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      Authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; issues and crisis management. Frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!

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    • Eye on FDA is published by Mark Senak of Fleishman-Hillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of Fleishman-Hillard or its clients.

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    June 07, 2006

    Dear FDA - A Crisis Communications Plan

    J0182826_1 When I am counseling a client on crisis communications, the first rule of such an effort is overlooked.  The first rule is DO SOMETHING.  It can be overlooked, because in seeking help, a client already knows that they have to do something.  The FDA, by all appearances, doesn't seem to get that. 

    As has been well established, the agency is in crisis.  Looking only to the last Wall Street Journal/Harris Interactive poll, within the last two years, the public confidence in the agency has slid and even inverted. 

    But there are things to do in crisis communications that, while not making the underlying problem go away, at least mitigate the probability that you become a total victim.  This basic tenet has been ignored. 

    Here, then, is some very basic and very free advice for this agency - an agency I have to say I like a lot and for which I have a great deal of respect. 

    1. 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!
    2. 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.
    3. 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.
    4. Train credible spokespeople.  There is no one who is the voice of the FDA.  Get one.  Find it.  Use it. 
    5. 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.
    6. 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.
    7. 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. 
    8. 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.
    9. 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.

    Fight back.

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    Comments

    You're making an assumption: the FDA appreciates that it has a problem. All the available data suggest the FDA is quite content with the status quo. Consider how Plan B was handled, as evidenced in the recent depositions. Doesn't sound to me like FDA thinks there's a problem. Then again, the Nixon White House didn't think it had much of a problem during most of Watergate. Oops, wouldn't want to compare those two too closely.

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