[Congressional Record Volume 158, Number 80 (Thursday, May 31, 2012)]
[Extensions of Remarks]
[Page E930]
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. JACKIE SPEIER

                             of california

                    in the house of representatives

                        Wednesday, May 30, 2012

  Ms. SPEIER. Mr. Speaker, I rise today to share my additional thoughts 
on the Food and Drug Administration (FDA) issue raised by my colleagues 
Mr. Bilbray and Mr. Towns. 
  The Research Use Only (RUO) and Investigational Use Only (IU0) 
products draft guidance issued by the FDA last June could result in 
serious consequences for the future of health care. Patients and 
doctors want access to validated tests that will guide and improve 
their medical care. The development of tests by laboratories and their 
validation and regulation under the Clinical Laboratory Improvements 
Act (CLIA) are part of a long-standing regulatory framework. I am 
concerned that this draft guidance, should it be finalized in its 
current form, could seriously disrupt this process and the development 
of new technologies and diagnostics.
  Another concern about the FDA draft guidance is that manufacturers 
could be held accountable for the activities of their customers who 
purchase these RUO and IUO products. It is quite possible that the 
draft guidance will cause manufacturers to stop offering important 
components for diagnostic tests. And what would be the end result? 
Commercial, academic, and public health laboratories may not be able to 
continue current tests or develop new tests to help diagnose or prevent 
the progression of diseases and conditions such as cystic fibrosis, 
ovarian cancer, organ failure and transplantation, and identifying new 
infectious organisms.
  The FDA must consider the potential impact of this guidance on the 
practice of medicine and patient access to new and existing 
diagnostics. The concerns raised by the health care community, 
including the American Hospital Association and the Association of 
Public Health Laboratories, should be addressed before finalizing this 
guidance.

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