Weekly Roundup – 2/1/08

J0149000Well, 2008 is 1/12 over!  That was fast.  And the election cycle carries forward with far fewer candidates.  For the first time in history, there will either be a candidate nominated who is an African American or a woman by a major party.  The Republican field has narrowed again and Super Tuesday is… well, it is Tuesday.

To help you with sorting things out, some of my brilliant colleagues at Fleishman-Hillard have pulled together a detailed election guide which I posted not long ago.  Please note that it has been updated and includes current delegate counts, primary dates, open primaries, closed primaries and congressional schedules. 

And it was also an active, and somewhat tough week regarding the other things we care about. 

  • Labopharm Formal Dispute Resolution – Contributing to my point of view that Formal Dispute Resolution is not a successful route, Labopharm received notification from the FDA that it was not overturning its approvable decision respecting the company’s product once-daily Tramadol.  However, according to the company release, the FDA "has suggested additional statistical analysis of existing data as a means to potentially satisfy the Agency’s requirements. The statistical method proposed for the analysis is different from that previously requested by the FDA since the May 2007 Approvable Letter…"  Hang on.
  • Merck’s Mevicor Gets Thumbs Down – And speaking of rejection, in what cannot possibly be the least surprise to anyone, Merck received a non-approvable letter from the FDA for their OTC switch application for the anti-cholesterol statin Mevacor.    This application, which faced an uphill battle from the beginning, saw things get from bad to worse and the news environment on statins soured somewhat over the period of time from the advisory committee meeting to the PDUFA date.
  • More Avandia Drama – The New York Times reports that a prominent physician at the University of Texas sent confidential information to Avandia‘s maker, GlaxoSmithKline regarding an unpublished and confidential article slated for publication in The New England Journal of Medicine.    This has stirred the Avandia pot again and led Senator Charles Grassley to write yet another in a long series of letters regarding the regulation of drugs.
  • Subpoenas on Ketek – And speaking of Congressional oversight of FDA, according to a release, "the Energy and Commerce Committee’s Subcommittee on Oversight and Investigations unanimously approved the issuance of subpoenas for the testimony of two current and one former criminal investigator of the Food and Drug Administration (FDA) for a hearing on February 12, 2008."  For those who have antibiotics in the pipeline, this is a situation to watch closely. 

That’s it for me this week.  From a very wet and rainy Washington, D.C., have a good week everyone. 

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