Tough First Quarter for the FDA

J0386506I was looking over the recent posts and mulling the state of the FDA at this point.  It has been one tough first quarter for the agency and the election cycle doesn’t promise any relief.  Amazingly, the agency goes on as if what has been occurring the past few years is precisely what was intended.

Consider the following:


  • Senator Sherrod Brown asks the Congressional Research Service, a research arm of the Library of Congress, to conduct an investigation of Fast Track at FDA to see whether or not the practice of Fast Track is actually speeding the availability of drugs;
  • The Senate threatens contempt charges against HHS Secretary Mike Leavitt for refusing to turn over briefing materials that were used by FDA Commissioner Andrew von Eschenbach before his congressional testimony regarding the approval of Ketek.


  • Congressman Bart Stupak calls for the resignation of FDA Commissioner Andrew von Eshenbach;
  • The heparin issue emerges, causing Congresswoman Rosa DeLaurio to liken the FDA management to "Keystone Cops"
  • Congressman John Dingle questions the FDA role in supervising the Pfizer Lipitor ad campaign over the use of Dr. Robert Jarvik

March (which is not over)

  • Senator Chuck Grassley asks the General Accountability Office to investigate FDA’s use of Accelerated Approval and the management of post-marketing commitments by companies;
  • HHS Secretary Leavitt provides access to the Ketek documents, avoiding the contempt citation.

I don’t think Spring is going to thaw the big freeze for FDA.  Add to this formula three top presidential contenders, all of whom favor importation for drugs, which will further test the FDA, and a lot more oversight to come with Congress cracking the whip and introducing new reforms, and you have the picture – 2008 will be for the FDA even harder than 2007 and 2006.  The result in turn may be, fewer drugs approved, more approvable letters and delayed responses to new drug applications. 

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