[Congressional Record (Bound Edition), Volume 153 (2007), Part 6]
[Senate]
[Page 7593]
[From the U.S. Government Publishing Office, www.gpo.gov]




                 GENOMICS AND PERSONALIZED MEDICINE ACT

  Mr. BURR. Mr. President, I rise today to express my support for S. 
976, the Genomics and Personalized Medicine Act of 2007, which my 
distinguished colleague from Illinois, Senator Obama, and I introduced 
on March 23, 2007. Senator Obama introduced this legislation last year. 
We have worked together on some revisions, and I am proud to join him 
in cosponsoring the legislation this year.
  I believe this legislation will help improve the quality and safety 
of health care by providing a better understanding of what causes 
certain diseases. Through a coordinated research initiative and safer 
genetic tests, patients and doctors will be empowered to make more 
informed decisions about medical treatments.
  This bill will advance the study of human genes and their functions 
to better predict patients' susceptibility to certain diseases or 
conditions and better customize drugs and medical treatments to meet 
patients' unique needs. By facilitating genomics research, fostering a 
capable genomics workforce, and encouraging the development of high 
quality genetic tests, patients will be better informed about the 
medical care they need.
  I am proud that North Carolina is a leader in genomics and 
personalized medicine research. Duke University's Institute for Genome 
Sciences and Policy and the University of North Carolina at Chapel 
Hill's Institute for Pharmacogenomics and Individualized Therapy are 
both conducting significant research efforts in this area and support a 
stronger Federal focus on genomics. This legislation will increase 
Federal support for initiatives at Duke and Chapel Hill--a win-win for 
North Carolina and patients.
  Specifically, this bill establishes an Interagency Working Group at 
the U.S. Department of Health and Human Services to pull together and 
accelerate genomics research by developing standardized terminology and 
establishing quality standards and guidelines for the collection, 
processing, and storage of genomic samples and data. It advances 
genomics research by establishing a national biobanking distributed 
database that collects and integrates genomic data to simplify pooled 
data analysis. The bill also develops biobanking initiatives at 
academic medical centers across the country, including biobanks 
containing biological specimens. It will improve genetics and genomics 
training by developing model training programs, residency curricula and 
teaching materials, and by integrating genetics and genomics into 
clinical and public health practice by developing health professional 
guidelines.
  The bill will also encourage drug sponsors and device companies to 
develop companion diagnostic tests, and it will improve Federal 
oversight and regulation of genetic tests by identifying which tests 
require review and which agency--the Centers for Medicare and Medicaid 
Services or the Food and Drug Administration--should have oversight 
over specific categories of tests. It requires the Centers for Disease 
Control and Prevention to evaluate direct-to-consumer marketing of 
genetic tests to which consumers have direct access and to educate the 
public about genomics and its applications. It also asks the Agency for 
Healthcare Research and Quality to assess the clinical utility and 
cost-effectiveness of companion diagnostic tests that guide prescribing 
decisions.

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