Policy ForumHEALTH CARE POLICY

Reforming Off-Label Promotion to Enhance Orphan Disease Treatment

Science  15 Jan 2010:
Vol. 327, Issue 5963, pp. 273-274
DOI: 10.1126/science.1181567

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Summary

Once the U.S. Food and Drug Administration (FDA) approves uses for new drugs, physicians are free to prescribe them for any clinical condition they see fit (1). Promotion (by manufacturers) and patient use (guided by clinicians) for any indication, population, dosage, administration, or treatment duration other than that approved by a country's regulatory authority is deemed “off-label” (2). Such use is highly prevalent; 21% of all prescription drug use, and up to 83% for certain diseases and drugs, are off-label (3).