FDA Heal Thyself – A Prescription for Crisis Communications

J0386197 Last week there was an interesting exchange of opposing opinion in USA Today between the paper and Dr. Steven Galson of the FDA regarding the agency’s abilities to protect public health.  The paper cited the recent GAO report on the FDA that stated that problems within the agency were hobbling its abilities and that the agency lacked

  • clout to demand post-marketing studies
  • high turnover in key jobs
  • tension within the agency, particularly the Office of New Drugs and those responsible for safety

Dr. Galson countered under a headline "We’re Curing Ourselves".  As evidence of the agency’s turnaround, he cited the new prescription drug label design, enhanced safety oversight and the critical path initiative. 

Without commenting on whether or not those proofpoints actually address the problems being raised by critics, the agency should bear in mind that to recover credibility, they need to employ spokespeople who have some sure footing.  Dr. Galson has been reported in the Washington Post to have been one of those in the FDA who took an approach to the Plan B approval that was unorthodox.  His apparently significant role in that controversy does not position him well to be a spokesperson who enjoys a high level of credibility with critics.

The FDA needs to develop its message points to address the issues raised by the GAO Report – ones that actually do address point by point the concerns of critics.  But just as important, they also need to consider a basic tenet of damage control – credible spokespeople conveying the message. 

A primary principle in crisis communications is that, as an involved party, your word carries a diminished weight.  No matter who the FDA spokesperson is, if the agency speaks on its own behalf, the impact is less than what it otherwise could be.  Rather, if you are being attacked, it is to your advantage to get outside spokespeople who have significant gravitas and credibility to carry your water.

In this case, that might be a former HHS Secretary, a former CDC director, a former Surgeon General or a former FDA Commissioner (not Drs. Lester Crawford or Mark B. McClellan) to pen opinion pieces, letters to the editor and to speak on behalf of the agency.  These would be individuals who had run large agencies and can speak to the issues involved in setting a broken bureaucracy right as well as answer, and perhaps even humble critics with their experience. 

However, the use of Dr. Galson in this case provides some insight that the agency either does not understand basic principles of crisis communication or does not feel that they have the need for it. 

We should hope it is the former – for that they can and should get help. 

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