NCPA - National Center for Policy Analysis

FDA Hampers New Drug Development

February 3, 2011

Although overall biopharmaceutical research and development (R&D) spending continues to grow, R&D spending by big drug makers peaked at $47.9 billion in 2007, falling to $45.8 billion in 2009.  This is significant because the big drug makers are the companies that can afford to spend $1 billion to get a new drug through the Food & Drug Administration's (FDA) recondite approval process, says Ronald Bailey, Reason Magazine's science correspondent.

Just how much is government slowing new drug development?  A new study by oncologist David Stewart and his colleagues at the M.D. Anderson Cancer Center in Houston, Texas, sheds some depressing light on this issue.

  • The study notes that the time from drug discovery to marketing increased from eight years in 1960 to 12 to 15 years now.
  • They calculate that five years of this increase is the result of ever tighter regulations boosting the costs and lengths of clinical trials.
  • The more stringent clinical trial regulations aim at the laudable goal of protecting cancer patients from harm, especially from death as result of drug toxicity.
  • However, the M.D. Anderson Center researchers note that toxic death rates in clinical trials have in fact not significantly decreased.

Since the government is hampering the development of new medicines, the obvious solution would be to get the government to stop doing that.  Unfortunately, the perpetrators of government failure (bureaucrats and Congress members) cannot see that they are the problem, says Bailey.

Source:  Ronald Bailey, "Government Pills," Reason Magazine, January 25, 2011.

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