Washington Highlights: February
22, 2008
Contents
Prior Issues
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AAMC, Health Organizations Urge Increased FY 2009
Health Funding
The AAMC joined over 440 organizations in a Feb. 19 letter
to Congress urging increased funding for all federal public health
activities and programs. The coalition recommends a $5.3 billion
increase in the FY 2009 discretionary funds allocated for health.
The letter cautions that the President's budget for FY 2009 continues
to underfund and undermine these important initiatives. The letter
notes that the recommended increase will:
- restore funding to public health programs cut in FY 2006;
- restore lost purchasing power that flat-funding for at least
five years has eroded; and
- provide investments that begin to truly meet health challenges
facing the nation.
Information:
Dave Moore, Senior Associate Vice President
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
NIH Advisory Committee Proposes Major Changes
in NIH Peer Review System
The Working Group on Peer Review of the NIH Advisory Committee
to the Director (ACD) Feb. 21 presented draft recommendations
for enhancing the NIH peer review system to the full ACD. The ACD
accepted the working group's recommendations and will present a
written report to NIH Director Elias Zerhouni, M.D., on Feb. 29.
Dr. Zerhouni announced that he will form an implementation team
and report back to the ACD in 4-6 weeks on implementation details
and timelines.
The working group's recommendations follow extensive consultation
with stakeholder communities, including the extramural community,
advocacy groups, professional societies, and NIH staff, to collect
input and ideas. The panel was co-chaired by Keith Yamamoto, Ph.D.,
Executive Vice Dean, University of California San Fransisco School
of Medicine, and Lawrence Tabak, D.D.S., Ph.D., Director, National
Institute of Dental and Craniofacial Research.
Among the most controversial of the Working Group's proposals is
a minimum percent effort on NIH-funded research project grants.
Principal Investigators (PIs) would be required to devote at least
20 percent effort, unless they can provide an explicit justification
to the relevant institute or center (IC) for a lower percent effort.
Other recommendations include allowing peer review groups to provide
a "not recommended for resubmission" decision option,
providing ratings for all applications, and eliminating amended
application status by considering all applications as being "new."
The group also urged a revision to the peer review rating system
so that it focuses on impact, investigator(s), innovation, plan,
and environment (including information on institutional support
for the applicant). To support new investigators, the working group
recommended that NIH:
- continue to fund more R01 grants for early career investigators;
- consider the merits of reviewing early career investigators
separately to enhance innovation and risk-taking by applicants;
and
- consider the merits of ranking early career investigators
against each other.
The working group urged NIH to examine salary support for PIs,
"recognizing the diversity of business models employed by applicant
organizations." The panel also urged NIH to analyze its contribution
to the optimal biomedical workforce by evaluating the total number
of graduate students and postdoctoral fellows being supported, and
to develop a census of research associates/staff scientists as an
initial step towards exploring approaches to providing more stable
support for these individuals.
Information:
Tony Mazzaschi, Senior Associate Vice President
AAMC Biomedical Health Sciences Research
tmazzaschi@aamc.org
(202) 828-0059
FDA Issues "Good Reprint Practices" Draft Guidance
The Food and Drug Administration (FDA) Feb. 15 issued draft guidance
on "Good Reprint Practices" for industry use in the distribution
of medical or scientific journal articles and reference publications
that involve unapproved uses of FDA-approved drugs and medical devices.
The FDA's "Good Reprint Practices" draft guidance recommends
principles manufacturers should follow when they distribute scientific
or medical journal reprints, articles, or reference publications.
Some of the principles include ensuring that the article or reference
be published by an organization that has an editorial board. The
organization also should fully disclose any conflicts of interest
or biases for all authors, contributors or editors associated with
the journal article. In addition, the draft guidance discourages
distribution of special supplements or publications that have been
funded by one or more of the manufacturers of the product in the
article.
The FDA retains legal authority to determine whether distribution
of an article or publication constitutes promotion of an unapproved
"new use," or whether such activities cause a product
to be considered misbranded or adulterated under the Federal Food,
Drug and Cosmetic Act.
Public comments should be submitted within 60 days of the Feb.
20 Federal Register notice
announcing the availability of the draft guidance.
Information:
Irena Tartakovsky, Clinical Research Program Manager
AAMC Division of Biomedical and Health Sciences Research
itartakovsky@aamc.org
(202) 862-6134
On the Hill...
Rep. John Shadegg (R-Ariz.) Feb. 21 reversed his decision not to
run for reelection in response to a letter signed by 146 of his
colleagues in the House and a second letter signed by the leaders
of 33 different conservative organizations. Shadegg had announced
his retirement Feb. 11.
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