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Public Statements

Food and Drug Administration Reform Act

Floor Speech

Location: Washington, DC


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 On June 1, 2011, the Food and Drug Administration issued a draft guidance titled, ``Draft Guidance for Industry and FDA Staff--Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked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As written, this draft guidance could jeopardize the future of personalized medicine and individualized treatment options for patients. I also want to note that when the FDA sought public comment on this draft guidance, the agency received correspondence from 54 organizations and individuals. Every comment received by the FDA expressed concerns about the draft guidance, and not one endorsed the approach.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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