INDUSTRY NEWS
The personalized medicine movement recently got a major proponent on Capitol Hill. Senator Barack Obama (D–IL) introduced the Genomics and Personalized Medicine Act of 2006 (S. 3822). The bill proposes to increase funding for research on genomics, expand the genomics workforce, provide a tax credit for the development of diagnostic tests that can improve the safety or effectiveness of drugs, and reaffirm the need to protect genetic privacy.
“What’s already happening in the area of genomics itself and what will likely happen in the next 5–10 years touches on a number of Senator Obama’s health priority issues,” says Dora Hughes, MD, the senator’s health and education policy advisor. “So it was a natural for him to pursue this issue further.”
According to Obama aides, the bill would create incentives to accelerate private-sector innovation in genomics. The legislation seeks to spur such innovation by allocating $150 million for research in genomics. It also provides a 100% tax credit for private research to develop companion diagnostic tests that can improve the effectiveness or safety of certain drugs. In addition, this bill would modernize FDA’s outdated process for reviewing genomic tests.
“The companion diagnostic test credit is a major fixture in the bill,” says Hughes. “The senator recognizes that the private sector has championed the genomics area. We expect that as we continue to develop more of these tests and treatments, we will continue to rely appreciably on the private sector to make the investment.”
Obama aides said that while the incentive takes the form of a tax credit in the bill, what it ultimately may be in the legislation that passes is still unclear. Other suggestions include an extension of patent protections and market exclusivities. The National Academy of Sciences (Washington, DC) has expressed an interest in formally studying the incentive issue; it has already conducted a study on genome patent law. The Institute of Medicine (Washington, DC) is also developing a genome roundtable, and it may be willing to discuss this issue.
“No one is sure what the final incentive will be,” says Hughes. “There are a number of risks that the companies will take. While obviously there are a number of benefits for them as well, this will be an important way to continue to accelerate work in the genomics area. Hopefully we will be able to collaborate with other senators to develop a bipartisan compromise bill. It’s hard to predict what the other senators’ priorities will be and what preferences they will have with regards to the incentive. But Senator Obama will continue to support the inclusion of a section on some type of financial incentive for the private sector.”
The bill has been referred to the Senate Committee on Finance, largely because of the tax credit provision. The other sections of the bill have been referred to the Senate Committee on Health, Education, Labor, and Pensions. Obama aides believe that it is highly unlikely that the bill will pass this year. Nonetheless, the senator and his staff will continue to increase awareness and education about the genomics issue, and work with outside groups to refine the bill’s provisions even further. They also plan to work with other senators on a bipartisan level to develop a compromise bill that will be introduced and hopefully passed in 2007.
“There’s enough interest and activity going on in this area, whether it’s the hearings on direct-to-consumer genetic tests by Senator Gordon Smith (D–OR) or the bill on laboratory-developed tests by Senator Edward Kennedy (D–MA),” says Hughes. “So it’s reasonable to expect that the parties will come together, plus a number of others who’ve expressed interest privately to develop a compromise bill.”
The bill can be accessed via the following Web site: http://thomas.loc.gov/cgi-bin/query/z?c109:s.3822:. More information about Senator Obama’s involvement in this bill can be accessed at his Web site at http://obama.senate.gov/.
