Washington Highlights: June 9, 2006
Contents
Prior Issues
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House Subcommittee Passes HHS Funding Bill
The House Labor-HHS-Education Appropriations Subcommittee June
7 approved its FY 2007 spending bill by a party line vote of 9-7.
The bill provides $141.9 billion in discretionary funding, an increase
of $712 million (0.5 percent) over the comparable FY 2006 funding
level, and $4.136 billion more than proposed by the Bush Administration.
The bill provides $28.250 billion for the National Institutes of
Health (NIH), a decrease of $306,000 from the current year's level.
The House bill does not require NIH to transfer funds to the Global
HIV/AIDS initiative; thus, the bill does not include the $100 million
the Administration requested for that purpose. The bill includes
$6.1 billion for the Centers for Disease Control and Prevention
(CDC), a $27.5 million (0.5 percent) decrease below FY 2006.
The bill includes $163.6 million for Title VII health professions,
a 12.7 percent increase above FY 2006, and $150 million for Title
VIII nursing, which is level with the current year. The bill restores
the geriatric funding to the FY 2005 level of $31.5 million. However,
it eliminates the Health Careers Opportunity Program (HCOP) and
Faculty Loan Repayment Program, and provides level funding for the
Scholarships for Disadvantaged Students at $47 million and Centers
of Excellence at $11.9 million. Primary care medicine and dentistry
receives funding level with FY 2006 at $40.9 million. The Area Health
Education Centers (AHEC) and allied health programs also retain
last year's funding levels with FY 2006 at $28.7 million and $4
million, respectively. The public health, preventive medicine, and
dental public health programs, which were funded at $7.9 million
in last year's budget, are eliminated. Funding for rural interdisciplinary
training, workforce information analysis, health administration
traineeships, and the Health Education and Training Centers was
eliminated in the FY 2006 budget and is not restored in the subcommittee's
bill. The bill does not include previous years' rescissions of "unobligated
balance[s]" nor the President's proposed rescission of "the
Federal portion of the liquid assets" from the Title VII student
loan programs.
The bill rejects the cuts proposed in the President's budget for
Children's Hospitals Graduate Medical Education by providing $300
million for a 1 percent increase over FY 2006. It also includes
$131.5 million for National Health Service Corps, a $6 million (4.8
percent) increase. Additionally, the hospital bioterrorism preparedness
program receives $486.7 million, a 1.6 percent decrease below the
current funding. The Ryan White AIDS programs are allocated $2.1
billion for a $70 million (3.4 percent) increase.
The Agency for Healthcare Research and Quality (AHRQ) receives
$318.7 million, the same level of funding as in FY 2006, but the
bill provides the money via direct appropriations, rather than through
evaluation tap funds, which funded the agency last year. The Office
of the Secretary at HHS receives $79 million for international and
risk communication activities related to pandemic flu, as requested
in the President's budget.
The bill provides $106.7 million for the National Institute for
Disability and Rehabilitation Research within the Department of
Education, the same as the current year's level.
The bill also includes approximately $1 billion for earmarked projects
requested by Members of Congress, including $285 million for health
care-related facilities and activities under the Health Resources
and Services Administration. The FY 2006 Labor-HHS bill did not
include earmarked projects.
The House Appropriations Committee is tentatively scheduled to
consider the bill the week of June 12, and the bill is expected
to go to the House floor the week of June 19.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Erica Froyd, Director, Public Health and Research Legislative Affairs
AAMC Government Relations
efroyd@aamc.org
(202) 828-0525
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
AAMC Requests Delay of NRSA Tuition Cap
In a June 2 letter
to the National Institutes of Health (NIH), the AAMC and five other
higher education associations requested a delay in the implementation
of its proposed policy changes to the NIH Ruth L. Kirschstein National
Research Service Award (NRSA).
The NRSA program supports individual and institutional training
grants at the pre-doctoral and post-doctoral levels. The NIH is
proposing changes to its policies for funding tuition, fees, and
health insurance for these awards, arguing that these costs are
increasing at rates that are beyond NIH's fiscal capacity to sustain
(see Washington Highlights,
May 12).
The AAMC, the Association of American Universities, the Council
of Graduate Schools, the Council on Governmental Relations, and
the National Association of State Universities and Land Grant Colleges
requested that "NIH delay implementation of the proposed payment
cap of $16,000 on graduate tuition to allow more complete discussion
and analysis of alternatives with all stakeholders." The letter
states that, based on a preliminary analysis, "imposing a $16,000
cap would increase cost sharing by institutions by about 43%, to
nearly $100 million, and affect both public and private institutions;
for many, this shift will be difficult, if not impossible, to manage."
The NIH also proposes modifying the training related expenses category
for institutional training grants to include health insurance costs
as an allowable expense. The AAMC interpretation is that the NIH
will provide an additional fixed amount of funding in this single
category that can be used toward reimbursement of both health insurance
costs and training relating expenses. The associations are concerned
that this additional support may be "insufficient to cover
the costs of health insurance and would thereby require additional
support from the funds needed for other training related expenses."
The NIH plans to implement the new NIH policy with competing NRSA
awards issued in FY 2007.
Information:
Jodi Lubetsky, Staff Associate
AAMC Biomedical Health Sciences Research
jlubetsky@aamc.org
(202) 828-0485
AAMC Urges Congress to Save Health Professions
Programs
The AAMC June 1 sent a letter
to all Members of Congress urging their support for the restoration
of funding for the Title VII health professions programs to the
FY 2005 level of $300 million. The enacted FY 2006 budget cuts the
programs by 52 percent and eliminates programs essential to improving
the nation's health care workforce. The FY 2007 bill passed June
7 by the House Labor-HHS-Education Appropriations Subcommittee includes
an $18 million increase above the FY 2006 level, bringing the programs
to $164 million (see related story).
The letter, signed by 132 AAMC member institutions, states that
Title VII programs "provide vital support to the nation's medical
schools and teaching hospitals for the recruitment, education and
training of a unique group of physicians and other health professionals,
who are more likely to provide care in rural and other underserved
areas." It highlights the drastic cuts to vital programs funded
through Title VII that recruit and mentor minority students, such
as the Centers of Excellence and Health Careers Opportunity Programs,
and points out that the 54 percent cut to primary care programs
hampers efforts to train primary care providers needed across the
country.
The letter closes by stating that restoring $300 million to the
Title VII programs "will have enormous impact as AAMC members
and our fellow health professions educators strive to provide the
nation a well-trained, diverse health care workforce."
Information:
Erica Froyd, Director, Public Health and Research Legislative Affairs
AAMC Government Relations
efroyd@aamc.org
(202) 828-0525
Zerhouni Discusses NIH Grants With Advisory Committee
National Institutes of Health (NIH) Director Elias Zerhouni, M.D.,
June 2 analyzed fiscal constraints facing NIH in the current 2006
budget and the factors lowering success rates for research project
grant applications at the meeting of the Advisory Committee to the
Director (ACD). Describing NIH as facing a "perfect storm"
in the federal budget-deficits, military and security expenditures,
Katrina response, and other urgencies-Dr. Zerhouni noted that the
NIH budget has remained relatively flat (or declined, when adjusted
for inflation) since the completion of the 5-year budget doubling
in 2003.
He noted that during this period, applications for new grants have
increased by more than 8,359, slightly more than the increase in
new grant applications during the period of the NIH doubling. Moreover,
NIH must continue to meet its obligations for funding the large
number of ongoing research projects initiated during the doubling.
Dr. Zerhouni contested several "myths" about factors further
depressing funding opportunities for traditional NIH investigators,
stating that NIH is not apportioning a larger share of funds for
applied or directed research. He also emphasized that the NIH Roadmap,
which is 0.8 percent of the budget and largely supports research
grants, is not a significant factor contributing to lower success
rates.
The ACD strongly supported Dr. Zerhouni's strategy for improving
the agency's efforts to communicate the benefits of NIH supported
research to the public. John Burklow, NIH Associate Director for
Communications and Public Liaison, presented a detailed communications
plan, which will emphasize that relatively small per capita expenditures
on NIH research have led to significant reductions in mortality
from coronary artery disease, increased survival rates for cancer
patients, or new treatments for Parkinson's disease, among other
benefits.
Slides from the presentation to the ACD have not yet been posted
on the NIH website, but Dr. Zerhouni made similar remarks
to the AAMC's Advisory Panel on Research on May 24.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
House Panel Examines VA Research Program
The House Committee on Veterans Affairs June 7 held an oversight
hearing,
entitled "From Bench to Bedside," to review the Department
of Veterans Affairs (VA) Medical and Prosthetic Research program.
Chairman Steve Buyer (R-Ind.) praised the VA's genomic medicine
program that links patient's genetic information with the VA's existing
electronic health records. Rep. Vic Snyder (D-Ark.) and Rep. Ginny
Brown-Waite (R-Fla.) questioned the VA's ability to retain and recruit
physicians without adequate funding for VA research. Rep. Snyder
also suggested funding the agency at a level at least equal to biomedical
inflation and questioned the VA's optimism in leveraging non-VA
funds, especially when NIH is proposed for level funding in FY 2007.
Jonathan B. Perlin, M.D., Ph.D., Under Secretary for Health, and
Joel Kupersmith, M.D., Chief Research and Development Officer, testified
on behalf of the VA. On the second panel, Dennis E. Niewoehner,
M.D., Chief, Pulmonary Section, VA Medical Center Minneapolis, Minn.,
testified on behalf of Friends of VA Medical Care and Health Research
(FOVA). Dr. Niewoehner stressed the need for additional funding
to upgrade VA medical research facilities and recommended $45 million
for these purposes. The House provided $12 million for the VA minor
construction budget to upgrade these facilities in the FY 2007 VA
appropriations bill.
Carl Blake, Senior Associate Legislative Director, Paralyzed Veterans
of America, and Rick Weidman, Executive Director, Policy and Government
Affairs, Vietnam Veterans of America, also presented testimony.
Informtion:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
House Committee Approves Competitiveness Bills
The House Science Committee June 7 unanimously approved a set of
bills promoting U.S. competitiveness through math and science research
and education. The "Research for Competitiveness Act"
(H.R.
5356) builds upon existing programs at the National Science
Foundation (NSF) by awarding grants to early career researchers,
and establishes a parallel program at the Department of Energy.
The committee agreed by voice vote to incorporate within H.R. 5356
a similar bill (H.R.
5357) that provides grants (expected to be matched by industry)
to researchers conducting "high-risk, high-return fundamental
research" at the NSF and Department of Energy.
A separate bill (H.R.
5358) addresses improved math and science education through
programs at the NSF. That measure offers grants to institutions
of higher education to enhance undergraduate education in science,
technology, engineering, and mathematics, and offers tuition support
to math and science majors in exchange for a teaching commitment.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
Federal Court Again Takes Up Research Exemption
Case
The Court of Appeals for the Federal Circuit (CAFC) June 5 again
heard arguments about the scope and reach of a statutory research
exemption from patent infringement. While not involving an academic
organization directly, the case could have implications for research
and technology transfer at universities and especially medical schools.
In the 1990s, the German firm Merck KGaA (unconnected with the U.S.
drug company) supported research at Scripps Institute on a peptide
used to inhibit angiogenesis, or the growth of blood vessels in
tissue, a potentially useful approach to restrict tumor growth.
Integra Life Sciences, which owns patents on the peptide, won an
infringement suit against Merck in District Court, a decision later
upheld by the CAFC. However, Merck appealed to the U.S. Supreme
Court, which last summer ruled that the lower courts too narrowly
restricted the application of the statutory research exemption under
section 271(e) of the patent code. That exemption, enacted as part
of the Hatch-Waxman Act in 1984, provides a safe-harbor for conducting
necessary experimentation related to regulatory approval for new
or generic drugs.
The Supreme Court remanded the case to the CAFC, leading to the
June 5 hearing. Judge Pauline Newman, the chief judge on the three-member
panel, probed Merck's counsel about the reach of the statutory research
exemption, questioning whether the Supreme Court established any
bright line for when the exemption applies in the often lengthy
process of drug development. Judge Randall Rader, who had written
the majority opinion overruled by the high court, focused on the
use of Integra's patents as "research tools"; e.g., methods
or compounds used primarily to further laboratory research. He questioned
whether the Supreme Court decision had any effect on research tools
(that decision pointedly noted that research tools had not been
raised in the trial record). Judge Rader underscored the possibility
that the case could be remanded to the district court for a jury
trial to consider new evidence on this question. A decision of the
CAFC is expected later this summer.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
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