Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

Advertising unapproved uses of drugs is free speech, which is what the FDA has been trying to say


Off-label drug use is very common.

This is a ruling a ruling that only affects New York, Connecticut, and Vermont,[1] but may be reviewed by the full Second Circuit Court and by the Supreme Court. That won’t stop it from having an effect nationally. What power does the FDA (Food and Drug Administration) have to regulate what drug representatives may say about uses of drugs that are not FDA approved uses, but are completely legal uses for the doctors they are talking to?

The FDA rules do prohibit drug representatives from discussing uses of drugs that are not FDA approved.

The FDA rules do not doctors from prescribing drugs for uses that are not FDA approved.

This is off-label drug use.

The NAEMSP (National Association of EMS Physicians) has a position paper on off-label drug use.

If EMS medical directors use a product for an indication not in the approved or cleared labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain awareness of the product’s use and effects[2]


This should be true for any medical treatment.

The most important part of the article on the ruling is this quote –

Gerald Masoudi, a former chief counsel of the F.D.A., said the ruling made a distinction between truthful discussion of off-label uses of drugs, many of which are considered legitimate by the medical community, and those that are misleading or false. He noted that “anyone on the planet” could discuss off-label uses of drugs, except for pharmaceutical companies.

“It’s very significant,” he said, “because it’s going to make F.D.A., in its promotion cases, focus on the kinds of speech that are more likely to harm consumers, such as false or misleading marketing versus something that is not approved.”[3]


Will that be the case?

That is the way it should work, but the politics of regulation may not be ready for such a reasonable approach.

The FDA should focus on whether the communication is honest and complete, rather than whether taboo topics are mentioned.


Then there are the several different flavors of off-label.

1. The label does not mention the particular use, or dose, or population as being approved. Intranasal and intraosseous medication administration are just some of the reasons that EMS drug use can be off-label drug use.

2. The label mentions the use, but points out problems with the use. Haloperidol given intravenously, or in larger doses, is an example.[4]

3. The label has a black box warning. Droperidol is an example.[5]

There are FDA approved drugs that have the same problems, but without the formal warnings. According to the small print of the FDA label, amiodarone has greater problems with QT prolongation and torsades than haloperidol or droperidol, but there is no warning.[6]

While amiodarone does not have any of these warnings, the documented rates of QT prolongation and torsades appear to be greater with amiodarone than with droperidol. Droperidol receives the kiss of death, while amiodarone receives recommendations from the AHA (American Heart Association).[7]

In what way does such an inconsistent approach benefit patients?

Off-label use has also led to many problems, but that is more than can be covered today.

Image credit.[8]

This decision has not yet been covered on The Volokh Conspiracy, which can be expected to provide excellent insight to the way the law works and what decisions mean for everyone else.


[1] United States Court of Appeals

[2] Off-Label Use of Medical Products
NAEMSP Position Statement
Position Statement in PDF format at NAEMSP.org

[3] Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses
By Katie Thomas
Published: December 3, 2012
NY Times

[4] Information for Healthcare Professionals: Haloperidol (marketed as Haldol, Haldol Decanoate and Haldol Lactate)
Postmarket Drug Safety Information for Patients and Providers
Page Last Updated: 09/29/2009
FDA letter

There is a black box warning for haloperidol, but there is no mention of this in the black box warning. This is mentioned elsewhere in all capital letters.

FDA ALERT [9/2007]: This Alert highlights revisions to the labeling for haloperidol (marketed as Haldol, Haldol Decanoate and Haldol Lactate). The updated labeling includes WARNINGS stating that Torsades de Pointes and QT prolongation have been observed in patients receiving haloperidol, especially when the drug is administered intravenously or in higher doses than recommended. Haloperidol is not approved for intravenous use.

[5] DROPERIDOL injection, solution
[Hospira, Inc.]

FDA label

Here is the first paragraph of the black box warning on the label.

Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving droperidol at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.

[6] AMIODARONE HYDROCHLORIDE injection, solution
[Hospira, Inc.]

FDA label

[7] Where are the Black Box Warnings on These Drugs – II
Rogue Medic
Sun, 11 Dec 2011

[8] Boost for Off-Label Drug Use – FDA Would Let Firms Keep Doctors Informed On Unapproved Methods
By Anna Wilde Mathews and Avery Johnson
Wall Street Journal



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