Off-Label Drug Promotion: Coming Soon?

Warren S. Joseph DPM FIDSA

The U.S. Second Circuit Court of Appeals recently ruled to prohibit criminal prosecution for truthful off-label promotion of drugs as a First Amendment right. An excellent analysis of the case by the law firm of Morgan, Lewis and Bockius is available at: . I direct anyone interested to read this summary. I will not go into details but rather discuss how this may affect antibiotics and lower extremity infections.

The case, United States v. Caronia, was against a drug rep who was taped on two occasions discussing off-label use of a drug, Xyrem (Jazz Pharmaceuticals), used for narcolepsy. Conspiracy to introduce a misbranded drug into interstate commerce is a misdemeanor. From my interpretation of the referenced information, it appears that the court decided that since the Food, Drug and Cosmetic Act allows physicians to legally prescribe any licensed drug for any indication, promotion of such use, as long as it was not false or misleading, was a “lawful activity” protected by the First Amendment.

I will start by saying I do not believe this will open the floodgates for armies of drug reps knocking down doors to speak about unapproved uses. This will probably have to go higher in the court system with the next step being the Supreme Court. Furthermore, many of the Big Pharma players are running somewhat scared of the Feds right now having sustained multibillion-dollar fines and signing “corporate integrity agreements” with the government that puts very strict rules in place on what they can and cannot do in terms of promotion.

How does this impact antibiotics and lower extremity infections? Currently, we only have three antibiotics that are approved by the Food and Drug Administration (FDA) for the treatment of diabetic foot infection: ertapenem (Invanz, Merck), linezolid (Zyvox, Pfizer) and piperacillin/tazobactam (Zosyn, Pfizer). This may not change in the near future. The current “acute bacterial skin and skin structure infection” (aBSSSI) guidance that the FDA follows for new antibiotic approval specifically excludes diabetic foot infection. Although I am hoping that will change in the near future, without a pathway for approval, I do not see any antibiotics being tested for this until there is a change in policy at the FDA.

A similar situation exists with osteomyelitis. Since the FDA does not currently have guidance for industry on performing a clinical trial for osteomyelitis, no antibiotic has been approved for the indication in close to 20 years. In the meantime, there have been a number of excellent antibiotics with good clinical data for both diabetic foot infections and osteomyelitis that have not been promoted for lack of indication.

If this current ruling stands, I do not see why a rep could not speak to a doc in a truthful and scientific manner, using published literature, to discuss the possible off-label use of a given drug. I really feel that all would benefit. The physicians would be getting sound information to which they may not have been aware and the patient would receive evidenced-based therapies that may currently be withheld from them over fears of unlabeled use.

To me, this is a no-brainer. Thoughts? Comments?

I want to thank my friend and colleague Jeff Karr, DPM ( ) for alerting me to this news story.

Editor’s note: This blog was originally published at and has been adapted with permission from Warren Joseph, DPM, FIDSA, and Data Trace Publishing Company. For more information about the Handbook of Lower Extremity Infections, visit

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