U.S. physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: Results of a national survey

Donna T. Chen, Matthew K. Wynia, Rachael M. Moloney, G. Caleb Alexander

Research output: Contribution to journalArticlepeer-review

80 Scopus citations


Purpose: The Food and Drug Administration (FDA) regulates prescription drug marketing, not prescribing. However, off-label use is common, often lacks supporting evidence, and may expose patients to unwarranted risk.We sought to determine physicians' knowledge of the FDA-approved indications of commonly prescribed drugs, and to assess whether physicians' belief that an indication is FDA-approved increases with level of evidence supporting such use. Methods: We conducted a national random sample mail survey of 599 primary care physicians and 600 psychiatrists from November 2007 to August 2008. Physicians were presented with 14 drug-indication pairs (e.g., gabapentin [Neurontin1] for diabetic neuropathy) that varied in their FDA-approval status and levels of supporting evidence. Results: The adjusted response rate was 47%, respondents were similar to non-respondents, and physicians commonly prescribed the drugs examined. The average respondent accurately identified the FDA-approval status of just over half of the drug-indication pairs queried (mean 55%; median 57%). Accuracy increased modestly (mean 60%, median 63%) when limited to drugs the respondent reported having prescribed during the previous 12 months. There was a strong association between physicians' belief that an indication was FDA-approved and greater evidence supporting efficacy for that use (Spearman's r 0.74, p < 0.001). However, 41% of physicians believed at least one drug-indication pair with uncertain or no supporting evidence (e.g., quetiapine [Seroquel1] for dementia with agitation) was FDA approved. Conclusions: These findings highlight a pressing need for more effective methods to inform physicians about the evidence base, or lack thereof, for drugs they prescribe off label.

Original languageEnglish (US)
Pages (from-to)1094-1100
Number of pages7
JournalPharmacoepidemiology and Drug Safety
Issue number11
StatePublished - 2009
Externally publishedYes


  • Drug regulation
  • FDA approval
  • FDA label
  • Off-label prescribing
  • Physician knowledge

ASJC Scopus subject areas

  • Epidemiology
  • Pharmacology (medical)


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