[Congressional Record Volume 158, Number 80 (Thursday, May 31, 2012)]
[Extensions of Remarks]
[Page E933]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




            FOOD AND DRUG ADMINISTRATION REFORM ACT OF 2012

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                               speech of

                          HON. EDOLPHUS TOWNS

                              of new york

                    in the house of representatives

                        Wednesday, May 30, 2012

  Mr. TOWNS. Mr. Speaker, I rise today to echo the comments of my 
colleagues, Representative Bilbray and Representative Speier, and share 
my concerns about the Food and Drug Administration's draft guidance on 
Research Use Only and Investigational Use Only products.
  This guidance provides no flexibility for tests used infrequently, 
for example, to identify rare disorders. Rare diseases, such as Gaucher 
Disease and Fragile X, can be hard to diagnose, but genetic tests 
developed and validated by laboratories have made them much easier to 
identify. In some instances, these tests can point the way to 
successful treatment of the underlying condition.
  Emerging public health threats are another key area that could be 
impacted by this guidance. Three years ago, this country dealt with the 
H1N1 flu virus, an emerging infectious disease. If another such public 
health threat became a serious concern, this draft guidance could block 
the development and deployment of new diagnostics urgently needed 
during a national crisis.
  It is critical that the FDA consider these serious and valid concerns 
before issuing a final guidance on Research Use Only or Investigational 
Use Only products.

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