One Consequence of FDA Senate Hearings

There was lots of news of appointments at the FDA yesterday.  In addition to the fact that Dr. Andrew C. von Eschenbach was formally nominated as Commissioner, David W. Boyer was appointed by Dr. von Eschenbach as the new head of the FDA Office of Legislation.  He will have his hands full.

Part of his job will, of course, be working on matters related to legislation.  There are some in the Senate who are quite hot to launch into FDA reform (see the column to the right).  But another part of his responsibility will be to draft Congressional testimony.

That will, among other things, include an explanation to Senators Murray and Clinton, as to why Plan B action has not been taken, despite the fact that the last candidate, who was also an acting commissioner, promised during his confirmation process that action would be taken soon.  The only action taken soon was his subsequent resignation. 

J0385346Plan B may dominate news during Dr. von Eschenbach’s Senate meetings.  However, I always want to emphasize that adverse event reporting and Phase IV commitments are also going to be topics of conversation.  Corporate communications of individual companies need to be prepared with messages regarding their methodologies and track records in these areas.  In addition, industry associations need to be prepared with messages about the track record of the industry as a whole.  To not be so prepared invites an opportunity for a public relations black eye. 

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