FDA Approves Off-label Use of Drugs

Karen Lee Richards Health Guide
  • Until last month, when pharmaceutical representatives visited your doctor's office, they were only allowed to tell the doctor about FDA-approved uses for their company's medications – even though approximately one fifth of all prescriptions written are for off-label use.  (Off-label means prescribing a medication for a purpose that has not yet been approved by the FDA.)  Now, under the FDA's newly approved guidelines, pharmaceutical salespeople are allowed to give your doctor articles about these off-label uses if they have been published in a peer-reviewed medical journal that requires disclosure of conflicts of interest for researchers. 

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    Critics of the new guidelines say the change could result in drug companies promoting what could be potentially dangerous medical practices.  Personally, I welcome the change.  Physicians are so busy these days, they don't have time to pour over dozens of medical journals every month searching for clinical trials of new medication uses.  If the pharmaceutical reps can provide them with articles on   studies that apply to the patient population they serve, so much the better. 

    Of course, I have a very personal reason for wanting doctors to know about other potential uses for different medications.  Until Lyrica was approved for fibromyalgia in June 2007, there were no FDA-approved medications for FM.  Many doctors were hesitant to even attempt to treat fibromyalgia  patients beause they didn't know what to do for them.  Now that there are three drugs with FDA-approval for the treatment of FM, doctors feel more comfortable treating fibromyalgia patients.  Had the pharmaeutical reps been allowed to give the doctors copies of all the studies done on these medications before, perhaps more patients could have been helped sooner. 

    There are a number of other potential FM medications that have shown promising results in clinical trials:  tramadol, pramipexole, sodium oxybate, and pindolol for example.  Since the pharmaeutical reps can now give physicians the studies on these drugs, I'm hopeful that more treatment options will be opened up for FM patients. 

    That's my opinion.  I'd like to know what you think about the new FDA guidelines. 


Published On: February 02, 2009