Related to yesterday’s posting, one of the consequences of the "new environment" of the post-COX-2s is that, because issues involving drug approval are getting more attention from both the public in general and policy makers in particular, the communications issues associated with drug approval have proliferated.
Under the "old" model, the regulatory department of a drug sponsor was primarily tasked with preparing the company’s case before the FDA, because of course, it is a regulatory filing. Well, it was.
Today, however, it is also a public affairs program demanding a communications assessment and involvement that regulatory departments simply aren’t equipped for. In other words, the old days of handing off the baton to marketing at the time of approval, may be over – or at least should be.
Yesterday I spoke of the need to have the pivotal Phase III trials evaluated through a lens of the post-COX-2 lessons. The task does not stop there. Once assessed, there should be a master issues map developed. That issues map becomes the Bible for building a best case for approval. It also becomes the basis for the development of marketing Q&A because the case made at the time of the FDA Advisory Committee will now be the same case made to consumers and prescribers. Or, as I often like to say, and have said here before, an Advisory Committee is where branding for the product takes its first breath.
That means, that prior to any advisory committee meeting a company not only knows where all of its warts are, but has developed a communications strategy that either directly or indirectly deals with some of them. If done, and done well, by the time one gets to FDA approval consideration, the road may be better paved.
But that kind of planning has some prerequisites:
- the drug sponsor cannot be so siloed that its regulatory department can’t or won’t interact with public affairs;
- public affairs has to understand their mission
- the limitations need to be recognized as well as the benefits
- timing is everything – you cannot begin a few months before your FDA consideration and expect a very big payoff.
But it is good to keep in mind, that the day after the 3-day COX-2 Advisory Committee meetings, the sun set on the old way of public relations support of new candidate products. Those operating under the old paradigm are more likely to be stuck in yesterday.