As a digital agency working with pharmaceutical, and other healthcare-focused, companies we deal with Medical / Regulatory / Legal (MRL) groups on a daily basis. Internally this can cause a bit of friction as some of Klick’s employees get “Stockholm Syndrome” from extended exposure to the more risk-averse groups at the client. When Klick employees exhibit an overabundance of caution, myself included, I call this “Phantom MRL.”
Causes of Phantom MRL
There are numerous causes of Phantom MRL in an agency:
Continued, close contact with client MRL
For employees who spend extended periods arguing with reticent MRL groups about whether a tactic will be tolerated by the FDA this can cause a chilling effect on internal ideas. The words “MRL will never go for that” must come up in almost every brainstorming session. As an agency that prides itself on creative digital executions for its clients, this is a poison, especially when it happens early in the design phase.
Extended, in-depth reviews of FDA guidances and notices
Sometimes it is exposure to the FDA materials themselves that can cause Phantom MRL. I know that I can suffer from this at times, even when writing Klick guidances and POVs. The idea is that the written POVs provide a conservative, considered opinion on FDA actions and guidances so that our clients can interpret them safely. When we then move forward with projects we should be looking for ways of extending the legitimate ways of communicating with customers.
Fear of repercussions of regulatory action
The final, and maybe strongest, pressure that creates Phantom MRL is the fear of instant termination if a client gets a notice of violation (NOV) from the FDA. It is considered common knowledge in the healthcare agency world that if your work nets an action from the FDA you will be on the chopping block within hours. This runs counter to the very successful “fail fast” approach that successful startups employ but it seems to be a very real phenomenon.
How to fight Phantom MRL
We have a few tactics to combat Phantom MRL:
- Forbid the criticism of ideas in the early stages of brainstorming, allow only “yes and” comments and answers
- Allow MRL-predicting only at the very end of the process
- Ensure that any ideas considered borderline are still allowed to move forward to ensure we test the boundaries
- Only invite the employees who have become infected with Phantom MRL to later meetings
- Ensure that we build solid, long-lasting relationships with all stakeholders in our clients’ organizations so that we can test ideas quickly
There are no easy answers to Phantom MRL, and a fully effective vaccine is yet to be developed, so all team members on healthcare marketing projects need to remain vigilant and look for signs in their peers so that it can be corrected before it spreads.