FDA Commissioner Starts Column

Yesterday you were able to hear from a former FDA Commissioner Dr. David Kessler.

Today, you can hear from the current commissioner.  On the FDA Web site, a new element has been added called "Andy's Take" and it is a weekly column from the commissioner who wants "to give you my take on some of the events about food and medical products that you have been hearing about in the news."  There is also an audio version for those interested. 

This is not a bad idea, but it would have been nice at the beginning of his tenure, not near the end.  The success of this effort will hinge not only on what he has to say, which if you look at the collection of speeches on the Web site of the FDA has been precious little, but how he says it.  He needs to be aware that the agency has lost credibility.  His number one job here needs to be to acknowledge that and work to restore it. 

In the sidebar of the column, there is this:

Through this communications column on the FDA Web site, Commissioner of Food and Drugs Andrew von Eschenbach will discuss weekly FDA issues of interest to the American consumer and occasionally preview upcoming FDA issues and events. (emphasis my own)

It had better be more than occasionally.  It should be frequently.  And it should not be about events, it should be about the issues of the day - how is FDA handling the umpteen investigations and letters from Capitol Hill?  What are the effects of the current risk-averse mindset?  What is the strategic plan for covering foreign inspections in a globalized economy?  What happened to the Critical Path Initiative?  What happened to enforcement at the agency?  Why are more PDUFA dollars going in and less product coming out?  Why has there been an increase in approvable letters?  What was his thinking in re-appointing Janet Woodcock to head CDER?

If the Commissioner is serious about making this column into an effective communications platform, he is going to have to address the issues that people are truly concerned about.  And that would be an important step for the agency. 

Comments

[Kerry Donahue]

Hey Andy

How come you won't answer questions about Provenge. Your new blog should allow questions.

Saturday is the one year anniversary of the Provenge AC vote in favor of Provenge approval. A vote the FDA ignored because Dr. Pazdur really runs the FDA.

Happy Anniversary Andy!

[Kerry Donahue]

I heard Andy got some anniversary flowers on Saturday from a friend and was worried about the saftey of the flowers so he passed them on to a nursing home.

link for physician call for FDA responsibility...please read and sign
http://www.petitiononline.com/provenge/petition-sign.html