Off-label marketing


Flask Data provides a one-stop cloud subscription for EDC, data management and statistics.

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.

Related Posts Plugin for WordPress, Blogger...

Flask Data is a technology company with a strong people focus. We are a diverse group of computer scientists and clinical operations specialists based in Israel, the US and India. We are accomplished at providing our customers with the most effective way to achieve high quality clinical data and assure patient safety. There is no single solution that works for every clinical trial. We work hard to understand your unique situation. We work with your team to develop the best solution to achieve high quality clinical data and assure patient safety the same day you engage with patients.

Flask Data – same data data and safety solutions for clinical trials.

Contact us to learn more

Tell your friends and colleagues about us. Thanks!
Share this
,