Public Laws | Pending Legislation
Genomics and Personalized Medicine
Genomics has the potential to revolutionize the practice of medicine. The completed sequencing of the entire human genome in 2003 through the Human Genome Project (HGP) has facilitated better understanding of disease causation. However, despite this breakthrough, very few genomics-based tests or treatments have reached the public. In 2007, Senator Barack Obama (D-IL) reintroduced legislation that he had introduced in the 109th Congress to overcome the scientific barriers, adverse market pressures, and regulatory obstacles that have impeded the development of better treatments.
Scientists are only beginning to understand how our genetic makeup affects our propensity for disease and how we will respond to treatment. Moreover, the HGP has expanded the focus from the science of genetics, which refers to the study of single genes, to include genomics, which describes the study of all genes in an individual, as well as the interactions of those genes with each other. The role that environmental factors play in promoting disease and the potential influence they have at the genetic level is also an area of great interest to researchers. Today, the typical blockbuster drug is effective in only 40–60 percent of patients, and serious adverse drug reactions impact 2.2 million people in the United States, killing an estimated 100,000 a year.
Genomics could eventually help predict which individuals will become ill, enable earlier diagnoses, and screen patients to determine which treatments will be most effective and safest. Doctors may apply this knowledge to personalize drug treatment to an individual patient’s genetic makeup, significantly improving health care outcomes and quality. Drug manufacturers will be able to be better anticipate which new treatments will work, accelerating the drug discovery process.
Provisions of the Legislation/Impact on NIH
S. 976 would require the Secretary of Health and Human Services (HHS) to establish the Genomics and Personalized Medicine Interagency Working Group (IWG). Among other duties, the IWG would develop guidelines for procedures, protocols, and policies safeguarding the privacy of biobank subjects, in accordance with the Office for Human Research Protections and the Clinical Research Policy Analysis and Coordination Program at the National Institutes of Health (NIH). The bill would set aside $1 million to support the IWG for fiscal years (FYs) 2008 and 2009.
The bill would also authorize the Secretary of HHS to establish a national biobanking database, biobank initiatives grant program, and mechanism for management and submission of pharmacogenomic data developed by the Food and Drug Administration (FDA) in collaboration with NIH and the Centers for Disease Control and Prevention. The bill proposes language that would modernize FDA and the Centers for Medicare & Medicaid Services by requiring these agencies to study and update regulatory processes to ensure the quality of genomic tests through improved oversight and regulation. To support the programs under the National Biobanking Initiative, the bill would set aside $75 million for FY 2009.
The Secretary would also be required to conduct studies in order to realize the potential of personalized medicine by accelerating genomic research and increasing understanding of how genomics interacts with environmental factors to cause disease in order to speed development of accurate diagnostics and treatments. The bill would protect consumers by reaffirming the commitment of Congress to the prevention of genetic discrimination and protection of genetic privacy. In addition, direct-to-consumer marketing of genetic tests would receive greater scrutiny and regulation, for which the bill would appropriate $10 million for FY 2008.
Status and Outlook
S. 976, the Genomics and Personalized Medicine Act of 2007, was introduced by Senator Obama on March 23, 2007, and was referred to the Senate Committee on Health, Education, Labor and Pensions. This measure is similar to S. 3822, which was introduced by Senator Obama late in the 109th Congress. Upon its initial introduction in 2006, S. 3822 had no cosponsors and little chance to be acted upon before the second session ended. In contrast, S. 976 is cosponsored by Senator Richard Burr (R-NC) and has received support from various coalitions interested in this issue. No further action has occurred on this legislation.