Obama bill could jumpstart the setting of sound genetic public policy

Washington, DC - August 04, 2006 - Sen. Barack Obama (D-IL) yesterday introduced legislation to improve development and appropriate use of genetic tests in the United States, the Genetics and Public Policy Center has learned.

"The Obama bill accelerates advances in the beneficial applications of genetic technologies to human health, while ensuring appropriate safeguards for the quality of genetic testing," says Center Director Kathy Hudson. "After decades of policy lagging behind genetic science, we are hopeful that discussion of this bill will jumpstart the setting of sound genetic public policy."

The bill addresses a number of the Center’s primary concerns, including:

Supporting and expanding research to extend genomic knowledge;

Accelerating translation of genetic tests into clinical application and clinical practice;

Enhancing genetic testing quality by creating a genetic testing specialty under CLIA;

Promoting transparency by requiring information about genetic tests and their performance characteristics to be publicly available;

Directing HHS to develop a risk-based framework for review of genetic tests; and

Supporting the development and dissemination of genetic testing guidelines for health professionals. =>

Under the Obama bill, S. 976, Congress would solicit outside expert advice before further regulation of genetic testing and genomics. The HHS Secretary is to contract with the Institute of Medicine to study and make recommendations on the key issues. Once the report is submitted, the Secretary is to develop and propose a decision matrix to help labs and other test makers know which types of tests require which level of review and who is responsible for the review––CMS or the FDA, or both. The bill also requests a study by the National Academies of Sciences on incentives to stimulate advances in designing and developing new genetic testing technologies.

As Obama’s health policy advisor, Dora Hughes, MD, MPH, explained in the ACLA audio conference, the Senator’s approach is to "fashion an overall strategic plan" addressing not only federal oversight, but also the need for increased federal support for research, data collection and sharing, genomics training of the medical workforce, and monitoring of direct-to-consumer marketing practices. ACLA supports the Obama bill, noting in particular that it recognizes these "interlocking needs."

As part of this strategic plan, Hughes said, the bill would create an interagency working group to expand and accelerate genomics research in public and private sectors through enhanced communication, collaboration, and integration of relevant activities. It also would require HHS to establish a national database for genetic test information sharing.