Category Archives: Crisis Communications

Anatomy of a Consent Decree

Following yesterday’s posting about catching up, another thing that happened last week is that a Consent Decree was issued by the FDA.  The company involved was Shelhigh, Inc., which produces implantable devices. First of all, what is a Consent Decree?  … Continue reading

Posted in Crisis Communications, Current Affairs, Regulatory Communications | 3 Comments

More on Melamine

Last week on the first of the month, I wrote about Melamine Creep – the idea that the discovery of a foreign substance in our pet food has made its way into the feed of pigs and chickens.  Now we … Continue reading

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What is the FDA Vision? Communications During Crisis

"Simply put, our food safety system in this country is broken," Dr. David Kessler, quoted in the Los Angeles Times, told the House Oversight and Government Reform Committee. "The fact is that food safety has been a second-tier priority within … Continue reading

Posted in Crisis Communications, FDA Image, Food | 1 Comment

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

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The Unexpected Adverse Event of Ketek – A Headache for the FDA

Last night, ABC News carried a segment devoted to the swirling controversy around Ketek, the antibiotic manufactured by Sanofi-Aventis.  The news hook was a march down from Capitol Hill to the steps of Health and Human Services by Senator Charles … Continue reading

Posted in Crisis Communications, FDA Image, FDA Policy, Pharma Industry Image | 1 Comment