What Are IDEAs Made Of: The Label
Without a label, there is nothing. In the US, and many parts of the EU, for example, if it isn't in the label, you can't say it. If your differentiation isn't written in there, you have no differentiation. You can do all the Sales Effectiveness, Marketing Excellence and CRM you want, but you're just throwing good money after bad.
So, this must surely be regarded as the critical piece in Development, and pre-launch Marketing, the subject of a lot of honing and planning? Well, no… The Target Product Profile (TPP) has been the stand in for the label for so long, despite doing such a bad job of it. Like a really bad substitute teacher, the TPP has allowed all manner of behaviours under its nose without ever achieving the kinds of outputs desired.
"The Target Product Profile (TPP) has been the stand in for the label for so long, despite doing such a bad job of it."
While so many look with woe at increasing R&,D costs, and declining approvals, at least one of the things that is broken in that equation is the mismatch between what markets (and regulators) want, and what companies are doing with their molecules.
One process change that immediately makes a difference to crossfunctional teams in pII and pIII is to develop a draft label. As soon as that draft is written, everyone has just nailed their colours to the mast - Clinical suggesting that the current Clinical Development Plan will deliver what's in the label, Commercial that what is in the label gives them a chance of selling the product, Regulatory that the label is approvable. Seems so easy, and indeed it is not rocket science.
Writing the draft label forces discussions, making teams make decisions between outcomes such as non-inferiority vs superiority, about the choice of comparator, the regimen, the dose, about claims for safety, tolerability and any patient-reported outcomes or pharmacoeconomic evaluations. And those discussions are all healthy, appropriate discussions for a crossfunctional team to have.
On the other hand, the TPP, instead of providing a target, tends to reflect what teams believe the product will definitely achieve, hand on heart. The idea of a target in the Target is lost, and along with that loss, goes a whole bunch of potential decisions about whether that is any good or not. Its sheer vagueness forces vague communication into the team - "so what will we have?" "Well, we'll have whatever the study shows…" "But, doesn't that depend on what we set the study up to show..?"
"...a desirable label should be discussed and evaluated for feasibility all the way back in phase II."
Label discussions are not the preserve of the regulatory teams. No regulatory committee in history has suggested the best possible form of wording for a label - that needs to be taken in and negotiated by the submitting company. To make that possible, a desirable label should be discussed and evaluated for feasibility all the way back in phase II.
No company launches a product. They launch a label. Despite all of the attention on the former, the lack of attention given to the latter is one of the real reasons that companies are seeing declining R&,D productivity, and continue to launch unsuccessful drugs.
About the author:
Mike Rea is a Principal with IDEA Pharma, who enjoys taking a look outside the industry to learn how it can think differently. For direct enquiries he can be contacted on mike.rea@ideapharma.com and for more information on IDEA Pharma please see http://www.ideapharma.com/what/default.htm.
At what stage of development should we consider labels?
