Crawford Nomination Hearing Announced by HELP
Committee
The Senate Health, Education, Labor, Pensions (HELP)
Committee announced it will hold a March 17 hearing on
the nomination of Dr. Lester Crawford to be commissioner of FDA.
To date, there have been no expressions of serious concern about Crawford
assuming the FDA leadership, although there are certain to be questions
raised at the hearing regarding contentious matters that
have confronted the agency over the last several years.
For example,
FDA has been one of the key agencies responsible for implementing
food-security provisions of the Bioshield Act and has received substantial
additional appropriations for compliance and enforcement activities
related to the security of the food supply. Discussions about updating
that legislation are ongoing; many changes would be in
the purview of the HELP Committee. Crawford has headed up FDA’s
implementation of Bioshield programs, both in his earlier capacity
as deputy commissioner and his current role as acting commissioner.
Another key issue facing FDA
is vaccine supply. The flu vaccine “shortage” of last year
created a firestorm of criticism on Capitol Hill, much of it directed
at FDA.
It is likely
that Crawford will be asked what actions have been taken and what
plans the agency has to improve the situation for the future.
Drug safety also is highly likely to be a focus of
questions. Sen. Chuck Grassley (R-IA) has indicated
he intends
to hold up the nomination of Crawford unless he receives some assurances
from him about FDA actions to improve drug safety. Although
Grassley is not a member of the HELP Committee, his concerns
are almost certain to be raised. Specifically, Grassley has
stated as recently as yesterday that he remains concerned that significant
drug safety issues occurred on Crawford’s watch and
FDA still has not provided his Finance Committee investigations staff
with all the documents they requested. Grassley continues to
believe that FDA needs a “major overhaul” to
do a better job in the drug safety arena; he seems to want a commitment
from Crawford that major changes will be made. Among the particular
changes Grassley advocates is the establishment of an “independent” drug
safety function at FDA, separate from the Center for Drug Evaluation
Research and reporting directly to the FDA Commissioner.
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House and Senate Committees Complete Work
on Budget Resolutions
In both the House and Senate, committee action on
the budget resolution's complete and the resolutions are
expected to be considered
by the full House and Senate next week. In both House and Senate committees,
the resolutions passed by party-line votes. Further discussion about
concerns, especially on the part of Democratic members, can be expected
when the resolutions reach the floors of both chambers.
In the health area, Medicare and Medicaid spending
and savings are on the front burner in both resolutions. In the House,
the budget proposal
would instruct the Energy Commerce and Ways and Means Committees
to produce program savings
of $20 billion and $18.7 billion respectively. The Energy Commerce
Committee
has jurisdiction over Medicaid and some (Part B) of Medicare, in addition
to a number of discretionary health programs. The expectation is
a large portion of the savings from that Committee would come from
Medicaid spending reductions, although reductions are also possible
in other programs. In the case of the Ways and Means Committee, multiple
additional possible sources of savings exist, but certainly a large
portion could come from the Medicare program.
As to Medicaid specifically, both the House and Senate
committees engaged in discussions of the importance of saving money
from waste,
fraud, and abuse in this program. Members who supported
the budget resolutions stated Medicaid reform is needed
and a could save a great deal of money. They also noted
further discussions of precisely how
savings would
be achieved in Medicaid would occur between Congress and the states,
with the governors, members stated, expected to produce ideas of their
own for achieving savings.
In contrast to the significant health program-related
savings anticipated in the House resolution, the Senate resolution
calls for
much more modest savings. The Finance Committee (with jurisdiction
over both Medicaid and Medicare) is directed to produce savings of
approximately $15 billion and the Health, Education, Labor Pensions
(HELP) Committee (which has jurisdiction over a number of discretionary
health programs as well as education and other programs)is expected
to save approximately $8.6 billion.
In response to questions regarding where the Finance
Committee would look for savings, Chairman Chuck Grassley (R-IA) stated
all the
savings would be found in the Medicaid program spending and Medicare
would not be in play. (About whether Medicare would be a significant
source of savings, House Ways and Means health subcommittee Chair Rep.
Nancy Johnson (R-CT) agreed with Grassley.). As to wasteful spending
in Medicaid, Senate Budget Committee Chair Judd Gregg (R-NH) stated
some states are receiving “inappropriately” as much
as $6 billion annually in Medicaid payments.
Among the amendments offered during committee mark-ups,
similar “non-interference” repeals
offered in both House and Senate Committees were defeated in both cases.
These amendments would have directed a repeal of the provision in
the Medicare Modernization Act preventing the Secretary of Health
and Human Services from interfering in negotiations between pharmaceutical
companies and companies offering Medicare Part D drug benefit plans.
In the Senate Budget Committee, an amendment by Sen.
Mike Enzi (R-WY), chair of the HELP Committee, regarding the importation
of
prescription drugs was accepted. Enzi’s proposal is to
create a reserve fund for safe importation legislation, if such legislation
were to be reported from the HELP Committee.
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Senate Committee Reports Contact Lens,
Drug Safety Legislation
On March 9, the Senate Committee on Health, Education,
Labor, Pensions (HELP) reported S.172, to address the regulation
of non-prescription contact lenses, and S.544, the Patient Safety
and Quality Improvement Act. The bills passed from the committee with
no objection and are expected to be considered shortly by the full
Senate.
S.172, introduced by Sen.s Mike DeWine (R-OH) and
Ted Kennedy (D-MA), like its counterpart H.R. 371 by Reps.
John Boozman (R-AR) and Henry Waxman (D-CA) would amend the Food,
Drug, Cosmetic Act to provide all contact lenses be
regulated as medical devices. The bill addresses a concern that various
non-prescription contact lenses, intended for a purely
cosmetic
purpose, are being marketed broadly, resulting in many cases of
serious eye injury. Often these kinds of lenses are purchased without
any consultation with a qualified eye care professional. To date, FDA
has stated it cannot regulate as a medical device a product that
does not fit the definition of device in the statute, namely the
product has a purpose to diagnose, prevent, or treat a disease or
other health-related condition.
S.544, introduced by Sen. Jim Jeffords (I-VT) and
six bipartisan colleagues (including Senate majority leader Sen.
Bill Frist (R-TN)
and HELP Committee Chair Sen. Mike Enzi (R-WY)), is essentially
a re-introduction of legislation from the 108th Congress that passed
both House and Senate but failed in conference committee.
The legislation is intended to establish and support a variety of steps
to reduce medical errors. It does this by providing
some legal protections for health care providers who report patient
errors and creating incentives for such reporting; establishing Patient
Safety Organizations to triage, catalog, and maintain the confidentiality
of medical error reports while also making known to health care providers
and consumers what errors occur and how they occur, to help prevent
them in the future; and encouraging the establishment of national standards
for the integration of information systems.
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President Bush Presses Japan
Prime Minister Koizumi on Beef Trade
In a rare show of presidential arm twisting, President Bush this week
put pressure on Japanese Prime Minister Junichiro Koizumi to resume
beef trade with the U.S. during a 15-minute phone conversation covering
a number of international issues. Secretary of State Condoleezza Rice
is also expected to press the beef trade issue during a visit to Japan
later this month to talk with her counterparts.
Koizumi said he wants to resume beef trade soon, but said his government
must first wait until its Food Safety Commission finishes its review
of an agreement reached between the two governments earlier this month
to allow U.S. Grade A40 beef from animals less than 21 months of age
to enter Japan without BSE testing. Reports indicated the commission
is close to an agreement on the system, but final action will wait
for a commission meeting later this month.
Japan has also said it will take some time for it to rewrite and reconcile
its domestic food safety and import regulations to reflect any agreement
to resume trade.
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Judge Rejects Meatpacker Suit on Canadian Meat Trade
A move by U.S. meatpacking companies to have USDA
to lift all restrictions on beef and beef product trade with Canada
was
rejected early this
week by a federal judge, the latest setback to normalizing trade with
Canada.
The American Meat Institute (AMI) sought to have
USDA broaden its original rulemaking allowing live animals under
30 months of age
and their products to enter the U.S. to include animals and meat from
animals over 30 months of age under certain conditions.
AMI, expressing
disappointment in the judge’s ruling, said, “The U.S. meat
industry continues to believe as strongly as ever that full trade in
beef and cattle products with Canada is justified by both the science
and world animal health guidelines.” USDA said it will consider
the over-30-months animals and products in a separate rulemaking. AMI said this development, as well as last week’s move by a
federal judge to stop the USDA rulemaking with a temporary injunction,
are a “blow to free trade.”
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Canadian Beef Industry Going
After World Markets as U.S. Drags Feet
The Canadian federal government announced this week
it will invest $50 million (US$41 million) in industry efforts to develop
new global
beef markets, and cited the “uncertainty” over the reopening
of the U.S. market as one reason for the marketing strategy shift.
The federal contribution comes on the heels of a $37-million contribution
from the province of Alberta to the Canadian Cattlemen’s Association
Legacy Fund, set up to increase market development.
In a related development, Cuba announced it will resume trade with
Canada in both live animals and beef.
“The uncertainty created by the closure of many borders, including
the U.S., to live Canadian cattle makes it imperative we accelerate
our efforts to regain and expand our markets,” said Canadian
Agriculture Minister Andy Mitchell, according to reports.
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Branded Beef Law Signed By South Dakota Governor
A state branded beef law, a slap in the face to federal inaction
on country-of-origin labeling, was signed this week by South Dakota
Gov. Mike Rounds, with supporters saying consumers will pay a premium
to find out where their beef comes from and this means higher returns
for ranchers. Under the new system, the state government is literally
putting a seal of approval on South Dakota-grown beef, officials said.
Consumers will be able to go to a state website and using the code
on the meat label, track the animal from birth through feedlot to packing
plant. Only cattle which can be tracked electronically through an ear
tag and are raised and slaughtered according to state program standards
will qualify for a state seal assuring quality and safety. Animals
would be fed, raised and slaughtered within South Dakota.
While initially used with premium products, state officials say they
hope to expand the program to natural beef production, i.e. no use
of hormones or other chemicals, a move that would allow the products
to sell well in Europe.
Producers who voluntarily enroll in the Certified Beef program will
pay licensing fees, which will be used to finance the system.
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U.S. Food Supply Remains Vulnerable to Terrorists
Too few border inspections of imported food and limited
access to vaccines are keeping the U.S. food supply vulnerable to terrorist
attack,
said the General Accountability Office (GAO) this week in a report.
While much has been done, more needs to be implemented.
Since USDA passed border inspections to the Department of Homeland
Security (DHS) in 2002, inspections have fallen from nearly 41 million
in 2002, to 37.5 million last year. DHS said a lack of inspectors is
partially to blame for the drop, and said it intends to hire an additional
500 inspectors within 12 months.
Of equal concern is the intentional introduction of
animal and poultry diseases. While most of the impact would be economic,
there are additional
concerns about such diseases as avian influenza which have human health
consequences. The greatest concern is introduction of foot-and-mouth
disease (FMD), which if introduced into the U.S. herd would cost about
$5 billion.
USDA was urged to come up with a cost/benefit analysis of stockpiling
animal vaccines and evaluate rapid diagnostic tests for use at the
site of an outbreak, while training veterinarians to recognize foreign
animal diseases.
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Harkin, Goodlatte Decry Budget Numbers;
Over 100 Groups Sign On To Congressional Letter Opposing Cuts
Budget proposals released this week by the House and
Senate budget committees “strike directly at vital initiatives…and
would reverse progress made in the 2002 Farm Bill,” said Sen.
Tom Harkin (D-IA), ranking member of the Senate Agriculture Committee.
In a related
development, more than 100 agriculture, consumer and hunger organizations
signed a letter to Congress demanding all discretionary and mandatory
spending at USDA be held at 2002 Farm Bill levels.
At the same time, House Agriculture Committee Chair
Rep. Bob Goodlatte (R-IA) said he was “alarmed” by the
revised Congressional Budget Office’s (CBO) estimates on the
Administration’s
FY2006 budget proposal.
Harkin said it is shortsighted and misguided to slash
agriculture and nutrition budgets by $5 billion over the next five
years as recommended by President
Bush; the Senate budget proposal would cut agriculture programs by
nearly $3 billion over the same five years.
Said Goodlatte of the CBO estimates on the White House budget: “I
am alarmed by the revised CBO estimates…These estimates call
for cuts of $9.1 billion in programs under the jurisdiction of the
Agriculture Committee over five years. This is unacceptable. The level
of reduction, which is proportionately far higher than in any other
budget area, would seriously impair the functionality of the committee’s
programs. I will work with my colleagues to insure that reductions
of this magnitude do not stand.”
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House Passes Highway Bill with Ag Hours of Service Amendment
The House easily passed an omnibus highway reauthorization
package this week, a package including many sought-after protections
including making permanent the exemption for hours-of-service rules
for agriculture commodities and farm supplies.
The bill authorizes $283.9 billion over six years
for highway construction, public transportation, road safety programs,
and to repair bridges. The
bill also includes special projects – and money – for every
member’s House district. It clarifies that states contributing
gasoline tax money to the highway trust fund would get back 95% of
their contribution without penalizing states that contribute less.
The hours-of-service amendment, offered by Rep. Jerry
Moran (R-KS) clarifies the definition of “agricultural
commodities” includes
livestock, milk and other farm products, and while making the ag exemption
permanent, prevents the secretary of transportation from rolling back
or revoking the exemption.
The Senate must now pass its version, with Sen. Conrad
Burns (R-MT) proposing the hours of service language. Congress failed
to pass the
highway bill over the last 18 months in the face of a White House veto
threat if the bill contributed to the federal deficit.
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New Bills
A number of new bills have been introduced. Click
here to send a request for a copy of the text or more information about
the bill.
S.531
A bill introduced by Sen. Rick Santorum (R-PA) would amend the Agricultural
Adjustment Act to exempt certain varieties of tomatoes from agricultural
marketing orders.
S.566
Sen. John Rockefeller (D-WV) offered the "Medicare Dual Eligible
Prescription Drug Coverage Act of 2005" which would continue State
coverage of Medicaid prescription drug coverage to Medicare dual eligible
beneficiaries for 6 months while still allowing the Medicare part D
benefit to be implemented as scheduled.
S.544
Sen. Jim Jeffords (I-VT) introduced the "Patient Safety and Quality
Improvement Act of 2005" to improve patient safety
S.548
A bill offered by Sen. Kent Conrad (D-ND) would encourage owners and
operators of privately held farm, ranch, and forest land to voluntarily
make their land available for access by the public.
S.572
Sen. Daniel Akaka offered the "Homeland Security Food and Agriculture
Act" to give additional biosecurity responsibilities to the Department
of Homeland Security.
S.573
Sen. Akaka also introduced the “Agricultural Security Assistance
Act of 2005" to improve the response of the Federal Government
to agroterrorism and agricultural diseases.
S.576
Legislation introduced by Sen. Robert Byrd (D-WV) would restore the
prohibition on the commercial sale and slaughter of wild free-roaming
horses and burros.
S.581
Sen. Lindsey Graham (R-SC) proposed a bill to contain the costs of
the Medicare prescription drug program.
H.R.1135
Rep. Don Sherwood (R-PA) introduced legislation to amend the Agricultural
Adjustment Act to exempt certain varieties of tomatoes from agricultural
marketing orders.
H.R.1144
Rep. Thomas Allen (D-ME) offered the "Medicare Dual Eligible Prescription
Drug Coverage Act of 2005" which would continue State coverage
of Medicaid prescription drug coverage to Medicare dual eligible beneficiaries
for six months while still allowing the Medicare part D benefit to
be implemented as scheduled.
H.R.1200
Rep. Jim McDermott (D-WA) introduced a bill to provide for a universal
health care system.
H.R.1227
Legislation introduced by Rep. Judy Biggert (R-IL) would prohibit health
insurance and employment discrimination on the basis of genetic information.
H.R.1254
A bill offered by Rep. Collin Peterson (D-MN) would establish an electronic
nationwide livestock identification system and promote a review of
Department of Agriculture responses to livestock disease outbreaks.
H.R.1256
Rep. Collin Peterson (D-MN) proposed a bill to amend the Animal Health
Protection Act to exempt certain animal identification information
from disclosure under the Freedom of Information Act.
H.R.1260
Rep. Thomas Reynolds (R-NY) offered legislation to extend contracts
for national dairy market loss payments through fiscal year 2007
and to increase the payment quantity authorized.
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