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Medical Innovation Exchange

In the face of a crisis situation, it is a given that the clarity and thoroughness of the communications response is key to resolving the issue and mitigating any reputational damage.

Perhaps no other decision by the Food and Drug Administration has garnered as much controversy, as the recent one to authorize the accelerated approval a new treatment for Alzheimer’s. Media reporting has been wide and deep on the issue. One of the most insightful was a recent article published in The New York Times that goes into extensive review of the decision and the fallout from it. The scope of the story and the revelations underlying indicate that FDA is experiencing a crisis. The agency’s response so far does not.

Just to recap the outcome of the decision – three members of the FDA Advisory committee that reviewed the application and provided an overwhelming recommendation against approval resigned in protest making it clear that they did not feel the agency valued the role of the committee’s deliberations; at least two congressional committees are investigating the approval; there may be an investigation by the Inspector General; FDA may be conducting its own internal investigation. This is an abbreviated list.

Fundamental to any crisis response is the development and delivery of a narrative that offers explanation for the events. It must be believable and clear. I, the audience, should be able to repeat it. In other words, there must be clear and digestible information that provides an explanation that is both comprehensive and credible. Lacking that sort of narrative, the story gets stitched together by the responses of others. The picture gets built from multiple sources, particularly if there are gaps in the narrative or questions which are still outstanding. Moreover, the narrative must be consistent. When the story changes, credibility erodes.

At least judging from the reporting, the FDA narrative has not always been consistent. For example, The New York Times piece points out the fact that the agency had indicated that the surrogate endpoint upon which was relied upon for the accelerated approval – the reduction of protein plaques in the brain – would not be used as a basis for approval. Then it was. That is an example of the type of thing that must be addressed in a comprehensive narrative.

Once that is devised, then the agency has the job of delivering it. That, too, requires a plan. At this point, anything said by the agency in just about any forum is going to be scrutinized and people are going to take issue with it. However, it gives one the advantage of shaping the discussion to a degree. To be reactive only allows the discussion to be shaped by others.

When providing crisis counsel, there are some key things that I always think need to be accomplished in the communications around the situation. I believe them so critical that if communications fails to address them, it raises the likelihood that the issue will continue to fester. They are:

  1. What happened? – A thorough explanation of events.
  2. Why did it happen? – What is the rationale for the series of events.
  3. What steps are you taking? – What is being done to grapple with the situation?
  4. How are stakeholders being affected? – Demonstrate a grasp regarding the points of view of both supporters and detractors and the impact of the issue on them.
  5. Who is responsible? – Who is in charge of this issue? Who was responsible in the sequence of events?
  6. What will be done to address the issue?
  7. What steps will be taken to avoid a repeat?
  8. Are you sorry?

The agency is in a tough spot. In any crisis, people have more sympathy for acts done to you (acts of nature, for example) than things you did to create the issue that is of concern. Nevertheless, these 8 things are essential to answer.

I have no inside knowledge what kind of communications planning is going on within the agency. Sound communications planning may already be underway. One hopes so. There is more than the reputation of the agency at stake, though that in and of itself is extremely important for obvious reasons during this time.

But there are additional considerations. The accelerated approval program which was conceived as a means of getting patients access to promising drugs earlier in the review process and was a direct result of both the needs presented by an out of control AIDS epidemic. It works by giving a treatment a green light based on a surrogate endpoint with the proviso that confirmatory clinical trials bear out the approval, but opening up access for patients. With its beginnings in virology, the accelerated approval program has been used extensively in oncology. The controversy surrounding this approval gives the program a black eye.

Moreover, with many withholding their decision to vaccinate for COVID-19 pending an FDA decision on the vaccines for approval beyond emergency use authorization, credibility is really important now more than ever. For these reasons, if no other, FDA should be doing all it can not only to address the controversy but to be taking a proactive approach to addressing the crisis at hand. That begins with a solid narrative.

Photo by Hello I’m Nik on Unsplash

Eric Oberwise

http://eyeonfda.com/2021/07/crisis-communications-and-fda/

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