On May 28, 2010, U.S. Reps. Patrick J. Kennedy (D-R.I.) and Anna Eshoo (D-Calif.) introduced H.R. 5440, the Genomics and Personalized Medicine Act of 2010 (Act). A similar bill was previously introduced by then-Senator Barack Obama (D-Ill.) during the 110th Congress. The overall goal of the Act is to realize the promise of personalized medicine by expanding and accelerating genomics research, improving the accuracy of disease diagnosis, increasing the safety of drugs, and identifying novel treatments.
The bill sets forth several initiatives, discussed below.
Office of Personalized Healthcare
The bill would establish an Office of Personalized Healthcare within the Office of the Secretary of Health and Human Services (Secretary) to coordinate the activities related to genomics and personalized medicine of the Department of Health and Human Services and other relevant federal agencies, and private as well as public entities. The Office would oversee selected initiatives to realize the overall goals of the Act, such as the development of a long-term strategic plan to advance personalized medicine. Among other things, the Office would be expected to prepare recommendations for a clear delineation between the roles and responsibilities of the FDA 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
If enacted, the Secretary may 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 establish and maintain a national biobank to advance the field of personalized medicine.
Committee on the Evaluation of Genomic Applications in Practice and Prevention
The Act would create an advisory committee to analyze current literature to expand and accelerate knowledge related to the clinical validity and utility of genomics and personalized medicine. The committee will, for example, develop or adapt processes for recognizing promising new products for the use of personalized medicine.
Realizing the Potential of Personalized Medicine
The Act calls for the study of barriers to the implementation of personalized medicine through various avenues. For example, the Secretary would establish a committee to carry out a comparative analysis of laboratory requirements to the end of reducing redundancy. A committee comprising representatives of the private sector would be established to examine barriers in research, regulation, and reimbursement for medical product development for personalized medicine. The Secretary would enter 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 Act also encourages the development of companion diagnostic tests and products in connection with the submission of investigational new drug products. Additionally, the Act would implement a review and analysis of the public health impact of direct-to-consumer marketing and access to products used for personalized medicine.
Foley will continue to provide updates related to H.R. 5440 and other developments related to the emerging personalized medicine field.
A copy of the bill can be found at http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.5440: .
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