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- Title
Off-label or off-limits?
- Authors
Ratner, Mark; Gura, Trisha
- Abstract
This article discusses the seemingly contradictory regulation of advertising off-label drug use while such use remains a regular medical practice. The moral questions surrounding off-label drug use, which range from personal freedom to the medical ethics of clinical trials, are considered. The supplemental new drug application process is considered as one portion of the regulatory structure surrounding off-label use. The possibility that guidance from the U.S. Food & Drug Administration (FDA) could help to redefine what constitutes off-label drug use is considered. The regulations of the U.S. Centers for Medicare and Medicaid Services (CMS) are also presented as a complicating factor in the regulation of off-label drug use.
- Subjects
UNITED States; OFF-label use (Drugs); PHARMACOLOGY; HEALTH insurance; CENTERS for Medicare &; Medicaid Services (U.S.); UNITED States. Food &; Drug Administration; DRUGS &; economics; DRUG utilization; GOVERNMENT policy; SAFETY
- Publication
Nature Biotechnology, 2008, Vol 26, Issue 8, p867
- ISSN
1087-0156
- Publication type
Article
- DOI
10.1038/nbt0808-867