[Congressional Record Volume 158, Number 80 (Thursday, May 31, 2012)]
[Extensions of Remarks]
[Page E929]
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. BRIAN P. BILBRAY

                             of california

                    in the house of representatives

                        Wednesday, May 30, 2012

  Mr. BILBRAY. Mr. Speaker, I rise today to bring to the attention of 
my colleagues an issue of great importance to the patient and provider 
community--the availability of critical diagnostic tests. On June 1, 
2011, the Food and Drug Administration issued a draft guidance titled, 
``Draft Guidance for Industry and FDA Staff--Commercially Distributed 
In Vitro Diagnostic Products Labeled for Research Use Only or 
Investigational Use Only: Frequently Asked Questions.''
  As written, this draft guidance could jeopardize the future of 
personalized medicine and individualized treatment options for 
patients. I also want to note that when the FDA sought public comment 
on this draft guidance, the agency received correspondence from 54 
organizations and individuals. Every comment received by the FDA 
expressed concerns about the draft guidance, and not one endorsed the 
approach.
  For example, the Johns Hopkins University department of pathology 
surveyed laboratories at the university, and found that dozens of tests 
could be impacted by the guidance, including diagnostics for viral 
meningitis, and diagnosis of HIV infection in infants with infected 
mothers. Mayo Clinic indicated that certain important cancer 
diagnostics could disappear if this guidance is implemented as 
currently written. Public health laboratories, including those in my 
home state of California would lose their ability to identify and 
provide laboratory-based surveillance for diseases such as measles, 
West Nile virus, eastern equine encephalitis virus, and multidrug-
resistant tuberculosis.
  When the academic community expresses such serious reservations, I 
believe it is important that FDA review and address these concerns. It 
is important for the Agency to work with all stakeholders, including 
the patient and provider communities, on a balanced approach before 
issuing its final guidance.

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