Home Guidelines Policy Statements Use of Off-label Drugs for the Treatment of Urological Patients

The Use of Off-label Drugs for the Treatment of Urological Patients

The American Urological Association (AUA) and the Urology Care Foundation endorse the following statement regarding the use of off-label drugs for the treatment of urological patients.

"FDA has clear regulations based on legislation stating that a drug label is in no way intended to regulate or restrict the ability of practicing physicians to use the drug for other purposes consistent with their medical knowledge and professional judgment. The AUA strongly believes that if the related urological indications are listed in the major U.S. drug compendia and/or supported in peer-reviewed medical literature that payors, including Medicare, should develop fair and rational coverage policies for such usage."

Board of Directors, May 2004
Board of Directors, October 2008 (Revised)
Board of Directors, October 2013 (Reaffirmed)
Board of Directors, October 2018 (Reaffirmed)



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