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 bills were never enacted into law, but interest in the objectives of the bills have remained.  The Personalized Medicine Coalition (PMC) recently reported that Rep. Anna Eshoo wants to reintroduce a new version of the bill and requested PMC’s assistance to craft a bill that would enjoy wide community support.  To that end, the PMC organized a working group that produced recommendations to further facilitate the development of personalized medicine.

In anticipation of the bill’s reintroduction, this post will review the major initiatives of the 2010 version of the bill and report on PMC’s recommendations.

Office of Personalized Healthcare

The bill would have established an Office of Personalized Healthcare (Office) within the Office of the HHS Secretary (Secretary) to coordinate the activities related to genomics and personalized medicine of HHS and other relevant federal agencies, as well as private and other public entities. The Office would have oversaw selected initiatives to realize the overall goals of the act, such as the development of a long-term strategic plan to advance personalized medicine.

The Office also would have coordinated efforts and prepared recommendations for a clear delineation between the roles and responsibilities of the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services in the regulation and enforcement of products used for personalized medicine, including laboratory-developed tests, and the resolution of any conflicts or redundancies between the two agencies

Expansion and Acceleration of Research for Genomics and Personalized Medicine

The Secretary would have been able to award grants to entities to increase and accelerate research and programs to collect, evaluate and disseminate genetic and genomic data. In addition, the director of the National Institutes of Health, in consultation with the director of the Centers for Disease Control and Prevention, would have established and maintained a national biobank to advance the field of personalized medicine.

Committee on the Evaluation of Genomic Applications in Practice and Prevention

An advisory committee would have been formed to committee to analyze current literature to expand and accelerate knowledge related to the clinical validity and utility of genomics and personalized medicine.

Realizing the Potential of Personalized Medicine

The bill also provided the means to study of barriers to the implementation of personalized medicine through various avenues.  For example, the Secretary would have:

  • Established a committee to carry out a comparative analysis of laboratory requirements to the end of reducing redundancy.
  • Established a committee including representatives of the private sector to examine barriers in research, regulation and reimbursement for medical product development for personalized medicine.
  • Entered into an agreement with the Institute of Medicine to provide an independent, external review of the current billing, coverage and reimbursement methods for products and services used for personalized medicine.

The bill also encouraged the development of companion diagnostic tests and products in connection with the submission of investigational new drug products. Additionally, the bill would have implemented a review and analysis of the public health impact of direct-to-consumer marketing and access to products used for personalized medicine.

PMC Recommendations

As reported in the PMC’s policy brief, the following specifications are recommended:

  • Create a stable and predictive regulatory environment for personalized medicine.
  • Provide research and development tax credits for companies developing personalized medicine drugs and diagnostics.
  • Ensure that federal committees have adequate representation of personalized medicine experts.
  • Ensure patient access to personalized medicine through Medicare coverage.
  • Require the Center for Medicare and Medicaid Innovation to test programs that would promote personalized approaches to health care.

Market  Incentives to Promote Personalized Medicine

The PMC’s workgroup will also examine how to best structure market incentives and develop reimbursement framework for genetic counseling services.  The group also reports that it has long advocated for a patent expansion or market exclusivities to help incent developers pursue personalized medicine product development.  Such market and development incentives may become more important as patent protection for technologies that cover personalized medicine are under review in the courts.