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.

I was introduced to the concept of personalized medicine by former U.S. Food and Drug Administration (FDA) Commissioner, Dr. Andrew von Eschenbach. His keynote speech “The Future of Innovation from the FDA Perspective” at the 2007 BayBio annual conference (a Northern California Life Science Association) outlined the FDA’s interest in the use of biomarkers to reduce adverse events and streamline the drug approval process.  My personal legal practice exposed me to the use of biomarkers to match a chemotherapeutic treatment to the right individual; however, I was previously unaware that the promise of personalized medicine was so strongly embraced by the FDA.

Indeed in 2006, then Senator Barack Obama introduced the “Genomics and Personalized Medicine Act of 2006” (S.3822) that sought to improve access to and appropriate utilization of valid, reliable and accurate molecular genetic tests by all populations, thus helping to realize the promise of personalized medicine.  The Act was not enacted into law, but was reintroduced in subsequent Congressional sessions.  More recently, in May of 2010, Congressman Patrick Kenney and Congresswoman Anna Eshoo reintroduced the fourth version of a personalized medicine bill into the U.S. House of Representatives  “The Genomics and Personalized Medicine Act of 2010.”  This bill also failed to pass into law, but is likely to be reintroduced during this year’s Congressional session.

The contributors to this blog will follow this legislation and related legal developments, as the promise of personalized medicine becomes reality.  In addition to the possible reintroduction of the bill, this blog will review:

  • Intellectual property issues, including court challenges to the patenting of genes, polymorphisms and diagnostic methods that utilize genetic information to diagnose and treat disease;
  • FDA regulation of companion diagnostics and direct-to-consumer (DTC) genetic tests;
  • Reimbursement, cost-sharing and payor issues regarding diagnostic tests;
  • Privacy and regulated use of a patient’s genetic information; and
  • Development and implementation of health care information technology (IT) devices and services.

Much progress has been made in the science and regulation of personalized medicine since my introduction to the FDA’s vision of its promise.  We hope to monitor and report this progress and provide a resource to those watching the developments in this emerging field.