Washington Highlights: September
8, 2006
ContentsPrior Issues  |
CMS Administrator to Step Down
The head of the Centers for Medicare and Medicaid Services (CMS),
Mark
B. McClellan, M.D., Ph.D., Sept. 5 announced he will resign
his post after a transition period in early October. In an email
to CMS employees, McClellan described his time at CMS as "one
of the most important and transformational times [the] agency has
ever experienced." Under his tenure as administrator, McClellan
oversaw the implementation of the Medicare Modernization Act, the
largest expansion of the program in its history.
Prior to his appointment to CMS in March 2004, McClellan served
as commissioner of the Food and Drug Administration (FDA) between
2002 and 2004. Prior to that, he held posts at the White House as
a member of the Council of Economic Advisers and as a senior health
policy aide. Before public service, he was an associate professor
of medicine at Stanford Medical School, and associate professor
of economics and director of the Program on Health Outcomes Research
at Stanford University. McClellan has indicated that he may return
to academia or join a think tank. His successor at CMS has not yet
been named.
NIH Seeks Comments on Genome-Wide
Association StudiesThe National Institutes of Health (NIH) Aug. 30 published
in the Federal
Register a request for information on its proposed policy for sharing
data obtained in NIH-supported genome-wide association studies (GWAS). The proposal
largely builds upon and extends existing policies for sharing data, research tools,
and other resources among grantees, and follows up on a May 15 announcement outlining
the agency's plans for public consultation relating to these studies, which identify
common genetic factors that may influence health and disease. "Whole
genome information," NIH notes, "when combined with clinical and other
phenotypic data, offers the potential for increased understanding of basic biological
processes affecting human health, improvement in the prediction of disease and
patient care, and ultimately the realization of the promise of personalized medicine."
The proposed policy establishes procedures for placing genetic and phenotypic
data in publicly accessible databases, for protecting individual privacy, and
for centrally tracking relevant applications and awards. On the question of intellectual
property, the agency expresses its "hope that genotype-phenotype associations
identified through NIH-supported and maintained GWAS datasets and their obvious
implications will remain available to all investigators, unencumbered by intellectual
property claims." The language is generally consistent both with the
previous NIH policies noted above and the recommendations of a recent National
Research Council panel on intellectual property in genomics and proteomics [see
Washington Highlights,
Nov. 18, 2005].
NIH encourages comments from the biomedical research
community, to be received by Oct. 31, 2006. Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
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