Monthly Archives: June 2006


Sorry everyone, am dealing with the rains here in DC.  Will be in full force next week! Share this:

Posted in Miscellaney | Comments Off

Everyone Piles Up on FDA for the Election Cycle

I’ve been on the road traveling for several days and lots has been happening.  The occasion of the 100th anniversary of the FDA’s existence has sparked a great deal of commentary.  Gang up!  Remarkably, all on the same day, Public … Continue reading

Posted in Crisis Communications, Current Affairs, FDA Image | Comments Off

The Supremes and Generics

You have to admire Washington.  It is the only city in the United States where, when you don’t do anything, you make news.  At least if your name is Supreme Court. Monday the Associated Press noted that the Supremes have … Continue reading

Posted in Generic Drugs, Pricing and Value | Comments Off

A Rule of Thumb – Some Tips for Pre-Approval Communications Around Data Milestones

When an investigational product is working its way down the clinical trial path, it is natural for a drug sponsor to want to communicate about its progress.  But when it comes to pre-approval communications, there are some caveats, particularly respecting … Continue reading

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Generics and Pricing, Part II – A Drug, A Price and a Senator

Recently Merck announced a lowering of the price of Zocor (simvastatin) in a move that presumably will put their brand name drug in a competitive position vis a vis an upcoming generic product, just approved by the FDA.  This brought … Continue reading

Posted in Marketing, Pricing and Value | 1 Comment