Off Label Drug Promotion…Coming Soon?

December 12th, 2012 by Warren S. Joseph DPM FIDSA
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(I want to thank my friend and colleague Jeff Karr, DPM (www.osteomyelitiscenter.com) for alerting me to this news story.)

Just this past week the U.S. Second Circuit Court of Appeals ruled to prohibit criminal prosecution for truthful off label promotion of drugs as a First Amendment right. An excellent analysis of the case can by the law firm of Morgan, Lewis and Bockius can be found at:  http://www.morganlewis.com/pubs/WhiteCollar_LF_CriminalProsecutionTruthfulOff-LabelPromotion_6dec12.pdf and 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 (LEIs). 

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 used for narcolepsy, which 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 that I don’t believe that 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 multi- BILLION 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 LEIs?  Currently we only have 3 antibiotics FDA approved for the treatment of Diabetic Foot Infection; ertapenem, linezolid and piperacillin/tazobactam.  This may not change in the near future.  Under the current “Acute Bacterial Skin and Skin Structure Infection” (aBSSSI) guidance being followed by the FDA for new antibiotic approval, diabetic foot infection has been SPECIFICALLY EXCLUDED.  Although I am hoping that will change in the near future, without a pathway for approval, I don’t see any antibiotics being tested for this until there is a change in policy at the Agency.  A similar situation exists with osteomyelitis.  Because the FDA does not currently have Guidance for Industry on performing a clinical trial for osteo, 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 DFI and osteo that have not been promoted for lack of indication.  If this current ruling stands I don’t see why a rep couldn’t 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 physician would be getting sound information to which they may not have been aware and the patient would receive evidenced based therapies which may currently be withheld from them over fears of unlabeled use.  To me, this is a no-brainer.  Thoughts?  Comments?

Posted in Antibiotics, Diabetic Foot, Infections, Osteomyelitis

2 Responses

  1. drkarr

    I am hopeful this initial ruling will expand to have a deep and meaningful impact as there is a lot potential in this initial ruling to allow industry to start to disseminate important off-label information to help our patients.

    Most of this information already resides in the public domain by virtue of being perviously published or presented and should be allowed to re-distributed by a rep as long as the information is factual and not being misrepresented by the rep.

    Furthermore, physicians and other medical professionals that have collected meaningful data, patient case series data, or other research should be able to also be able to lecture and share their “off-label” findings and success at an industry sponsored function without fear of criminal repercussions.

    As Dr. Joseph very keenly pointed out osteomyelits treatment is for the most part is off label, except for HBOT treatment for chronic, refractory osteomyelitis. Personally it is very frustrating not to be able to partner with industry, because of the off-label brand, to “get the word out” about advances in treatment and pharmacological success we have at the The Osteomyelitis Center in treating osteomyelitis.

    To me, it would nice to have these shackles lifted to disseminate information to help our patients.

  2. drkarr

    Warren,

    I am really surprised this received no press, any thoughts?

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