The Genetic Alliance’s Terry said that Obama “has surrounded himself with Nobel Laureates and seasoned domain experts to advise the campaign,” and she called the emphasis on science as a primary domestic agenda “unprecedented.” Genetic Alliance views the campaign’s specific set of advisors as representatives of “a tipping point” for genetics and genomics in public policy, she added.
The president-elect also introduced last year a genomics and personalized medicine bill that, in its 2008 form, would promote genomics and pharmacogenomics studies in government, offer tax credit incentives for genomics research, would start a biobanking initiative, and would aim to develop some oversight for genetic testing.
This bill expired last year and was re-introduced this year by Representative Patrick Kennedy (D – RI) and will be a priority, Hughes said at a meeting on Capitol Hill in July with the Genetic Alliance.
Hughes also said at that meeting that some parts of the bill could be done through other channels if Obama were to win the White House. Terry thinks that the new president could use the executive order privilege “to make things happen quickly and to enforce a sound public approach that could have a profound impact.”
The Kennedy bill would create a Genomics and Personalized Medicine Interagency Working Group that would include the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control and Prevention, and other groups outside of the Department of Health and Human Services.
The National Biobanking Initiative would create a database for collecting and integrating genomics and environmental health data and information. Another section would use funding to improve diagnosis of genetic diseases, and for treatment and counseling. Rep. Kennedy also has added a tax credit for research expenses incurred in the development of a companion diagnostic test.
“As the bill identifies, incentives are necessary for us to realize the potential of personalized medicine,” PMC’s Miller explained. Miller also said that two other ideas PMC has proposed are in one version of the act, including a tax credit for R&D costs and “a streamlined process through FDA for drug-diagnostic tests for pharmaceuticals.”
The bill also proposes using a matrix of oversight for regulating genetic and pharmacogenomic tests, which Terry calls “a mindful approach” that is aware “of the need not to over-regulate this emerging technology.”
“Obama has been one of the foremost leaders in considering genomics and personalized medicine, and this is a great opportunity to work with an administration that’s aware of these issues,” BIO’s Pritchard added.
As an example, Pritchard said, “The genomics bill has specific provisions, and that’s why we can have this conversation about what can be enacted, legislative or executive.”
The Obama administration also is expected to continue the Personalized Health Care initiative that was started by current Department of Health and Human Services Secretary Michael Leavitt. That program aims to link clinical and genomic information, support genetic information discrimination law, ensure accuracy and validity of genetic tests, and develop common policies for access to genomic databases.
Terry told GWDN that the Obama campaign said it expected to continue the PHC initiative at least beyond the beginning of 2009, and that Genetic Alliance hopes that the new administration will “bring discipline and focus to the program” and will be able to effect real change that makes a difference in real health outcomes.
“Personalized medicine could become a catch phrase that becomes a parking lot for hype,” Terry warned. “It is essential it is grounded in the needs of real patients and real healthcare providers – it is transformative, but only when it is also practical and accessible,” she said.
Take care,
Ann
AI
