Off-label marketing

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I recently read an article by Adriane Fugh-Berman and Douglas Melnick about Off-Label Promotion, On-Target Sales

In the pharmaceutical industry, there are two ways to market an approved drug for a new use: the “indication” route—performing studies necessary for regulatory approval—or the “publication” strategy, which stimulates off-label prescribing by using research “to disseminate the information as widely as possible through the world’s medical literature” (Steinman MA, Bero LA, Chren MM, Landefeld CS (2006) Narrative review: The promotion of gabapentin: An analysis of internal industry documents. Ann Intern Med 145: 284–293.)

Pharmas want to be ethical but there are threats to ethical behavior:  the need to approve a drug quickly and grow sales by applying drugs to off-label indications. One approach for a pharma to mitigate the risk off-label marketing is to control communications to doctors using social networking tools:

Step 1 – Provide well known medical authorities with a controlled and moderated channel for blogging in a professional network for medical reps and docs The blogs would feature independent opinions, and be moderated; ensuring that the industry experts are able to provide objective information on efficacy of drugs and evidence-based prescription and help pharmas comply with FDA regulation prohibiting off-label promotion.

Step 2 – Provide practical dosage guidelines according to drug indications on a professional network for medical reps and docs A rep, product manager and pharma have a private, professional channel to communicate recommendations in a practical and ethical manner.

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