The Genomics and Personalized Medicine Act

This summer marked the 10^th anniversary of the sequencing of the human genome.  In the course of these ten years, advances in genomic technologies have begun to bring forth the promise of personalized medicine to the clinic.  And as this clinical utility continues to expand, our national legislative priorities will also need to reflect this change in medical practice and create regulatory policies that support creation and adoption of targeted therapeutics and personalized medical programs.

The coming of August starts to signal the close of summer, and with it, the August recess for Congress when our representatives head back to their districts to spend time with their constituencies. However, with the mid-term elections only months away, this August recess also signals a slowdown of legislative efforts and a focus on campaigns. Among the unfinished business that will remain after the 111^th Congress closes and the 112^th is elected is HR 5440, the Genomics and Personalized Medicine Act of 2010.

The Genomics and Personalized Medicine Act of 2010 is an effort to accelerate research, coordinate federal activities across agencies, and ensure delivery of personalized medicine to the American public.  The bill would help guide this new age of discovery and medicine in the second decade beyond the sequencing of the genome.

Built upon then Senator Obama’s Genomics and Personalized Medicine Act of 2006, HR 5440 attempts to expand the provisions of the 2006 version by mandating the creation of the Office of Personalized Healthcare under the Secretary of Health and Human Services.  This office will be the point for policy coordination regarding personalized medicine strategic planning, education, coverage and reimbursement, and product regulation.  The bill will provide $150 million in funding for personalized medicine research grants linking genetic profiles with individuals’ biospecimens.  The bill would also strengthen the FDA’s regulatory authority in this area, clarifying requirements for diagnostic tests and potentially allowing FDA to require companion diagnostic tests for new drugs entering the market.

Currently the bill has received little notice in Congress, having only six cosponsors, despite it being a high priority of then Senator Obama in 2006.  In addition, this bill will face another hurdle in moving forward, as it was introduced by Rep. Patrick Kennedy who will not seek reelection this year.  In the next Congress a legislative champion will need to be identified to introduce the bill, much less generate momentum to move the bill forward.

Legislation moves slowly – the science of personalized medicine, however, does not.  If this past decade has shown us anything, it is that genomic technologies are rapidly moving towards clinical applications.  Establishing the appropriate legislative and regulatory frameworks to fully capitalize on the potential of our scientific advances can contribute greatly to the overall healthcare goals of our nation.  Researchers, clinicians, and advocates will all need to play a role in educating our legislators and policymakers of the importance of good policy that supports personalized medicine and disruptive innovations. Strong encouragement to reintroduce legislation supporting personalized medicine policy will need to be emphasized by all parties involved in improving health.