How the US Federal Drug Administration Impedes Innovation

As the key gatekeeper for pharmaceutical and device innovation, the U.S. Food and Drug Administration (FDA) has a tough job. If it is too lenient, it will allow the sale of drugs and medical technology that could harm vulnerable Americans. Too tight, and the United States is being deprived of key innovations that could cut costs, increase health and create jobs, says Michael Mandel, chief economic strategist at the Progressive Policy Institute.

With this in mind, Mandel addresses the question: Is the FDA unintentionally choking off cost-saving medical innovation?
 

• First, Mandel discusses the difficulty of assessing whether the FDA is under-regulating or over-regulating new drugs and devices, given the desire for safety.
   
• He then shows how the FDA is applying "too-high" standards in the case of one non-invasive device currently under consideration – MelaFind, a handheld computer vision system intended to help dermatologists decide which suspicious skin lesions should be biopsied for potential melanoma, a life threatening skin cancer.
   
• Mandel then draws analogies to development of the early cell phones and personal computers.
  
  In an upcoming paper, Mandel will suggest possible remedies to the problem of FDA overregulation of innovation.
  
  Source: Michael Mandel, How the FDA Impedes Innovation: A Case Study in Overregulation, Progressive Policy Institute, June 2011.
  
  For text: http://progressivefix.com/wp-content/uploads/2011/06/06.2011-Mandel_How-the-FDA-Impedes-Innovation.pdf
  
  For more on Health Issues: http://www.ncpa.org/sub/dpd/index.php?Article_Category=16
  
  First published by the National Center for Policy Analysis, United States
  
  FMF Policy Bulletin/ 05 July 2011