One of the many lessons available from the track record of the FDA last year involves communications and preparation for advisory committee and FDA approvals. There increasing numbers of approvable letters than there were declines in approvals last year. There has been a seismic shift in how products are approved and what factors are involved, whether or not it is official policy.
Today’s tendency is to err on the side of caution when considering new drug applications, while yesterday’s was to assure access as quickly as possible to new therapies.
The result, a spate of approvable letters which directly affects the life cycle of a product. That, in turn, as noted in my posting last week, affects the management of that product by those in the sponsoring company who are shepherding it through the approval process.
Traditionally, the companies tend to think of communications support beginning with the product’s advisory committee meeting when regulatory hands off the product to marketing. Communicating advisory committee results and planning the product launch are often the first activities of the professional communicators. That is an approach that, to say the least, is very yesterday.
Many companies view an advisory committee as an exchange of scientific information and it is, but it is also, now more than ever, an adversarial proceeding. There is a judge, jury, prosecution and defense and there are witnesses. There is also a media who are going to cover it in depth. This part of the approval process is where branding takes its first breath, as I’ve said many times, and an approvable letter has a dramatic impact on that.
The presentation team of a company has to be about more than the science, it has to be made up of highly effective communicators. And, while there is not pre-approval promotion, a communications strategy in the months leading up to an advisory committee meeting is now an essential component of an overall communications plan, not a luxury. As demonstrated this year, even if the candidate compound put forth for approval is in a much needed therapeutic category, concerns about deficits with the clinical trials or profile of the drug will not be overlooked.
In short, communications planning needs to begin much earlier in the life cycle of the product and should support the product for months prior to an advisory committee meeting. That includes an assessment of all the warts that a product has – a reading of the current environment – and a strategy for dealing with the various issues associated with a new compound aimed at targeted markets and thought leaders.
Every product has weaknesses. Without a firm communications strategy to address them, in today’s environment, it could be the difference between an approval and an approvable letter.