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In 2010, Kennedy/Eshoo “Genomics and Personalized Medicine Act of 2010 –
HR 5440” was introduced in the US Congress. Compared to previous personalized
bills, including that introduced by Barack Obama in 2006, this bill was more
emphatic with an aim to stimulate and accelerate the research and development of
products used in personalized medicine and to move these diagnostic and treatment
modalities from the laboratory into clinical practice. This goal will be accomplished
through the establishment of a human biological specimen repository within the
NIH to increase our understanding of diseases, our environment and the genome,
and though establishing numerous grants to expand and accelerate the creation and
use of products used in personalized medicine. Given the slow creation and adoption
of products used for personalized medicine in clinical practice, the legislation estab-
lishes the Offi ce of Personalized Healthcare (OPH) to facilitate the coordinated
movement of genomics and personalized medicine throughout the Federal govern-
ment and private sector. The legislation also addresses several issues that have arisen
with the increased prevalence of genetic testing, including coverage and reimburse-
ment of personalized medicine products, and oversight of genetic tests (including
direct-to-consumer marketing). Given the recent issues surrounding direct-to-con-
sumer marketing of some genetic and genomic tests, the legislation would also direct
the FDA, FTC and CDC to evaluate these products that circumvent the both the
normal regulatory environment and patient-health care provider relationship.
On 20 January 2015, the President of USA announced a research initiative that
aims to accelerate progress toward a new era of personalized precision medicine
( http://www.whitehouse.gov/precisionmedicine ). The time is right for this initiative and
the NIH as well as other partners will work to achieve this vision (Collins and
Varmus 2015 ).
Department of Health and Human Services
and Personalized Medicine
In 2008, the Department of Health and Human Services (HHS) released an update
of its ongoing efforts in the personalized healthcare arena, and the vision the outgo-
ing US government had for this new medical area in diagnostics, treatment, and
research. The full 300-page report, Personalized Health Care: Pioneers, Partnerships,
Progress is available on line at: http://www.hhs.gov/myhealthcare/. In a prologue to
the report, meant as a note for the next government, it is explained that personaliz-
ing healthcare “is not a niche concern. Its promise is central to the future of health-
care.” However, a warning put an effective personalized healthcare system in place
as “the work of a generation.” According to the report, within 10 years “it will be
the norm for consumers and practitioners to anticipate that treatments should be
individually targeted, with diagnostics and therapies commonly associated as a
paired unit” and “within 15 years major clinical data sources can be securely linked
in a manner that gives most Americans the option of allowing their own de- identifi ed
health information to be employed in the quest for ever-more individualized under-
standing of health and disease.” It is further stated that “within 20 years data and
20 Development of Personalized Medicine