Institutional barriers (e.g., limitations on product reimbursement, unclear regulatory requirements and occasional government redundancies) have been faulted for relatively slow progress toward wide spread implementation of personalized medicine. In an effort to improve access to and appropriate utilization of valid, reliable genetic tests and to secure the promise of personalized medicine for all Americans, then-Sen. Barack Obama, D-Ill., introduced the Genomics and Personalized Medicine Act in 2006 during the 109th Congress. Most recently, Reps. Patrick J. Kennedy, D-R.I., and Anna Eshoo, D-Calif., introduced H.R. 5440, the 2010 version of the bill.
The Centers for Disease Control and Prevention (“CDC”), located within the federal Department of Health and Human Services (“HHS”) is seeking public comments, data or other information to assess the current research, policy and practice environment in public health genomics. 2011-16422.pdf The information is solicited to assist the Office of Public Health Genomics (“OPHG”) of the CDC with its strategic plan to integrate genomics into public health research, policy, and programs with the goal of improving the health and well being of the public. Electronic or written comments must be received on or before August 1, 2011.
On June 23, 2011, the United States House of Representatives passed the “Leahy-Smith America Invents Act” (H.R. 1249) to amend title 35 of the United States Code, to provide for patent reform. Within the numerous provisions related to the examination, administration and enforcement of U.S. patents is a proposed amendment that may affect the value of genetic testing patents. Under Section 27 of H.R. 1249 the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent Office (Director) shall report to Committee of the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives on effective ways to conduct independent confirmatory genetic tests (second opinions) of genetic diagnostic tests covered by patents that are exclusively licensed.
Personalized Medicine seeks to individualize health care by identifying the most effective or most comfortable treatment for that individual. Finding the right treatment for the right individual at the right time can be applied preventively or therapeutically to treat disease. In one aspect of personalized medicine, an individual’s genetic code is analyzed and used to identify the individual’s disease risk so that a healthcare strategy can be implemented that focuses on prevention or early intervention rather than a reaction to an advanced stage of disease.