On December 11, following the vote to make Dr. Andrew C. von Eschenbach the FDA Commissioner, after years of "acting" status commissioners, I wrote in a posting: "…Dr. von Eschenbach should use the opportunity of the next few months to lay out not only a vision, but communicate the means as well – and get past the ribbon cutting speeches. It is one thing to say we are going to go to the moon. It is quite another to build the apparatus that gets you there. Lofty goals have to be backed up by sound planning and good communications to restore credibility."
A few months have passed. Nothing has happened. There was the lackluster interview in the New York Times mentioned in Monday’s posting, but if you visit the listing of speeches given by FDA officials on the FDA Web site, you will find that the last speech given was on December 5, 2006 and was given by Dr. Scott Gottlieb, no longer with the agency. The FDA has had nothing to say for the past 9 weeks.
The FDA has been on the receiving end of a number of black eyes. From its own actions perceived as mistakes, to serious mis-steps such as Plan B, to external actions – public opinion polls, the Union of Concerned Scientists, the IOM Report, the GAO Report, Public Citizen charges of FDA Advisory Committee partiality – to Congressional critics in the Senate (Grassley) and the House (Waxman), there is a mountain of evidence that the FDA’s once golden image has been highly tarnished by neglect.
And so I repeat crisis advice written on this blog on June 7, 2006 for the FDA: Here is a prescription for getting out of your hole. First and foremost, stop pretending there isn’t a problem. Read the paragraph above. Then, Dr. von Eschenbach:
- Devise a Plan. There are two ways to respond to a crisis. One is to pretend you are a deer in headlights and do nothing. The other is to form a plan. The former usually makes you a victim. The latter gives you a fighting chance. Make a plan!
- Acknowledge the Problems. One of the worst things you can do in a crisis is to believe your own bullshit. The reason one is in a crisis is because people have stopped believing in what one is saying. Therefore, one has to either (i) find something different to say or (ii) find a different way of saying it. To do the same thing repeatedly and expect a different outcome is, well, the height of dysfunctionality. In this case, the FDA has to acknowledge that they need to find ways to deliver safety and that they have made mistakes – i.e., Plan B. No one believes that Plan B was not a mistake. Admit it and move on.
- Develop messaging (or ways of delivering it) that work. One of the reasons that the FDA image has slipped among consumers isn’t because of a conspiracy, but because what they were saying (or the way they were saying it) hasn’t worked. By going on delivering "business as usual" one only stares into headlights. You have to MOVE. Consider each and every one of the message points against you and develop counter-messaging. Anticipate your opponent’s point of view (POV) and develop language that convincingly counters it. To talk about the Critical Path Initiative as if people still have faith in it when they are lacking faith in it, isn’t going to do any good. To launch new initiatives when your credibility is in question, doesn’t move the needle. To not clarify the safety track record when it is being misconstrued does you no favors. To allow focus on risk when you bring so much benefit shoots yourself in the foot. Get moving. Identify messaging, test it and launch it.
- Train credible spokespeople. There is no one who is the voice of the FDA. Get one. Find it. Use it.
- Ally Development. There are a lot of people, like myself, who think highly of the agency, give them message points and use them. Get them in speaking venues, have them write op-eds, create a POV that counters that which is prevailing.
- Answer the Charges. For goodness sake, the agency was faced with a major challenge when the Wall Street Journal/Harris poll was released. Your voice was not heard. How do you feel about what was said? Also, see number 2 above. Acknowledge the problem and then state how you are going to address it. Pretending that you are not in trouble doesn’t get the job done.
- Play to Your Strengths. The Critical Path Initiative needs to be made something that people believe in. The agency is commanding a huge task and undertaking it, on the whole, very well. That never comes out. Not because it is not a fact, but because no one from the agency is talking the talk or walking the walk before audiences who can carry the agency’s water. Rather, somewhat staid speeches are delivered before somewhat safe audiences. You are an evidence-based decision making body. Get the evidence, make the decisions and talk about them in a way that is motivating.
- Deflect the Focus. While this one is more challenging, the truth is that barely a single agency in this Administration is not in crisis. Spread the focus to recognize the fact that there is a larger crisis in confidence in government, not just the FDA.
- Do Something. The agency has sat passively by while its reputation has suffered tatters in the public domain. Where are the op-eds? Where are the letters to editors? Talk and talk a lot.
Stop the inertia!