Congress Continues to Work, Senate Provides
2006 Schedule
Returning for a post-Thanksgiving blitz, the House reconvened
this week, with the Senate returning on Monday. Tentative Senate adjournment
is set for
December 15; however, party leaders have warned they may work into the
weekend. House leaders have warned their members
that the House could be in as late as Dec. 23 if necessary. In further scheduling, Senate Majority Leader Bill Frist (R-TN) announced
the Senate would convene for the second session of the 109th Congress
Jan. 18 and marked Oct. 6 as next year's target adjournment date. The
House legislative schedule for 2006 is not yet available.
In 2006, the Senate will be in recess from:
Feb. 20 - 24, Presidents' Day
March 20 - 24, St. Patrick's Day
April 10 - 21, Easter
May 29 - June 2, Memorial Day
July 3 - 7, July Fourth
Aug. 7 - Sept. 4, August Recess
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Labor-H Negotiations Continue
The Labor, Health & Human Services Appropriations conference committee
is scheduled to once again meet and mark up the bill on Monday evening,
and it may come to the Senate and House floors soon thereafter.
Last month, the House voted down the negotiated conference report
on the Labor-H bill which includes funding for the National Institutes
of Health (NIH) and the Health Resources and Services Administration
(HRSA). The previous House and Senate negotiated conference report
cut $1.4 billion from last year's spending levels, raising the ire
of members of both parties.
However, a failed attempt to address Democratic concerns makes the
future of the bill unclear. House Democrats attempted to instruct the
conferees to include $4.183 billion for the Low-Income Home Energy
Assistance Program (LIHEAP), an increase of $2.176 billion over the
House bill and $2 billion over the Senate bill.
Senate appointed conferees: Arlen Specter (R-PA), Thad Cochran (R-MS),
Judd Gregg (R-NH), Larry Craig (R-ID), Kay Bailey Hutchison (R-TX),
Ted Stevens (R-AK), Mike DeWine (R-OH), Richard Shelby (R-AL), Pete
Domenici (R-NM), Tom Harkin (D-IA), Daniel Inouye (D-HI), Harry Reid
(D-NC), Herbert Kohl (D-WI), Patty Murray (D-WA), Mary Landrieu (D-LA),
Richard Durbin (D-IL) and Robert Byrd (D-WV).
House appointed conferees: Ralph Regula (R-OH), Ernest Istook (R-OK),
Roger Wicker (R-MS), Anne Northup (R-KY), Kay Granger (R-TX), John
Peterson (R-PA), Don Sherwood (R-PA), Dave Weldon (R-FL), James Walsh
(R-NY), Jerry Lewis (R-CA), David Obey (D-WI), Steny Hoyer (D-MD),
Nita Lowey (D-NY), Rosa DeLauro (D-CT), Jesse Jackson (D-IL), Patrick
Kennedy (D-RI), and Lucille Roybal-Allard (D-CA).
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House Passes Tax Reconciliation Package
The House passed its tax reconciliation bill, a package
worth $56 billion, including continuation of the 15% capital gains
and dividend
rates through 2010, and is now looking to contentious conference committee
action with the Senate. The Senate avoided extending the dividend rate,
but instead created a safe harbor for middle income taxpayers from
paying the alternative minimum tax.
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FDA Holds Risk Communication Public Meeting
On December 7 & 8 FDA held a public meeting to
hear stakeholder's views of the best ways to communicate pharmaceutical
product risk information to consumers and health care providers. The
agency’s goal in these meetings was to solicit responses to a
series of questions on the current mechanisms used to inform the public
about product risks, as well as to hear recommendations for other approaches.
Specifically, FDA asked about Patient and Healthcare
Professional Information Sheets, Talk Papers, Public Health Advisories,
Press Releases, MedWatch Listserv Safety Updates, Patient Safety News,
the Center for Drug Evaluation and Research (CDER) Educational Campaigns,
and the CDER Internet site. The agency asked stakeholders to discuss
the strengths and weaknesses of existing communication mechanisms,
what is known about how the public perceives and uses the information
FDA now provides, whether the right kinds and amounts of information
are provided to facilitate medical decision-making, and what is needed
to ensure appropriate communication to people with special needs such
as low literacy or limited English language capability.
Several comments were made regarding additional information
sources for risk data, including Medicare and Medicaid data, which
some said could be less useful than desired. Dr. Sidney Wolfe, on behalf
of Public Citizen, rejected a suggestion by the National Council on
Patient Information and Education that CMS could communicate risk information
to Medicare beneficiaries because such a system would be “unworkable.” Wolfe
did, however, suggest FDA could include drug risk information in the
envelopes with social security checks.
FDA plans to review all of the information presented
at the public meeting, along with other comments sent to the agency
in writing, to determine additional steps or modifications to its risk
communication.
As background information for the meeting, the agency
highlighted several initiatives, including improvement of electronic
communication through a standardized electronic drug label, available
via the National Library of Medicine DailyMed website (to be available
over the next year) and several newly awarded contracts to give the
agency access to drug information and pharmacoepidemiology databases.
Also noted were the appointment of a new director for the Office of
Drug Safety and the establishment of the Drug Safety Oversight Board.
FDA also continues to wait for the report of an ongoing Institute of
Medicine study on the effectiveness of the U.S. drug safety system.
The IOM has held three meetings on this matter and has scheduled a
fourth meeting for January 18-20, 2006.
Return to top Upcoming
House E&C Hearings on Pharmaceuticals
The House Energy & Commerce subcommittee on oversight & investigations
is holding a hearing the afternoon of December 13 on “Safety
of Imported Pharmaceuticals: Strengthening Efforts to Combat the Sales
of Controlled Substances Over the Internet.”
Also in the oversight & investigations subcommittee will be a
December 15 hearing on “Oversight and Administration of the 340B
Drug Discount Program: Improving Efficiency and Transparency.” In
1992, Congress enacted Section 340B of the Public Health Service Act
(the PHS Act), establishing the 340B Drug Discount Program. This Federal
discount program requires pharmaceutical manufacturers to lower outpatient
drug prices for over 10,500 qualified Federal grantees, including community
health centers and public hospitals.
A witness list has not yet been published for either hearing. For
more information please visit http://energycommerce.house.gov/.
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President Alerts Biz Leaders on Bird Flu; Congress May Cut Funds
The White House this week sent out an email message to U.S. business
leaders urging them to work within their communities to prepare employees
and communities, including developing specific plans “for the
ways that you would protect your employees and maintain your operations
during a (bird flu) pandemic.” Meanwhile, on Capitol Hill it
appears appropriators may give President Bush less than half of the
$7 billion he requested to prepare for a bird flu outbreak in this
country.
On the business alert, the letter – signed by the secretaries
of Commerce, Health & Human Services and Homeland Security – includes
the admonition that companies which provide critical infrastructure
services, including power and telecommunications, have a “special
responsibility to plan for continued operation in a crisis…” The
alert also included a Centers for Disease Control set of guidelines
on preparing for the prospect of an influenza outbreak. The letter,
with links to related documents, can be found at www.pandemicflu.gov/plan/panbusletter.html.
On the money side, Senate Majority Leader Bill Frist (R-TN) is urging
lawmakers to support the President’s full request, but acknowledged
some members are questioning whether so much money is needed immediately.
Return to top Japan Could Resume U.S. Beef Imports This Month
Japanese and American media are saying that a favorable report on
the safety of U.S. beef issued this week by the Japanese Food Safety
Commission is the last major hurdle to resuming U.S. beef trade. Sales
into that Asian market will likely begin this month. The formal announcement
from the Japanese government is expected Monday, December 12.
The commission’s report said if U.S. processors
remove specified risk materials (SRM) from animals 20 months old or
younger – the
age of Japan’s youngest case of BSE – then there is a “very
low” risk of BSE contamination. This week, teams of Japanese
technicians were in the U.S. to verify that U.S. meat slaughter facilities
could meet the export requirements under USDA’s bovine export
verification (BEV) program.
U.S. beef sales to Japan have been banned since December, 2003 after
the discovery of a BSE-infected Canadian import cow in Washington State.
That cow shut off a market valued at more than $1.4 billion to U.S.
cattle producers and processors who supplied more than a quarter of
all Japanese beef demand, estimated in 2003 to be 930,000 tons. Some
speculate the age restriction will limit U.S. exports to about 20%
of pre-ban sales.
The Japanese report said the U.S. should ban SRM from all animal feeds,
which FDA proposed last month. The report also recommended continuation
of USDA’s enhanced animal surveillance program, which USDA said
last week it will continue for at least the first quarter of 2006.
The Japanese government intends to hold nine public information sessions
around the country to explain the decision to resume imports to consumers.
One newspaper opinion poll found nearly 67% of Japanese consumers are
wary of U.S. efforts and the safety of the products.
Return to top DOHA Round Results Still In Question; Chambliss Warns of Senate Action;
House Approves Bahrain FTA, With Peru Deal Next On Deck
While no one is holding their breath waiting for a breakthrough in
agriculture trade negotiations next week in Hong Kong when the trade
ministers for General Agreement on Tariffs and Trade (GATT) countries
convene, Sen. Saxby Chambliss (R-GA) warned this week Congress won’t
rubber stamp just any deal struck on ag trade. Chair of the Senate
Agriculture Committee, Chambliss cancelled plans to attend the meeting,
Meanwhile, the House approved easily a free trade agreement with Bahrain,
a small nation in the Middle East, where the U.S. headquarters the
U.S. Navy’s Fifth Fleet. Under the agreement all American consumer
and industrial products will become duty free, and 98% of agricultural
tariffs will be eliminated immediately. The remaining 2% will be phased
out over 10 years.
On the Peru deal, the U.S. and Peruvian governments announced this
week they reached agreement on a free trade agreement. The U.S. government
began talks with Peru, Ecuador and Colombia about a year ago, with
Peru striking the first deal. Chambliss said several proposals could cause Congress to walk away
from ratification of a GATT treaty, including attempts to force the
U.S. to overhaul its cotton program without corresponding increases
in foreign market access. A separate proposal by the European Union
(EU) to give developing nations a deal on all tariffs will also be
a deal breaker with Congress if no U.S. increased market access results.
Referring to the EU’s refusal to up its offer on subsidy cuts
due to French opposition, Chambliss said he found it “rather
shameless” for the EU, and France particularly, to “hide
behind the cloak of African poverty” to protect its farmers,
especially when the EU’s subsidies are four times as high as
the U.S. The EU provides preferential tariff treatment for African
nations on all but weapons sales. Sen. Charles Grassley (R-IA), chair
of the Senate Finance Committee, said the EU refusal creates “a
real stalemate” in Hong Kong because it provides insufficient
market access.
Return to top USDA Sets Farm Energy Cost Plan
USDA announced this week a “comprehensive energy strategy” and
the creation of a USDA Energy Council to help farmers and ranchers
cope with high energy costs while seeking long-term energy
solutions. The Energy Council will examine existing department programs
to ensure they fit within the strategy and “ensure agricultural
producers have a place at the table for national energy discussions.”
A main feature of the new strategy is the development of risk management
tools through USDA’s Risk Management Agency (RMA) to manage energy
and energy-related costs. RMA plans a spring workshop to seek ideas
and promote discussion, while the Farm Services Agency (FSA) has been
directed to use “all available budget authorities” and
if necessary, seek permission to redirect resources to its guaranteed
and direct loan programs for farmers who need credit.
Another big part of the plan is a partnership between USDA, EPA and
the Department of Energy to fully achieve the Renewable Fuels Standard,
the alternative fuels mandate included in the recently enacted omnibus
energy bill. Full details of the new strategy can be found at www.usda.gov/energy.
Return to top Cochran Doubles Hurricane Relief Plan, Includes Ag Emergency Money
A Senate hurricane relief package, nearly double the $17.1 billion
requested by the White House and carrying nearly $4 billion in agriculture
emergency assistance, is being championed by Sen. Thad Cochran (R-MS).
Chair of the powerful Senate Appropriations Committee, Cochran cobbled
together his package so that it includes offsets taken from unspent
Iraq reconstruction monies.
Cochran also has plans to tack the relief package on to the defense
appropriations measure next week when it hits the Senate floor. The
White House rejected the Cochran plan almost immediately, but with
assistance from Mississippi Gov. Haley Barbour, Cochran has convinced
House leadership of the wisdom of his general approach if not the details.
While Cochran argued rebuilding homes, schools, levees, infrastructure
and roads in the Gulf Region constitutes legitimate emergency spending
which should not require offsetting program cuts in other areas, the
House signaled early on in the hurricane relief debate it would not
accept a package that adds to the federal deficit.
Cochran’s plan carries a $35.5-billion price tag, that includes
the $17.1 billion requested by the White House for hurricane relief,
but would reallocate that funding from the $62.3 billion originally
appropriated by Congress for FEMA this fall. Cochran tacks on another
$18.4 billion that includes $3.9 billion in farm disaster aid, including
rebuilding Gulf fisheries and midwestern drought assistance; $11.5
to assist home owners without flood insurance; $1.5 billion to rebuild
New Orleans’s levees and $1.5 billion for education, child care
and social services.
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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.CON.RES.67
Sen. Norm Coleman (R-MN) offered a concurrent resolution urging Japan
to honor its commitments under the 1986 Market-Oriented Sector-Selective
(MOSS) Agreement on Medical Equipment and Pharmaceuticals.
S.2052
A bill offered by Sen. Pat Roberts (R-KS) would provide a credit to
certain agriculture-related businesses for the cost of protecting
certain chemicals.
H.RES.577
Rep. Phil English (R-PA) offered a resolution expressing the sense
of the House regarding the conditions for the U.S. to become a signatory
to any multilateral agreement on trade resulting from the World Trade
Organization's Doha Development Agenda Round.
H.R.4392
Rep. Thomas Allen (D-MA) introduced a bill that would provide for the
importation of pharmaceutical products under a compulsory license
as provided for under the World Trade Organization.
H.R.4395
Legislation proposed by Rep. John Conyers (D-MI) seeks to provide for
an improved voluntary Medicare prescription drug benefit and greater
access to affordable pharmaceuticals.
H.R.4399
A bill by Rep. Michael Fitzpatrick (R-PA) would extend the annual enrollment
periods of the Medicare prescription drug benefit program and under
the Medicare Advantage program, and suspend Medicare prescription
drug late enrollment penalties for two years after the initial enrollment
period.
H.R.4406
Rep. Mark Kennedy (R-MN) introduced language that would establish a
criminal penalty for defrauding individuals in connection with enrollment
under a prescription drug plan or under the Medicare Advantage Program.
H.R.4409
Rep. Jack Kingston (R-GA) offered a bill that would reduce the dependence
of the U.S. on foreign oil through the use of alternative fuels and
new vehicle technologies.
H.R.4410
Rep. John Larson (D-CT) proposed legislation that would extend the
initial enrollment period for Medicare prescription drug benefits
through May 15, 2008 and waive penalties for late enrollment before
June 1, 2008.
H.R.4429
A bill introduced by Rep. John Tierney (D-MA) would amend the Federal
Food, Drug & Cosmetic Act with respect to drug safety.
H.R.4449
Rep. Frank Pallone, Jr. (D-NJ) offered language that would impose a
temporary windfall profit tax on crude oil, allow a credit against
tax for qualified fuel-efficient vehicles placed in service during
the taxable year and establish the Energy Assistance Trust Fund.
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Inside
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