DSM-5 Creates New Off-Label Prescription Opportunities


The Wall Street Journal’s Marketwatch reports that the 15 new mental disorders in the fifth edition of the DSM create new opportunities for off-label prescribing of medications.  Though pharmaceutical companies are prohibited from marketing drugs for purposes that have not been approved by the FDA, the article notes, “the DSM-5’s legitimization and expansion of certain disorders will pave the way for companies to develop and sell more drugs to treat them, and increase FDA support for new medications.”

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Drug companies look to profit from DSM-5: Binge eating and hoarding diagnoses may lead to new sales (Wall Street Journal MarketWatch)

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Kermit Cole
Kermit Cole, MFT, founding editor of Mad in America, works in Santa Fe, New Mexico as a couples and family therapist. Inspired by Open Dialogue, he works as part of a team and consults with couples and families that have members identified as patients. His work in residential treatment — largely with severely traumatized and/or "psychotic" clients — led to an appreciation of the power and beauty of systemic philosophy and practice, as the alternative to the prevailing focus on individual pathology. A former film-maker, he has undergraduate and master's degrees in psychology from Harvard University, as well as an MFT degree from the Council for Relationships in Philadelphia. He is a doctoral candidate with the Taos Institute and the Free University of Brussels. You can reach him at [email protected].


  1. Thanks for posting. This is just one piece confirming what many at MIA were saying months and months ago. This was an inevitable result of the DSM 5 and, sadly, it’s only the beginning.

    I’m curious to read from our international friends, is off-label prescribing legal in your countries? Do physicians get this dangerous latitude in prescribing medications for conditions that the medication has not been approved for?


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  2. “…from our international friends, is off-label prescribing legal in your countries?”
    In Australia, the sad answer is DEFINITELY YES (in fact most psychotropic prescribing is “off label”) And Pharma Reps do NOT have the legal limitations on pushing these as in the US. KOL’s are recruited to “push the envelope” as there. In Australia the Gov’t reimbursement scheme (Authority) specifies “diagnoses” AND doctors routinely defraud this in “prescribing off label” while noting certain non-existent diagnoses. AND rubberiness of DSM (even more as we’re seeing in DSM V) allows pretty much everyone to fit most remunerative (pharma wise) diagnoses anyway. Never challenged legally. I’ve not seen a single case for falsely using Authority diagnoses. Sorry, long way of saying yes. I expect this is true for all Anglo countries.

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  3. “… increase FDA support for new medications.”

    Actually, it’s worse than that.
    It’s rare that a drug maker creates a ‘new’ drug.
    The vast majority are re-treads… slightly modified versions of older drugs… re-packaged and sold as ‘new’ drugs, and in the case of psychiatry, for ‘new’ disorders.

    Marcia Angell, M.D. is great in this video. She gets to the ‘truth’ behind drug companies. –



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