Drug approvals in the U.S. are delayed by inefficiency and politics

The Food and Drug Administration's effectiveness in getting drugs approved for market is beset by inefficiency and politics, says Henry I. Miller of the Hoover Institution.

The average time to bring a drug to market is now 15 years, (more than double the average time since 1964), in spite of pharmaceutical companies plowing more dollars into research and development, along with better technologies for developing new drugs. The delay is due largely in part to the FDA. According to the Tufts Center for Drug Development:
 

• FDA officials are so risk-aversive that they will take all measures to prevent approving a product that turns out to be harmful; however, in the process, they are delaying approvals of beneficial products.
   
• The FDA has recently denied drug companies their request to allow multiple trademarks for the same drug (such as Sarafem/Prozac or Propecia/Proscar).
   
• FDA officials are overtly political, and will retaliate towards drug companies that complain about their inefficiency; such a retaliation can result in months or years of delay in approving a drug.
  
  Dr. Mark McClellan, a doctor and health economist has been in place as the new head of the FDA for a year, has brought some changes to the FDA, such as putting an end to a "stop the clock" procedure that the FDA would use when reviewing new drug applications in order to make approval times look shorter.
  
  Dr. McClellan has also advocated the use of more relevant testing for a drug's efficacy, known as "surrogate end points," such as scans or blood tests that evaluate a drug's ability to shrink a tumour.
  
  Still, says Miller, much more work needs to be done at the FDA, and Dr. McClellan could be key in instituting further reforms.
  
  Source: Henry I. Miller, Can Dr. McClellan Cure the FDA? Hoover Digest, No. 1, 2004, Hoover Institute.
  
  For article text http://www.hooverdigest.org/041/hmiller.html
  
  For information from the Tufts Center for Drug Development: http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=4
  
  For more on Health Issues (Reforming the FDA) http://www.ncpa.org/iss/hea/
  
  FMF Policy Bulletin\20 April 2004