Washington Highlights: June 30,
2006
Contents
Prior Issues
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AAMC Comments on NIH Clinical and Translational
Science Awards
The AAMC June
28 sent a comment letter to the National Institutes of Health
(NIH) on the upcoming reissue of the Clinical and Translational
Science Award (CTSA) request for applications (RFA). While supportive
of the overall goals of the CTSA initiative, namely to strengthen
clinical and translational research by providing an "academic
home" for such research, AAMC made a number of suggestions
to improve and strengthen the RFA:
- Alter several parts of the language of the RFA to provide the flexibility
needed to accommodate the different organizational and administrative
mechanisms that characterize academic medicine, thus allowing diverse
institutions to meet the goals of the initiative;
- Provide financial support for the mentoring that is critical to the
success of the initiative; and
- Provide transparent and sufficient funding of this initiative in a
timely manner.
NIH is scheduled to reissue the RFA after Aug. 14, 2006, with applications
due Jan. 17, 2007.
Information:
Howard Dickler, Director
AAMC Biomedical Health Sciences Research
hdickler@aamc.org
(202) 828-0567
House Approves NSF Funding
The House June 29 approved the FY 2007 Science-State-Justice-Commerce
Appropriations bill (H.R.
5672), including $6.020 billion for the National Science Foundation
(NSF). The funding level represents a $439 million increase (8 percent)
over FY 2006, in accordance with the President's American Competitiveness
Initiative to double funding over 10 years for NSF, the National
Institute of Standards and Technology (NIST), and the Office of
Science at the Department of Energy. NIST also received the Administration's
request of $627 million, while the energy component was fully funded
at $4.132 billion in the House-passed FY 2007 Energy-Water Appropriations
bill (H.R.
5427).
Within the NSF appropriation is $4.6 billion for research, an increase
of $334.5 million over FY 2006, and $832.4 million for science education.
The Senate Appropriations Committee is scheduled to mark up the
spending bill July 13. The House is expected to consider two authorization
bills to enhance math and science competitiveness (H.R.
5356 and H.R.
5358) after the July 4 recess.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
Supreme Court Dismisses Diagnostic Tests Patent
Dispute
The Supreme Court June 22 dismissed as "improvidently granted"
its earlier decision to review a controversial patent case, LabCorp
v. Metabolite. The Court agreed with arguments by Metabolite and
the U.S. Solicitor General that the important question of law at
issue-what constitutes patentable subject matter under 35 U.S.C.
Section 101-had not been specifically examined by the lower courts
in this case.
The decision was a disappointment for the AAMC, which had joined
the American Medical Association (AMA) and other medical organizations
in an amicus brief filed in December 2005 asking that the patent
claim at issue be invalidated [see
Washington Highlights, Jan 6, 2006]. The patent, exclusively
licensed by Metabolite, claims a correlation, i.e., a thought process
that recognizes that elevated blood homocysteine levels may imply
a B-vitamin deficiency. The claim covers not only Metabolite's but
any other test that is used to measure blood homocysteine levels.
The AAMC argued that the correlation claimed in the patent is a
phenomenon or principle of nature, which should not be patentable
under section 101.
In a strong dissent from the majority's decision to dismiss the
case, Justice Stephen Breyer, joined by Justices John Paul Stevens
and David Souter, sided with the medical community and others, and
concluded that the patent claim is in fact invalid under current
patent law. Justice Breyer also elucidated the outstanding question
as to where boundaries lie between un-patentable principles of nature
and patentable processes or methods employing those principles.
Legal observers believe these boundaries will almost certainly need
to be revisited by the Court in the near future.
On a related matter, the U.S. Patent and Trademark Office is developing
new guidelines for patent examiners on patent subject matter eligibility.
The deadline for public comments on the interim guidelines is July
31.
Information:
Susan Ehringhaus, Sr. Director & Regulatory Counsel
AAMC Biomedical Health Sciences Research
sehringhaus@aamc.org
(202) 828-0543
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
CHAMPUS/TRICARE to Cover Clinical Trials
The Department of Defense June
20 announced in a final rule that the Civilian Health and Medical
Program of the Uniformed Services (CHAMPUS/TRICARE) will waive normal
requirements to allow beneficiaries to participate in Phase II and
Phase III clinical trials approved by the National Cancer Institute.
Coverage will not be available for Phase I trials or for any items
or services already covered under the investigational protocol.
A provider seeking treatment for a CHAMPUS-eligible patient must
obtain pre-authorization before initial evaluation. Applicable cost-shares
and deductibles will continue to apply.
The rule is effective July 20.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.orc
(202) 828-0490
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