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With GINA Now Law, Aide Reaffirms Obama's Commitment to Genomics Bill

WASHINGTON, DC (GenomeWeb News) – The US Senate could later this year take up a genomics bill introduced last year by presumptive Democratic presidential nominee Sen. Barack Obama, according to Obama’s health policy advisor, Dora Hughes.  
 
Hughes told a Genetic Alliance meeting on Capitol Hill yesterday that Obama “remains committed” to seeing that the bill, the Genomics and Personalized Medicine Act of 2007 (S. 976), which would focus on genetic testing, is passed, although she could not yet specify when it would make it into committee because of conflicts with the Laboratory Test Improvements Act (S. 736), a bill sponsored by Sen. Edward Kennedy (D – Mass).
 
The Genomics and Personalized Medicine Act of 2007, designed to “secure the promise of personalized medicine” by expanding and accelerating genomics research and initiatives, was introduced in March of last year by Sen. Obama (D – Ill) and co-sponsored by Sen. Richard Burr (R – NC).
 
Both the Obama bill and the Kennedy bill were referred to the Senate Committee on Health, Education, Labor, and Pensions in March 2007, where they have remained.
 
After the passage of the Genetic Information Nondiscrimination Act in May, Hughes explained, Obama and his staff aimed to get the genomics and personalized medicine bill moving once again. 
 
Hughes said that when Obama “first said he wanted to do a genomics bill, he [also] said, ‘but I don’t want it to go anywhere until GINA passes.’” 
 
Kennedy’s absence from the senate over the past month due to illness could have slowed the progress of both bills, Hughes said, dampening hopes that either one could make it to a committee markup meeting before the Senate’s August recess.
 
Hughes spoke at the Genetic Alliance’s “Genetics Day on the Hill,” which was punctuated by a victory talk from Representative Louise Slaughter (D – NY), who first introduced GINA into Congress 13 years ago.
 
Referring to the many years it took to get GINA passed, Slaughter said, “we had no idea that we would run into such a maelstrom” of difficulty and opposition. “Every two years we would introduce it … and at every juncture we would get more co-sponsors than we needed to pass the legislation,” she explained.
 
But, she lamented, “the Chambers’ of Commerce didn’t like it, the drug companies didn’t like it … it was almost impossible to believe the interference we got.”
 
The Genomics and Personalized Medicine bill has four main parts. It would create a Genomics and Personalized Medicine Interagency Working Group made up of Department of Health and Human Services institutes and agencies such as the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control and Prevention, as well as groups outside of HHS.
 
The bill also calls for a National Biobanking Initiative that would create a database for the collection and integration of genomics data and environmental and clinical health information.
 
Another section of the legislation calls for funding to improve training for genetic disease and disorder diagnosis, treatment, and counseling. 
 
The fourth part of the bill, which Hughes said contains “all of the contentious issues” that will require work with Kennedy, would encourage development of companion diagnostics by drug sponsors and by device companies.
 
This section also calls for the creation and implementation of a decision matrix “to improve the oversight and regulation of genetic tests, including pharmacogenomic and pharmacogenetic tests,” the bill states.
 
The Obama and Kennedy bills differ in their proposed regulation of genetic tests, an issue that is “contentious for many stakeholder groups,” Hughes said.
 
But, she added, “We’ve been trying to move forward in terms of not bogging down the bill with those politics.” She said that Senator Burr’s office has been focused on measures in the bill that offer the most benefit and can find broad bipartisan support.
 
Hughes admitted that in spite of these efforts, there is no guarantee that the bill will move to a vote this year. She added, however, that “if Senator Obama is in the White House next year then a lot of this we can do without a bill.”

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