Weekly Roundup – 12/15/06

J0401613 The 109th "Do Nothing" Congress has called it quits.  They are headed into the sunset.  But before they left, there was a lot of last minute bill-passing to make up for their lack of drive during the past two years, one supposes.  It was an eventful week with the confirmation of the FDA commissioner and a flurry of activity, if not of snow.

  • Workshop on FDA Clinical Trial Statutory and Regulatory Requirements Announced – The FDA announced a 2-day workshop  set for February 7 and 8 in San Diego is for the clinical research community and targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA-regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA.
  • Advisory Committee Meetings Held on Ketek – The FDA held AC meetings to discuss safety issues associated with Ketek on Thursday and today, Friday.  Meanwhile, Senator Grassley appears nearly apoplectic, voicing the opinion that the FDA withheld important safety information from the original advisory committee considering Ketek for approval.  It’s a mess. 
  • GAO Reports Inadequate Ability of FDA to Screen DTC – In a dog bites man story, the GAO released a report outlining deficiencies in the ability of the agency to screen DTC.  Hence the PDUFA negotiations that have been taking place that would address the problem.  The report is coming out after the effort by the agency to beef up their ability to do so by charging higher PDUFA fees. 
  • Screening Test for Chagas Disease in Blood Donors Approved by FDA – The agency this week approved a new test to screen blood donors for a blood-borne parasite that causes Chagas disease, a serious and potentially fatal parasitic infection. The test, called the ORTHO T. cruzi ELISA Test System, detects antibodies to the Trypanosoma cruzi (T. cruzi) parasite and is the first such test approved by FDA.  The ORTHO T. cruzi ELISA Test System is manufactured by Ortho-Clinical Diagnostics, Inc., Raritan, NJ
  • Ryan White CARE Act Reauthorized – Congress finally voted and the President signed a reauthorization for three years. 
  • Scott Gottlieb Sets Departure – One of the snappier dressers in government (though there aren’t many) has announced his departure from FDA in January.  Dr. Gottlieb intends to return to the American Enterprise Institute.

That’s it for this week folks.  Have a wonderful weekend.  See ya next week. 

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