Lessons for a New Regulatory Era

J0341629 Over the course of the next several days, I’m going to be writing on the many ways in which the new regulatory era is going to affect business as usual for bringing new products to market.

Lesson 1 – The traditional approach of companies to advisory committee meetings is one that is primarily guided by the regulatory folks who work for the sponsor. The advisory committee meeting and vote for approval symbolizes the hand off of the baton to the marketing and public affairs folks.

That is an old model in a new era. (See posting of February 15)

There is every reason for regulatory to be jointly collaborating with public affairs in a very strategic way long before an advisory committee meeting. Consider this. The scientists who have worked developing a product tend to view the meeting as an exchange of scientific information. It is. But make no mistake, it is also an adversarial proceeding. There is a judge. There is a jury. There is a prosecution – and there is a defense, which is you. And just like any good trial, the media are covering it and the public are watching. A sponsor needs to be building its best case, not merely downloading data.

In the minds of the public, the vote of the advisory committee is approval or not. It is the place where the branding for the product takes its first public breath. That is why the approach should be collaborative between regulatory and public affairs, so that the messaging continuity and best case are well developed. A company wouldn’t have public affairs investigate a drug. Why would you have scientists and regulatory folks responsible for communicating about it in this most important public forum?

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