When is off-label marketing ok?

Is it ok to market a drug off-label? The answer is NO and YES.

NO — For a pharmaceutical, the answer is a definite no. For example, Elan Pharmaceuticals recently pleaded guilty to off-label marketing of its epilepsy drug Zonegran, and was sentenced to pay a criminal fine of $97 million and forfeit $3.6 million in substituted assets.

YES — However, for other people, the answer is YES.

A New York Times article, “From MS Patients, Outcry for Unproved Treatment”, tells the story of a multiple sclerosis (MS) patient, Neelima Raval, who went to the office of Dr Daniel Simon armed with “a rolling file cabinet full of documents” about a non-FDA approved treatment that is based on the premise that narrowed veins causes MS. Dr Simon “sensed that Ms. Raval would have no peace unless she could learn whether she had narrowed veins”. So to make a long story short,  Dr Simon acquiesced [my word] to the patient, found out that she had narrowed veins, and performed interventional radiology to open her veins, which Dr Simon admits is an “off-label speciality” (basically taking a device approved for one purpose and using it for another).

Although this post could be about this non-FDA approved MS treatment, I recount this story because it illustrates two interesting aspects about off-label use and marketing:

  1. What happens if the doctor, who is now convinced of the procedure’s effectiveness to treat MS, sets up a clinic. At this MS clinic, he treats patients with FDA-approved treatments. As well, for patients with narrowed veins, he performs the new “off-label” procedure.
  2. Just say the patient, who is so impressed with how the new treatment has worked for her, decides to set up a MS advocacy organization to tell other patients about it. She doesn’t offer medical advice, she only recounts her experiences and gets other patients who have had the new “off-label” procedure to do the same.

For the doctor and the patient in the scenarios above, their support for the “off-label use” comes from their “real world” experiences, not from a scientific, laboratory experiment. Both have the right to “promote” the off-label procedure — in the case of the doctor to do what is medically best in his judgement and in the case of the patient to tell her personal story.

For the manufacturer to get approval, clinical trials would need to be conducted; and from the results of those trials, the FDA would give approval for the use that was demonstrated. And, yet, I find it curious that the manufacturer can’t talk about (i.e. promote) either scenario. Do you?

2 Responses to “When is off-label marketing ok?”
  1. Michael Wong says:

    Irene Lombardo @IELhealthwriter, an award-winning writer on health and wellness issues, comments:
    “Prohibiting off-label marketing is understandable given no supportable data or suspect data. FDA should fast-track research for these uses.”

  2. honestly, if it works, it works. As long as the benefits outweigh the risks, then physicians are doing no harm and the patients are benefiting.

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