| JOIN OUR
LIST |
| | |
| Welcome to the August 2007
Friends of Cancer Research newsletter. To view the
entire edition online, please visit: http://www.focr.org/news/newsletter/recent.htm
|
FY
2008
APPROPRIATIONS
|
|
Approps
Bills Pass House, Await Action in
Senate
The
appropriations process continues as the House and Senate
consider the fiscal year (FY) 2008 appropriations bills.
In May, Congress passed a budget resolution setting
discretionary spending at $953.1 billion. In early June,
the House Appropriations Subcommittee on Labor, Health
and Human Services, and Education (LHHS) received an
allocation of $151.1 billion to divide among its diverse
programs, including the National Institutes of Health
(NIH) and National Cancer Institute (NCI). Later in
June, the full Senate Appropriations Committee passed
its $152 billion LHHS spending bill which included a 2.8
percent increase in funding for NIH in FY 2008. The full
House has now considered both the LHHS appropriations
bill and the Agriculture appropriations bill (which
includes funding for the FDA), while the full Senate has
yet to take action on either bill.
NIH
Appropriations
On July 11, the House
Appropriations Committee approved the FY 2008 LHHS
appropriations bill. The bill maintained the funding
levels previously determined by the LHHS Appropriations
Subcommittee, which included a 1.9 percent increase for
NIH. (See July's newsletter for more details.) The full
House of Representatives passed the measure by a vote of
276-140 on July 19.
In the Senate, the LHHS
appropriations bill passed the Senate Appropriations
Committee on June 21 and the bill has not progressed
since then. The Senate version of the bill contains a
2.8 percent increase for NIH. Congress is in recess from
August 6 until September 4, and the Senate is expected
to consider the bill when Congress returns to session in
September.
However, the
future of the appropriations bills remains uncertain.
The President has threatened to veto because they exceed
his spending cap by $23
billion.
FDA
Appropriations
The House Agriculture,
Rural Development, Food and Drug Administration, and
Related Agencies appropriations bill was approved by a
vote of 237-18 on August 2, amid displeasure from
Republican members over procedural motions pertaining to
the bill. The agriculture appropriations bill, which
funds the Food and Drug Administration (FDA), contains
$90.7 billion in funding for FY 2008, $18.8 billion of
which is reserved for discretionary spending with the
remainder going toward mandatory programs such as food
stamps and farm subsidies.
The House bill would
provide $1.69 billion for the FDA, an amount that is
$128.4 million above last year's FDA appropriation and
$62 million higher than the President's FY 2008 budget
request.
The overall House Agriculture
Appropriations bill exceeds the President's budget
request by almost $1 billion, therefore it may face a
veto threat from the President. Also included in the
bill is a contentious provision allowing prescription
drug reimportation from foreign countries, a provision
that the Administration strongly opposes.
The
Senate Agriculture Appropriations Committee passed its
version of the funding bill in July. The Senate's
request is $58 million above the House request and an
11% increase above the enacted 2007 budget. From this
increase, $17 million is proposed to go toward the FDA's
Critical Path Initiative to modernize product
development and evaluation. The full Senate is expected
to consider the bill after the August recess.
|
DRUG
SAFETY
|
|
|
PDUFA Reauthorization Takes
Recess
The reauthorization of the Prescription
Drug User Fee Act (PDUFA) has been a focus for the
biomedical community due to the critical role the
legislation plays in sustaining resources for the Food
and Drug Administration (FDA). Several months ago
Congress began initial negotiations on potential
components of an omnibus FDA bill that included PDUFA
with the intention of reauthorizing the legislation for
another 5-year period before the August recess. However,
just days before adjourning for recess, consideration of
PDUFA was put on hold.
Also included in the bill
are provisions that would bring enhancements to the
nation's drug safety system, reauthorization of the
Medical Device User Fee Modernization Act, and
reauthorization of two important pediatric research
bills.
Without reauthorization, PDUFA is set to
expire on September 30, 2007. Bill consideration was
initially expected prior to the August congressional
recess in order to avoid circulation of Reduction in
Force (RIF) notices to FDA employees warning them of the
looming deadline and subsequent loss of revenue. (RIF
notices are typically sent to agency employees within 60
days of an approaching funding deadline.) However,
Congress has pledged to pass the reauthorization to help
prevent the issuance of RIF notices. The FDA has also
stated its commitment to avoid layoff notices and
reportedly will utilize emergency reserve funds to
prevent such measures.
Both the House and the
Senate have passed versions of the FDA reauthorization
bill and negotiations have been underway to resolve the
differences for the past several weeks. Due to the large
number of other critical issues that required attention
prior to the August recess, PDUFA negotiators concluded
that in spite of their substantial progress they would
prefer not to rush decisions on this critical policy.
Senator Michael Enzi (R-WY), ranking member on the
Senate Health, Education, Labor, and Pension committee
voiced his disappointment that the bill was not
completed and the need for bipartisan support: "If we
are to answer to the American people, and give FDA the
necessary new authorities to better protect the public's
health and safety, we should not be politicizing this
process."
It is expected that negotiations on the
FDA legislation containing PDUFA will resume shortly
after Congress reconvenes in September.
|
IN CASE YOU
MISSED IT
|
|
|
The
following appeared in the news within the past
month.
"Lance hopes to grill presidential
candidates" MSNBC, July 21,
2007
"How to Get Fewer Scientists" By
Gene Sperling, Washington Post, July 24,
2007
"Small, vital gains over cancer" By
Michael V. Seiden, Philadelphia Inquirer, July
27, 2007
"Cancer Regression" By Richard
Miller, Wall Street Journal, August 1,
2007
"Burden of Proof: Cancer Drug Fails, So
Maker Tries New Pitch" By Greeta Anand, Wall
Street Journal, August 2,
2007
|
| FOCR
UPDATES |
|
|
New
Arrivals
Friends of Cancer Research is pleased to announce
the addition of a new staff
member.
Heidi Buchanan joins
Friends as Administrative Assistant. Heidi was most
recently a legislative coordinator with Stateside
Associates and previously held internships with Senator
Edward M. Kennedy and Senator Bernard
Sanders. | |
| |