Regulating off-label drug use - Rethinking the role of the FDA

New England Journal of Medicine

Volumn 358, Issue 14, 2008, Pages 1427-1429

  Stafford, Randall S ^a  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTIBIOTIC AGENT; ANTICONVULSIVE AGENT; BEVACIZUMAB; GABAPENTIN; METFORMIN; MONTELUKAST; NEUROLEPTIC AGENT; OLANZAPINE; PAROXETINE; QUETIAPINE; RECOMBINANT ERYTHROPOIETIN; ROFECOXIB; TACROLIMUS;

AUTOIMMUNE DISEASE; CARDIOVASCULAR DISEASE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CHRONIC PAIN; CLINICAL PRACTICE; DEMENTIA; DEPRESSION; DIABETIC NEUROPATHY; DRUG EFFECT; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; HEALTH CARE POLICY; HEALTH HAZARD; HERPES ZOSTER; HUMAN; OFF LABEL DRUG USE; OVARY POLYCYSTIC DISEASE; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; RISK ASSESSMENT; SHORT SURVEY; TREATMENT FAILURE; UNSPECIFIED SIDE EFFECT;

EID: 41649086195     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp0802107     Document Type: Article

References (4)

1. Guidance for industry: good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices (draft guidelines). Rockville, MD: Food and Drug Administration, February, 2008. (Accessed March 14, 2008, at http://www.fda.gov/OHRMS/DOCKETS/98fr/ FDA-2008-D-0053-gdl.pdf.)
2. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med 2006;166:1021-6.
3. Adams C, Young A. Risky Rx: a Knight Ridder investigation. Newspaper article series, November 2-4, 2003. (Accessed March 14, 2008, at http://www.mcclatchydc.com/244/story/28122.html.)
4. Dai C, Stafford RS, Alexander GC. National trends in cyclooxygenase-2 inhibitor use since market release: non-selective diffusion of a selectively cost-effective innovation. Arch Intern Med 2005;165:171-7.