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by Mark S. Senak
EyeOnFDA.com



Two articles from this weekend demonstrate the problems that the FDA is having with respect to its image, and confirm that one of the biggest issues is an obstinate refusal to acknowledge that there even are problems.

An interview in the New Jersey Star Ledger with Dr. Andrew C. von Eschenbach is shows the disconnect the FDA has between its actions and its words. And for those harboring hope that the new leadership would set to work on improving things - well, this is reason to reconsider.

The interviewer asked Dr. von Eschenbach whether or not the criticism of the FDA over the past few years has been justified. His response: "There is reality and then there's perception. Sometimes in this town those two things get confused. The point is, it doesn't matter. For me, if it is a perception, it is important....I want an agency in which people bring different points of view, divergent perspectives...At the end of the day, you make a decision."

Reality and perception aren't the only things confused. What the heck does that mean? Does it mean anything? Then he goes on.

"When people have concerns how that decision was made, they must have an opportunity to have that addressed. I think if we create that with the open transparency it deserves, and create it with integrity and commitment that is real, then that will be something that will change the perception as well as the atmosphere."

Ok, here was an opportunity to lay out a vision for restoring credibility in the agency. Crisis control - acknowledge the problem and let people know what you are going to do about it. This was a missed opportunity. This is on the heels of an interview with the New York Times a few weeks ago that was, as I termed then, lackluster.

But then also on Sunday, the Washington Post reported on the FDA's imminent approval of cefquinome, an antibiotic for cattle. The title of the article was "FDA Rules Override Warnings About Drug" and it reports that the FDA is about to approve a drug to which several highly credible parties have lodged objections, including its own advisory committee which met, considered the drug and voted against approval.

I don't know anything about the drug but I do know about communications and process.

Perception - reality? Transparency? When the FDA acts against the advice of its own advisors, there should be a good reason, and it needs to be clearly communicated. Dr. von Eschenbach's arcane perception, reality thing in the Star Ledger does not match to the coverage of an FDA decision in the Washington Post.

So some advice: As in prior postings, the FDA does need to get its act together about communication respecting image. Denying there is a problem simply does not do the job. And then, with respect to interviews:

First, the FDA needs to put together some messaging to answer various types of questions. Dr. von Eschenbach's rambling isn't doing anyone any favors.
Second, someone needs to media train him. He is not using the interview opportunity to enunciate a vision or to any other agency advantage. He is not bridging questions he is asked back to a set of primary core messages.
Third, when he does speak, he needs to make sure that his statements line up with agency actions to build credibility.

The agency is not only sorely in need of a good communications plan to help restore its image, but also of having it well-executed. That goal will not be achieved by telling people what you want them to believe, but by a clear effort to get to the root of the problems and fix them.


Source: EyeOnFDA.com



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