patients may receive drugs that have had only limited testing for efficacy and safety, and some off-label uses may eventually be shown to have an unfavorable risk-benefit profile. High-profile examples include the use of the combination of fenfluramine and phentermine by millions of persons for weight loss and the widespread use of hormone therapy by postmenopausal women to prevent coronary artery disease.
Although the FDA does not restrict physician prescribing for off-label indications, it does regulate the manufacturer’s promotion for such use…
Recently, the FDA proposed new guidelines that enable sponsors to distribute publications about unapproved uses of approved drugs and devices…
Selective Publication of Studies
Manipulation of the Literature
Absence of Critical Information
Potential for Undermining the NDA Review Process
Conclusions
Keywords:
Publication Types:
Research Support, N.I.H., Extramural
MeSH Terms:
Drug Approval*
Drug Industry*
Drug Labeling
Guidelines as Topic
Legislation, Drug*
Publishing*
United States
United States Food and Drug Administration*
Grant Support:
HL080295/HL/United States NHLBI
HL085251/HL/United States NHLBI
HL087652/HL/United States NHLBI
HL74745/HL/United States NHLBI
