[Congressional Record (Bound Edition), Volume 160 (2014), Part 10]
[House]
[Page 14115]
[From the U.S. Government Publishing Office, www.gpo.gov]




            THE FDA CREATES ROADBLOCKS ON THE PATH TO CURES

  (Mr. BURGESS asked and was given permission to address the House for 
1 minute and to revise and extend his remarks.)
  Mr. BURGESS. Madam Speaker, the Committee on Energy and Commerce has 
embarked upon an ambitious plan to advance the cures of the 21st 
century and to make them a reality for today's patients and physicians.
  I spent, indeed, part of August doing roundtables for the Energy and 
Commerce Cures initiative. One issue that came up time and again is the 
potential, the promise of genomic medicine to understand, diagnose, 
treat, and prevent illness if given the opportunity.
  The era of precision medicine is at hand, and doctors need to have 
the tools, the tools to utilize this. One of the tools is known as 
laboratory developed tests in order to identify best therapies for a 
specific patient, but burdensome regulation by the Food and Drug 
Administration of laboratory developed tests would prevent clinical 
labs from developing tests to respond to public health needs.
  I actually believe the Food and Drug Administration has no authority 
to regulate laboratory developed tests, and in fact, if they continue 
to do this, it will only create more roadblocks, more obstacles on our 
path to cures. As a physician, I am adamantly opposed to this.
  This week, the Energy and Commerce Committee will hold a hearing on 
the future of laboratory developed tests. We must work together to 
oppose the Food and Drug Administration's proposal, so that the work of 
medical professionals, which is to heal our patients using all the 
tools at our disposal, may finally be realized.

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