Justinian Lane

Free Speech, Off-label marketing, and the learned intermediary doctrine

St. Louis today has an editorial that persuasively argues that off-label marketing should remain illegal:

Off-label marketing may be against the law, but off-label prescribing is perfectly legal, even common. About one in five prescriptions written in the United States each year is for an off-label use.

The contradiction between how drugs are marketed and how they are prescribed creates a gray area that opened the door for the Allergan case.

Source: Off-label drug marketing threatens patients. It could soon be legal. -

As the article explains, when a pharmaceutical company gets FDA approval for a drug, the approval is for a specific usage.  For example, Viagra is approved for the treatment of erectile dysfunction.  Pfizer may market Viagra only to treat erectile dysfunction.  As it turns out, some doctors are using Viagra to treat primary pulmonary hypertension (PPH).  Pfizer may not market Viagra to treat PPH.  The reason why is because Pfizer has not demonstrated to the FDA that Viagra is safe and effective in treating PPH.

It’s not surprising that pharmaceuticals want to end the off-label marketing ban.  If they could push their products for the treatment of anything it would certainly increase sales.  I agree with the St. Louis Today editorial that ending the off-label marketing ban would put consumers at risk.  However, I am also sensitive to the manufacturers’ free-speech interests.  So I have a novel solution.

I would end the off-label marketing ban, but I would also end the learned intermediary doctrine.  The learned intermediary doctrine traditionally prevents consumers from suing pharmaceutical companies for failing to warn consumers of the dangers of a prescription drug.  Instead, a consumer has to sue the pharmaceutical company for failing to warn doctors of the dangers of a specific drug.  Because consumers can’t just buy a prescription drug on their own, they have to get a prescription from a doctor.  The doctor acts as an intermediary between the consumer and the pharmaceutical company.  And it is the doctor’s responsibility to ensure that the patient is a proper candidate for the drug.

I believe if we abolished the learned intermediary doctrine, pharmaceuticals would be more forthcoming in their disclosures about specific drugs.  Warning consumers about the dangers of a drug is different than warning doctors.  Pharmaceutical companies would have to do more to educate the public than release a study in a medical journal, for example.

More importantly, abolishing the learned intermediary doctrine would take into account how drugs are actually prescribed.  In reality, many patients see a drug on TV and then decide they want that drug.  They then get an appointment with their doctor, ask the doctor for a prescription, and the doctor writes the prescription with few if any questions.  Instead of acting like a “learned intermediary,” many doctors act like nothing more than a middleman, happy to collect an office visit fee in exchange for a prescription for just about any drug a patient wants.  Abolishing the learned intermediary doctrine would force pharmaceuticals to actively attempt to warn consumers about the dangers of specific drugs.  This can only improve patient safety.

I hope that the off-label marketing ban stands.  But if it falls, I suggest we reconsider the learned intermediary doctrine as well.

UPDATE: I got a very polite email from a representative of Pfizer regarding an error in the above post. From Pfizer:
"Viagra is also known by the chemical name sildenafil. Pfizer markets two formulations of sildenafil: Viagra, which is approved by the FDA to treat erectile dysfunction, and Revatio, approved for the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability and help lessen symptoms and slow down worsening changes in a patient’s physical condition. Thus, while the statement is correct in stating Viagra is not indicated for the treatment of PAH, there is a formulation of sildenafil FDA-approved for the treatment of PAH. "

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Posted at 12:38 PM, Apr 15, 2010 in Pharmaceuticals
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So what happens if the Pharmas tell the docs everything they know, and the docs don't pass it on cause they continue to be middlemen. Pharmas still get sued by customers?

Posted by: Adam | April 15, 2010 3:45 PM

Hi, Adam. If the pharmas do tell everything to the docs, the pharmas will typically win. So in cases where the pharmas have disclosed everything, injured patients usually have to sue the doctors for malpractice. Here's a hypothetical example:

The package insert for Drug X says absolutely do not prescribe to pregnant women. A doctor prescribes it to a pregnant woman, and she is injured. In this case, the pharmaceutical company warned the doctor through the warning label so any lawsuit would be against the doctor.

If the pharmaceutical company knew the drug shouldn't be prescribed to pregnant women, but didn't put it in the label, the lawsuit would be against the pharmaceutical company.

Posted by: Justinian Lane | April 15, 2010 4:21 PM