Washington Highlights: August 10,
2007
Contents
Prior Issues
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Fate of FY 2008 Spending Bills Uncertain
When Congress returns to Washington on Sept. 4, it will once again
face the annual task of trying to complete the appropriations bills
prior to the Oct. 1 start of the federal fiscal year. And as in
the past several years, it will likely fail, resulting in the need
for one or more continuing resolutions (CRs) to keep the government
running past Sept. 30.
The House has passed all 12 of the FY 2008 appropriations bills,
approving the defense spending bill (H.R.
3222) in the early morning hours of Aug. 5 prior to leaving
town. In contrast, the Senate has passed only one appropriations
bill: Homeland Security (S.
1644).
As its first order of business in September, the Senate will take
up the Military Construction/Veterans Affairs bill (H.R.
2642). However, faced with the need to consider another supplemental
spending bill for the war and the review of the Administration's
report on conditions in Iraq in mid-September, in addition to conference
agreements on SCHIP and FDA user fee reauthorizations, it is not
clear how much time the Senate will have to devote to considering
other appropriations bills.
Further complicating the situation, the White House has issued
Statements of Administration Policy opposing seven of the spending
bills because they include "an irresponsible and excessive
level of spending." The targeted measures include the Labor-HHS-Education
bill (H.R.
3043) bill passed by the House July 19. Congress has added nearly
$23 billion to the Administration's request for discretionary spending
in FY 2008.
The veto threats have led to speculation that the Democratic leadership
in Congress may bundle a numbers of the appropriations bills into
an omnibus package with the defense spending bill.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
AAMC Offers Feedback on Bayh-Dole
The AAMC and three other academic associations Aug. 8 sent a letter
to leaders of the House Science and Technology Subcommittee on Technology
and Innovation, affirming support for the federal Bayh-Dole Act
(P.L. 96-517) and its continued use as a tool for fostering economic
and scientific progress. The letter states that the Bayh-Dole Act
has made a "substantial contribution to U.S. economic growth
and competitiveness over the past 25 years," but several issues
must be addressed in any discussions of academic collaborations
with industry, including freedom to publish, sustaining conducive
training environments, conflict-of-interest management, and generally
safeguarding an institution's academic mission.
The subcommittee held a hearing on the future of Bayh-Dole on July
17 [see Washington
Highlights,
July 20]. Subcommittee chair David Wu (D-Ore.) has said that
the subcommittee also plans to hold a hearing on the Stevenson-Wylder
Act (P.L. 96-480), which regulates federal laboratory collaborations
with industry.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
Savings Proposal Introduced to Benefit NIH
Reps. Steve Pearce (R-N.M.), Emanuel Cleaver (D-Mo.), and Dan Burton
(R-Ill.) Aug. 3 introduced the "Americans Saving through Health
Research Bonds Act of 2007" (H.R.
3434). The bill would establish a new series of U.S. savings
bonds for individuals that would direct a small portion of the return
on the bond to the National Institutes of Health (NIH) to fund medical
research. When an individual redeems a Health Research Bond, rather
than taxing the interest earned, 10 percent would be sent to the
NIH institute of the person's choice. Introducing the bill, Rep.
Pearce noted in FY 2006, the Treasury Department redeemed $14.5
billion in bonds, of which $7.9 billion was payments on interest.
Rep. Pearce estimates if 20 percent of those had been Health Research
Bonds, $158 million would have been generated for NIH.
The AAMC has endorsed
this bill. H.R. 3434 has been referred to the House Ways and Means
Committee.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Senators Introduce Patient Privacy Bill
Senators Patrick Leahy (D-Vt.) and Edward Kennedy (D-Mass.) July
18 introduced the "Health Information Privacy and Security
Act" (S.
1814), that they describe as creating "new privacy safeguards
to better protect American's health information in the Information
Age." If enacted, the bill would make major changes to current
privacy requirements under the "Health Insurance Portability
and Accountability Act of 1996" (HIPAA, P.L.
104-191) and would supersede those requirements to the extent
that the bill conflicts with HIPAA. Many of the provisions in the
bill were discussed during the HIPAA privacy debates and were rejected
as imposing serious impediments to the operation of the health care
system and barriers to health researchers.
The bill adds a definition, "informed consent" to mean
the "authorization for use or disclosure of protected health
information by the individual who is the subject of the information,
conditioned upon the individual's having been informed of the nature
and probability of harm to the individual resulting from such authorization."
An authorization would be required for disclosure for treatment
or payment purposes, something not required under HIPAA. The bill
also calls on the Secretary of Health and Human Services to prepare
and submit to Congress recommendations about whether written informed
consent should be required before protected health information can
be used for health research.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.orc
(202) 828-0490
Federal Court Upholds Broad Research Exemption
in Drug Development
The Court of Appeals for the Federal Circuit (CAFC) July 27 released
its decision
in Integra v. Merck KGaA on the application of a statutory
exemption from patent infringement in biomedical research. The CAFC
found for the defendants, Merck KGaA (a German firm unconnected
to the U.S. company) and Scripps Research Institute.
In 2001, the U.S. District Court for Southern California ruled
that Merck and Scripps had infringed patents on several peptides
held by Integra in the course of their research on mechanisms of
angiogenesis. In 2003, the CAFC upheld the lower court's finding
of infringement, but two years later, the Supreme Court reversed
the decision and returned the case to the Federal Circuit, where
it was reheard on June 5, 2006 [see Washington
Highlights, June 9, 2006]. The reversal centered on a statutory
exemption from patent infringement [U.S.C sec. 271(e)(1)] permitted
for research in drug development required to generate information
for Food and Drug Administration (FDA) approval. That statutory
exemption, or "safe harbor," was a key part of the 1984
Hatch-Waxman Act intended to facilitate approval and manufacture
of generic versions of patented drugs as soon as their patent terms
expired.
As expected, the three-judge panel for the CAFC reversed the district
court ruling, finding that the experiments sponsored by Merck and
conducted by Scripps were protected under an exemption as circumscribed
by the Supreme Court. Chief Judge Pauline Newman, whose dissent
in the original ruling later prevailed in the Supreme Court, wrote
for the new majority: "Of particular significance…is the
[Supreme] Court's ruling that the FDA Exemption includes experimentation
on products that are not ultimately the subject of an FDA submission,
provided that the particular biological process and physiological
effect had been identified and the work was reasonably related to
that appropriate for inclusion in an IND [investigational new drug]
application."
It remains unclear how far "back" research might be determined
to reasonably relate to preparation for submission to the FDA. Also
to be resolved, the Supreme Court's 2005 ruling sidestepped a controversial
issue of how the statutory research exemption affects so-called
research tools (i.e., materials primarily used in laboratory research,
not themselves intended for eventual use as drugs). Judge Randall
Rader dissented in part from the recent ruling, arguing that the
majority had inappropriately extended the exemption to research
tools beyond what the Supreme Court determined. The full effect
of the ruling and the resolution of the controversy about enforcement
of patents on research tools in biomedical research have yet to
be determined.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
HHS Seeks Comments on AHIC Transition
The Department of Health and Human Services (HHS) Office of the
National Coordinator for Health Information Technology Aug. 6 issued
a draft
white paper outlining a strategy for implementing a successor
to America's Health Information Community (AHIC). Under its 2005
charter, AHIC will transition to "an independent and sustainable
public-private partnership" by fall 2008. The public may comment
on the white paper's proposals by Sept. 10.
Information:
Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
President Signs Competitiveness Measure
The President Aug. 9 signed into law the "America COMPETES
Act" (H.R.
2272), which seeks to improve national competitiveness by enhancing
research and education in math and the physical sciences. The House
and the Senate each had approved the measure on Aug. 2 with bipartisan
support [see Washington
Highlights,
Aug. 3].
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
HHS Assistant Secretary for Health Resigns
Secretary of Health and Human Services Mike Leavitt Aug. 7 announced
the resignation of Assistant Secretary for Health John Agwunobi,
M.D., M.B.A., M.P.H, effective Sept. 4, 2007. Dr. Agwunobi, a pediatrician,
has served at HHS since Dec. 2005, prior to which he served as Florida's
Secretary of Health. He has been named Senior Vice President and
President for the Professional Services Division for Wal-Mart, where
he will oversee the company's health and wellness business unit,
including pharmacies, vision centers, and health care clinics.
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