Washington Highlights: February
16, 2007
Bush Signs
FY 2007 Funding Resolution
Contents
Prior
Issues
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President Bush Feb. 15 signed a $463.5 billion
spending package to fund much of the federal government for the remainder of FY
2007. The Senate Feb. 14 passed the FY 2007 Joint Funding resolution (H.J.Res.
20) by a vote of 81-15, with 15 Republicans voting against the measure. The
House approved H.J.Res. 20 on Jan. 31.
The Joint Funding resolution provides
$28.9 billion for NIH in FY 2007, an increase of $620 million (2.2 percent) over
FY 2006. VA Research receives $413.7 million, an increase of $1.7 million (0.4
percent) over FY 2006. The measure also provides $185 million for the Title VII
health professions programs, an increase of $40 million (27.6 percent) over FY
2006. The additional Title VII funds include $32 million to restore the geriatrics
training programs to the FY 2005 level and an $8 million increase for primary
care programs.
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
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
VA Committees Examine FY 2008
Budget
The Senate
Committee on Veterans Affairs Feb. 13 and House
VA Subcommittee on Health Feb. 14 held hearings to examine the President's
proposed FY 2008 budget for the Department of Veterans Affairs (VA). VA Secretary
James Nicholson and VA Acting Undersecretary for Health Michael Kussman, M.D.
presented the Administration's testimony at the Senate and House hearings, respectively.
The Senate hearing addressed a broad range of veterans issues, but Chairman
Daniel Akaka (D-Hawaii) took a moment in his opening statement to focus on the
VA Research program. He stated, "It is also shortsighted to cut research,
as the proposed budget does. Many physicians choose to work at VA because of the
opportunity to do research. I truly believe that we need to be adding to this
account and not cutting it. Imperiling the research program hurts VA's ability
to recruit and retain excellent physician researchers and could therefore adversely
impact the quality of overall health care." Sens. Patty Murray (D-Wash.)
and Bernard Sanders (I-Vt.) echoed these remarks. The President's budget proposes
$411 million for VA Medical and Prosthetic Research, $2.7 million less than the
FY 2007 Joint Funding resolution (see related story).
The
House VA Subcommittee on Health focused on spending within the Veterans Health
Administration. Reps. Vic Snyder (D-Ark.) and Ken Salazar (D-Colo.) questioned
why the Administration has requested a cut for VA Medical and Prosthetic Research.
Gary Ewart, Director of Government Relations at the American Thoracic Society,
testified on behalf of the Friends of VA Medical Care and Health Research (FOVA).
For FY 2008 FOVA recommends $480 million for VA Research and an additional $45 million for renovating
existing research facilities. Additionally, Mr. Ewart urged the committee to preserve
the integrity of VA's intramural, peer-review system by excluding earmarks or
designations of funds for specific types of research.
Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
Enzi, Kennedy Reintroduce
Drug Safety Bill, Call for Reporting of Clinical Trial Results
A provision
in a major drug safety bill introduced by Senators Mike Enzi (R-Wyo.) and Edward
Kennedy (D-Mass.) would require that the results of all Phase III and Phase IV
clinical trials be made available in a publicly available database. Senators Enzi
and Kennedy, the ranking member and chair, respectively, of the Senate Health,
Education, Labor, and Pensions (HELP) Committee, re-introduced the "Enhancing
Drug Safety and Innovation Act" (S. 484) on Feb. 1. First introduced in August
of 2006, the bill would require drug makers and the Food and Drug Administration
(FDA) to engage in better safety planning before a drug is approved for release
to the public while improving the FDA's response to risks identified after a drug
is on the market.
The centerpiece of the bill is the mandate that drugs
and biologics be approved with risk evaluation and mitigation strategies (REMS),
which would specify requirements for issues such as drug labeling, adverse event
reporting, post-approval assessments, and direct to consumer advertising. The
bill also provides for a structured dispute resolution process should disagreements
arise between FDA and the drug sponsor.
S. 484 creates a clinical trials
registry and the results database. Clinical trials of late Phase II, Phase III
and Phase IV would be required to register in a publicly available database. The
required data elements would be based on the World Health Organization international
consensus data set. All Phase III and Phase IV trials would be required to deposit
their results in a publicly available database. There would be a process to determine
whether and when to add those Phase II trials that had to register. Several items
of information would be placed in fields in the database entry, while the bulk
of the information describing the results would be in two summary documents for
lay and technical audiences. Results could be submitted to the database but not
made publicly available pending regulatory action and/or publication. A proposal
to create a clinical trials database also was re-introduced as a free-standing
bill (S.
467) by Senator Chris Dodd (D-Conn.) and five cosponsors on Jan. 31.
S.
484 also establishes a non-profit institute - the Reagan-Udall Institute for Applied
Biomedical Research - to lead collaborations among the FDA, academic research
institutions, and industry directed to improving the process of drug, device,
and biologic development and evaluation. The institute would be funded by both
industry and the government, similar to the National Institutes of Health foundation.
The
bill also requires public disclosure of waivers of conflicts of interest of advisory
committee members before advisory committee meetings, and greater efforts by FDA
to identify qualified advisory committee members with minimal conflicts.
A
statement issued by Senator Kennedy's office says that he and Senator Enzi hope
to report out a bill addressing the drug user fee reauthorization, drug safety,
and three other FDA reauthorizations shortly after Easter, for consideration on
the Senate floor by late spring, and a conference with the House with final passage
before the August recess.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Kennedy
Introduces Student Loan Oversight Bill
Sen. Edward Kennedy (D-Mass.) Feb.
1, with Sen. Richard Durbin (D-Ill.), introduced the "Student
Loan Sunshine Act" (S.
486) intended to "protect students and parents from exploitation by private
lenders and lenders who offer gifts to colleges as a way to secure loan business."
The Sunshine Act requires full disclosure and explanation of special arrangements
that lenders and colleges have to offer loan products at the college; bans lenders
from offering gifts over $10 to college employees; requires preferred lender lists
to have at least three non-affiliated lenders; and encourages borrowers to participate
in the government's loan programs before taking out private loans.
Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
House Panel Approves Genetics
Bill
The House Education and Labor Committee Feb. 14 approved the Genetics
Information Nondiscrimination Act (H.R.
493). Similar bills have passed the Senate in 2003 and 2005.
The legislation forbids health insurers and employers from requiring
individuals to submit to genetic testing, or from using genetic
information to make insurance or employment decisions. The Senate
Health, Education, Labor and Pensions Committee Jan. 31 approved
its version of the bill [see Washington
Highlights, Feb. 2].
The bill has
also been referred to House Ways and Means and Energy and Commerce Committees.
Information:
Erica Froyd, Director, Public Health and Research Legislative Affairs
AAMC Government Relations
efroyd@aamc.org
(202) 828-0525
Norwood Succumbs to Cancer
Rep.
Charlie Norwood (R-Ga.), a dentist, passed away Feb. 13 following an extended
battle with cancer. Rep. Norwood was first elected to the House in 1994. A member
of the Energy and Commerce Committee, he was perhaps best known for sponsoring
a "patients' bill of rights" to strengthen the hand of individuals enrolled
in managed care plans. Rep. Norwood was a strong supporter of the Title VII health
professions programs. Each year since 2003, he, along with Rep. Diana DeGette
(D-Colo.), led a bipartisan Congressional sign-on letter urging appropriators
to fully fund the Title VII programs. The 2006 version of the letter garnered
190 signers.
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