NCPA - National Center for Policy Analysis


June 18, 2010

Caution at the federal Food and Drug Administration (FDA) impacts patient health, undermining our ability to treat people earlier, according to a new paper from Tomas Philipson, a University of Chicago professor, and Eric Sun, a Stanford University physician. 

In their "Cost of Caution: The Impact on Patients of Delayed Drug Approvals," Philipson and Sun look at various attempts to reduce the time delay, including the user fees created by the Prescription Drug User Fee Act of 1992. 

Though criticism of the FDA isn't new, Philipson and Sun take an unusual tact: they focus on three medications (for HIV, breast cancer, and non-Hodgkin's lymphoma) and calculate the social benefit to the patients of these drugs -- and then the benefits had these meds come to market earlier.  

The paper concludes with some suggestions for reforms at the FDA: 

  • Allowing the payment of stipends to clinical-trial volunteers -- facilitation of recruitment by such measures would help clear the present bottlenecks, while having a minimal effect on the safety of participants.
  • Adopting technologies such as biomarkers, which offer the potential to accelerate clinical trials -- these would have special value in the case of diseases such as multiple sclerosis that progress slowly to clinical endpoints such as disability; to ensure no reduction in safety, the FDA could require trials employing biomarkers to meet a higher evidentiary standard.
  • Strengthening the Prescription Drug User Fee Act -- after an initial improvement in FDA processing rates resulting from the hiring of additional staff, review times stagnated; a new influx of reviewers could shorten development times further.
  • Establishing an ombudsman -- such an office could review the effects of FDA regulations and practices on the speed of drug development.
  • Strengthening the financial position and authority of the Reagan-Udall Foundation -- that independent body is charged with setting up projects and programs that assist the FDA in modernizing the drug development process while continuing to serve its obligations to the public. 

With so much focus on the larger issue of health care, reforming the FDA hasn't received much attention inside or outside the administration.  Philipson and Sun remind us of the importance of this issue and offer a reasonable prescription. 

Source: David Gratzer, "Making the FDA More Patient-Friendly," Frum Forum, June 16, 2010. 

For study: 


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