Remember the Cat in the Hat? The book, not the movie. It is a story about some children who make a small mess of things. The cat in the hat comes along, and through some inept clean up, the mess grows, and grows and grows.
I was reminded of the book when I saw that the House Energy and Commerce Committee is seeking to interview all of the FDA staff who were connected with the preparation of Dr. Andrew C. von Eschenbach’s testimony before the committee on March 22. That testimony centered on drug safety, but went into a great deal of detail about Ketek.
There is nothing good in this for the FDA. What began as in inquiry into the approval of a drug has now grown into a debate about the veracity of the FDA.
But I am not going to address the issue of Ketek itself, I’m more interested in the issue of good issues management – a concept that seems to escape many in government who become the subject of scrutiny and in this cast – the FDA.
When an issue presents itself, it does not do to deal with the symptom, you have to deal with the whole matter. It requires a careful analysis of the issue – who are the stakeholders, what are their motives, who are their allies? Create a playbook that considers scenarios and what you need to meet them head on. Where are your allies? Who can carry water? What assets do you have to arrest the issue or minimize the damage? Then do the math and make sure your spokespeople are well-trained to the task at hand. That is good issues management.
But when you try to address the issue,
inch by inch,
spot by spot,
why then it is a problem you got.
Hey,
I am wondering about what people are saying about the clincal trial and approval processes and their relation to innovation in pharmaceuticals.
I have seen people talk about lowering costs and finding more predictive methods, so not as much money is sunk on failures. I have also heard about approving when just showing that it works better than a placebo, and not different or better than another drug in the field.
Do people talk about how CRO’s or other parts of the trials or approval processes affect innovation? I would love any guidance, thanks!