Food and Drug Administration Reform Act of 2012

Floor Speech

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Representative BILBRAY and Representative SPEIER, and share my concerns about the Food and Drug Administration's draft guidance on Research Use Only and Investigational Use Only products.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 If another such public health threat became a serious concern, this draft guidance could block the development and deployment of new diagnostics urgently needed during a national crisis.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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