Considerations on Off-Label Issues at Prelaunch


Prelaunch is a critical time for MSLs to work with brand teams and build key opinion leader relationships for future interactions once an indication is approved. Quite often business executives thinking that MSLs have complete regulatory freedom to “promote” off-label may expect them to start proactively disseminating the upcoming opportunities to use the product. It may happen that MSLs might even get instructions from Business to use published articles with successful clinical data or product summaries from other countries where the product has been registered already in order to confirm efficacy or safety of a non-registered indication. This is the way business may see “market preparation”. MSLs are commonly coached to be good partners for sales teams and when measuring MSL performance managers often utilize an internal partner feedback survey. This may produce a risk for MSLs to turn «order takers» for Sales and eventually «off-label reps». The initial reason is that many managers believe that FDA regulations somehow grant MSLs special rights to proactively disseminate off-label information.

1. The rule is simple – nobody can promote off-label – not Sales, MSLs, Clinical Trial Managers, R&D directors, nor physicians who speak on behalf of pharmaceutical companies.

2. Any discussion initiated by company employees about off-label use including pure scientific data or published clinical cases is illegal. In case you only mentioning the non-registered indication without application to your product, anyway a compliance organization may ask you why you are doing this if you have no intention to sell.

3. Only if an off label discussion is initiated by a physician’s query (an unsolicited request) Medical Affairs people may communicate off-label data in the frames of the request. And of course the query must be truly initiated by a physician.

4. A situation when an MSL leads a professional to a discussion when she/he will eventually ask about off label uses is not a directly initiated discussion, but is a solicitation that is prohibited. Besides trying to promote your product in non-registered indications will never bring success to the team in current global regulatory environment.

So if not proactively disseminating off-label data, then what is the role of MSL at Prelaunch phase? – Business may ask. The mission of MSLs at laucnh is building relationships with thought leaders and listening carefully to physician needs for a particular disease area, learning where current treatments are insufficient and what physicians would like to see in a new product. This input becomes extremely valuable later as the company creates product messages and the scientific platform for publications. Therefore an important piece of job to be done by Medical Affairs is building clear perception of MSL role within internal stakeholders with special focus on off-label communication rules.

Written by Dr. Alexander Tolmachev

Originally published on MSL Society blog.

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