Ways & Means Chair Stakes Claim on Social
Security
Surprising some of his colleagues and the White House, House Ways & Means
Committee Chair Bill Thomas (R-CA) announced late last week his intention
to develop legislation to address Social Security problems. He indicated
that the Committee, with its Social Security subcommittee, would begin
a series of hearings this month, which would lead to the development
of legislation, probably in June.
The first hearing, “Alternatives to Strengthen Social Security,” is
scheduled for May 12. Tentatively, the following witnesses are planned:
Lawrence Lindsey, Chair of The Lindsey Group; Robert Pozen, Chair of
MFS Investment; Sylvester Schieber, Director of U.S. Benefits Consulting
at Watson Wyatt; Eugene Steuerle, Senior Follow at Urban Institute;
Michael Tanner, Director of Health and Welfare Studies at Cato Institute;
and, Lawrence Hunter, Chief Economist at Free Enterprise Fund.
Thomas and Social Security Subcommittee Chair
Rep. Jim McCrery stated that Social Security reform is necessary
to
protect future
generations and the Ways & Means Committee “will respond
to the President’s challenge” to undertake reform. It is
expected that legislation will include provisions to accomplish President
Bush’s
goal of allowing for private investment accounts, but also will incorporate
some pension-reform “sweeteners” that could attract support
from otherwise skittish lawmakers. Thomas has been highly successful
in shepherding controversial and difficult legislation through the
process, not only to House passage but often to enactment, so his optimism
regarding Social Security is neither unfounded nor surprising.
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Energy & Commerce Committee Discusses
Flu Vaccine
At a House Energy & Commerce Oversight and Investigations
Subcommittee hearing on Wednesday, Dr. Julie Gerberding, Director
of the
Centers for Disease Control and Prevention; Dr. Jesse Goodman, Director
of FDA’s Center for Biologics Evaluation and Research, and Dr.
Bruce Gellin, Director of the HHS National Vaccine Program discussed
efforts at the federal level and with the industry, to ensure the availability
of an adequate supply of flu vaccine next year.
Committee Chair Rep. Joe Barton (R-TX) and Subcommittee
Chair Ed Whitfield (R-GA) both noted the importance of taking early
action to avoid a
flu vaccine shortage similar to last year. Rep. Michael Burgess (R-TX)
noted the flu vaccine shortage was symptomatic of other, more fundamental
problems regarding vaccine availability, not just confined to flu.
For example, he said, price controls and a low profit margin are two
reasons the vast majority of vaccines have no more than two manufacturers.
Gerberding and Gellin expressed optimism that cooperative
and coordinated strategies, based on lessons learned from last year’s
flu vaccine shortage, will help prevent similar situations in the future.
They
agreed, however, a number of factors contribute to a fragile vaccine
infrastructure, and more needs to be done to consider ways to encourage
companies to stay in or enter the vaccine business. Goodman
indicated the FDA has continued to work with the industry to try to
avoid a situation
where manufacturing problems, or other FDA-related issues, result
in product shortages.
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House Government Reform Committee Joins Chorus of Voices
on Drug Safety
On May 4, the House Government Reform Committee held
a hearing on “The
Roles of FDA and Pharmaceutical Companies in Ensuring the Safety of
Approved Drugs.” Committee Chair Tom Davis (R-VA) indicated the
Committee had conducted an investigation after market withdrawal of
Vioxx. They sought to evaluate the actions of FDA
and
Merck, not only to look at this specific situation, but also to determine
how
FDA
and
the private sector can work more effectively to achieve better
post-market surveillance. Davis stated his interest
in making sure FDA has taken, or is taking, necessary steps to improve
interaction between the review components and post-market safety
components of the agency. He also stressed the need for effective,
timely, and accurate communication with the public about product
safety. Davis indicated the
Committee
intends to continue its oversight in this area.
Testifying for FDA, Dr. Steven Galson, Acting
Director of the Center for Drug Evaluation and Research, discussed
the spectrum
of activities
FDA undertakes to evaluate product safety at both the pre- and post-market
stages. He reinforced FDA’s commitment to integrated and coordinated
working relationships between the Office of New Drugs and the Office
of Drug Safety, and noted a number of steps taken to enhance this.
He also provided data indicating the large increase in resources that
has gone into the Office of Drug Safety over the last several years.
In response to questions about the potential impact of the Prescription
Drug User Fee program on drug safety, Galson pointed to statistics
indicating that the rates of product withdrawal are not different,
post-user fees, than prior to initiation of the program. He went on
to say that current user fees provide resources for drug safety
activities, including funds to hire additional personnel in the Office
of Drug
Safety.
Merck's Vice President for Global Strategic Regulatory
Development, Dennis Erb, Ph.D., talked about the company’s post-market
studies of Vioxx, emphasizing that the results of these studies were
reported
promptly to FDA. He stated the company’s decision to remove the
product from the market after one study showed an increased risk of
cardiovascular events in some patients was based both on
concerns about the data and the fact that
patients
had other therapies available. Erb stated that
in light of these facts, product withdrawal “was the responsible
course to take.”
John E. Calfee, American Enterprise Institute, noted
the difficulties of communicating drug safety issues appropriately
and of convincing
healthcare providers and others to report safety problems. The current
tort liability system, he said, is partly responsible for the reluctance
to report. Calfee also called attention to criticisms – many
addressed post-user fees – that an overly cautious approach to
drug approval denied patients needed therapies. He expressed concern
that current publicity and unrelenting criticism of the agency could
cause a reversion to FDA’s historical “excessive
emphasis on safety” that slowed market entry of important products,
and disputed those who argue user fees have caused a lowering of standards
at the agency. He said the current situation is making it harder for
FDA to do its job and could result in a slowing of FDA’s
review times and drug development in general.
Dr. Michael Wilkes, Vice Dean of Medical Education
at the University of California, Davis, focused principally on promotion
and advertising
of prescription drugs, indicating that such promotion – especially
the detailing of products by company representatives – has a
significant impact on physicians’ prescribing practices. He argued
that promotional activities are not educational and require greater
regulation.
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2006 Farm Bill Race Begins:
USDA to Hold National ‘Listening Sessions,’ Senate Will
Hold Hearings, House Accelerates Likely Schedule
While still battling FY2006 ag budget cuts, Congress
and the Administration look to be setting up a horse race to see which
branch will start moving
first on the 2006 Farm Bill. Secretary of Agriculture, Mike Johanns,
this week announced a series of national “listening sessions.” The
Senate Agriculture Committee also announced its own hearings. The
House Agriculture Committee, traditionally first out of the gate and
more
deliberate in its approach to farm policy, may accelerate its schedule
to retain its leadership role.
The accelerated Farm Bill gestation process is significant
because the Bush White House – and Congress – are faced
with trying to reverse some of the program retreats enshrined in the
2002 Farm
Bill. At that time, Congress walked away from the “Freedom
to Farm” decoupling
of the 1996 omnibus farm package and returned to the direct farm payment
approach many hoped was a thing of the past. Also at play are the stagnated
world trade discussions over the
level
of subsidies industrialized nations pay to their farmers, as well as
demands by developing countries that these payments end so as to level
the
global trade playing field.
Johanns said of his announcement, “This is
not going to be a session where we just shoot the bull.” This
signals
a marked departure from the Bush Administration’s approach to
its first Farm Bill in 2002 where it basically sat on the sidelines
during legislative
drafting, then unsuccessfully tried and shape at least some
of the bill’s shifts in
policy. No schedule for the sessions has been released by USDA.
Johanns' announcement also has the fingerprints of
newly-minted Deputy Secretary Chuck Conner, who is trying to build
a strong internal
legislative and policy team within USDA. However, the department still
lacks an assistant secretary for legislation; word on the street is
the Administration is looking for a well-known figure to fill that
slot. The White House budget recommendations also signal
the direction the Administration may be moving. For himself, Johanns
says he wants to talk about “supporting the next generation of
farmers,” conservation and infrastructure issues.
Meanwhile, Sen. Saxby Chambliss (R-GA), chair of the
Senate Agriculture Committee, said the committee will hold hearings
in Washington and
around the country to get input from stakeholders on the direction
farm policy development should go. The Senate, during the last farm
bill, was essentially steamrolled by the House where more than 35 nationwide
hearings were held. The bipartisan approach of then Chair
Larry Combest (R-TX) and former ranking member Rep. Charlie
Stenholm (D-TX) created an almost insurmountable political bloc.
The USDA and Senate action likely will shift the House Agriculture
Committee’s schedule for hearings and other considerations. A
high ranking staffer said this week that rather than waiting for 2006
to begin hearings, the committee will likely begin its effort late
this summer or early fall.
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Portman Hails “Ag Breakthrough” in European Meeting on
Subsidies
In his first official outing as the newly confirmed
U.S. Special Trade Representative, Ambassador Rob Portman this week
told reporters in
Paris he believes the U.S. and other nations have reached a deal to “jump
start” the Doha Round of GATT trade talks. He looks forward to
a formula by which countries can compare agricultural
tariffs.
Portman
said he
was hopeful that by the end of July countries should be able to see
how their respective payments stack up against other nations, and how
these schemes affect specific products and nations.
The European Commission (EC) said it has initiated
a breakthrough on ag tariff
calculations. The EC said “we
must now move rapidly and drive forward on all three parts of the agriculture
talks,” citing reform within the European Union’s (EU)
common agricultural policy (CAP) to allow members to come to the table
and discuss market access, domestic payments and export subsidies.
Brazil called the tariff agreement a “gateway” to
further talks. This is the same country which led less-developed nations
in a walkout during GATT talks in Cancun, Mexico three years ago over
U.S.
and European
foot-dragging
on farm subsidy issues.
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USDA Economist Says U.S. Payments Could Be Cut in Half by GATT
While the House Agriculture Committee subcommittee
hearing this week was about federal crop insurance, the question to
USDA’s Chief
Economist, Keith Collins, was about the impact of GATT on U.S. farm
subsidies and how USDA can fashion new efforts within existing programs
to help
maintain farm income. Collins said the U.S. allowance of about $19
billion in “trade distorting” subsidies could be cut by
as much as half by a GATT agreement based on the “hypothesis” that
the U.S. would want greater access for exports.
He said USDA might turn to a broader crop insurance
program given insurance payments are not classified as subsidies
under GATT,
but rather as “de minimis” payments. The only problem with
this approach, Collins noted, is such payments are limited to 5% of
total U.S. production, or $10 billion today. The ability to use crop
insurance would depend on what other programs are classified as de
minimis and the level of allowable de minimis payments after negotiations
are done, he said.
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“New” Dems Come Out Against CAFTA Over Labor Protections
The New Democrat Coalition, a group of 40 moderate
House Democrats, called for rewriting CAFTA labor provisions
or they will
oppose approval of the controversial treaty. The announcement compounds
an already tough fight for CAFTA approval based on demands by the U.S.
sugar industry that domestic producers receive greater protection from
sugar imports.
CAFTA supporters continue to say there are enough
bipartisan votes to pass the trade agreement. However opposition
leaders said it’s
not a matter of tweaking the agreement to make Democrats happy, but
rather a need for a complete renegotiation of sections of the pact.
Insiders say the new Democratic opposition means the White House may
have to cut special sector-by-sector deals to win Democratic support.
The Dems said part of their opposition stemmed from
what they consider a failure by the Bush Administration to reach out
to them to build
a consensus over such issues as trade adjustment assistance. The Administration
says it’s talked with many key Democrats about these issues,
with Ambassador Rob Portman specifically giving Democrats from textile
producing states assurances he will negotiate a fair deal for them.
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Goodlatte Introduces Voluntary COOL Bill
Legislation to make country-of-origin labeling (COOL) voluntary was
introduced this week by House Agriculture Committee Chair Bob Goodlatte
(R-VA) and 33 bipartisan supporters.
Goodlatte’s bill will require the Secretary
of Agriculture to create a voluntary program to allow producers to
work with processors
and retailers to provide labeling information “that informs consumers
and benefits products.” This translates into producer-retailer
permission to label beef, pork and lamb as products of the U.S. if
they’re processed from animals born, raised and slaughtered in
the U.S. Further, USDA would be required to create a “unique
label” indicating country of origin. Records would have to be
maintained to verify claims and compliance, and violators of the program
would be subject to civil penalties of up to $10,000.
COOL was mandated for meats, fruits and selected other commodities
by the 2002 Farm Bill and after much bitter debate and two years of
legislative wrangling, opponents of mandatory COOL were able to get
appropriators to cut off spending on the program. USDA estimated management
costs and industry compliance costs for mandatory COOL would reach
billions of dollars.
Return to top House OSHA Reform Price Tag Drops; Senate Hearings to Begin May 10
The House Education & Workforce Committee have
blessed its chamber’s version of the Occupational Safety and
Health Organization's (OSHA) reform legislation. With cost
estimates for the two bills having been reworked to make them more
palatable, the
Senate plans to hold the first of its OSHA reform hearings May 10.
The Congressional Budget Office (CBO) told Rep. Charlie
Norwood (R-GA), the House reform bills’ chief author, that his
legislation to allow employers to contest agency citations after OSHA’s
15-day deadline and setting up the Review Commission as an agency “deliberative
body,” will not have significant impact on the federal budget.
Increasing the number of commissioners from three to five would cost
about $1 million next year and $6 million in years 2006-2007. Allowing
small employers to recoup attorney fees if they fail to contest
an OSHA citation would cost about $4 million next year
and
$39 million
during 2006-2010.
House floor action may happen this month or in June. The Senate will
take a look at identical legislation during a subcommittee hearing
May 10, with subpanel chair Sen. Johnny Isakson (R-GA) saying he wants
the bills on the floor soon.
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BSE UPDATE
Delauro Still Wants Mandatory Testing of All Cattle
On the heels of last week’s Kansas State University report
that the beef industry could have saved billions of dollars through
voluntary testing of export cattle for BSE, Rep. Rosa DeLauro (D-CT)
renewed her demand for mandatory testing of all nonambulatory cattle
and all cattle over 30 months of age. She made the demand in a letter
sent this week to Secretary of Agriculture Mike Johanns.
DeLauro said the current APHIS testing program is flawed because
it is voluntary, not geographically viable and that most downers
are not being presented for testing. She also called for USDA to
immediately implement a mandatory national animal identification
program.
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University of Texas Team Thinks It May Be on to Blood Test for BSE
A team of University of Texas-Galveston neuroscientists
think they may be close to developing a blood test to detect transmissible
spongiform encephalopathies (TSE) in humans and animals, including
BSE and Alzheimer’s
Disease. The team, citing the years it generally takes rogue prions
to cause a TSE in humans and animals, reported in the April edition
of the journal Cell that using a technique to speed the detection
process by using ultrasonic waves to break up protein strands has
led to an early test of blood and food. The next step is to begin
work with human and animal samples, the team said.
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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.
H.RES.267
Rep. Darlene Hooley (D-OR) offered a resolution to providing for consideration
of H.R. 376, a bill that would authorize the Secretary of Health and Human
Services to negotiate prices for Medicare prescription drugs.
H.R.2068
Rep. Bob Goodlatte (R-VA) introduced a bill to establish a voluntary
program for country of origin labeling of meat. H.R.2133
A bill offered by Tammy Baldwin (D-WI) would guarantee comprehensive
health insurance coverage for all Americans.
H.R.2200
Rep. Dutch Ruppersberger (D-MD) introduced legislation to provide the
Secretary of Health and Human Services authority to negotiate outpatient
prescription drug prices under the Medicaid Program.
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