FDA Acting Commissioner Takes Additional Steps
Presumably in part to respond to concerns raised after he
was named acting FDA commissioner, Dr. Andrew von Eschenbach has taken specific
action. Several
members of Congress indicated concern that, if he remained in his post as director
of the National Cancer Institute (NCI), von Eschenbach would not be able to
devote the time and effort needed to head FDA. Additionally, it was suggested
a potential for conflicts of interest existed with regard to NCI-sponsored/conducted
studies under FDA’s regulatory purview.
In a memorandum sent to FDA employees September 30, von Eschenbach
stated while serving as acting FDA commissioner, he will not manage the day-to-day
operations of NCI. Instead, Dr. John Niederhuber, currently the Institute’s
deputy director for translational & clinical sciences, will serve as NCI
chief operating officer. This will free von Eschenbach to operate full-time
as acting FDA head. The memo stated further that von Eschenbach “will
not participate in certain FDA matters in which NCI is a party, unless the
Department requests that I participate on a case-by-case basis.” This
will include, he says, activities related to applications for approval submitted
by NCI or where an NCI scientist is a principal investigator for the relevant
studies and adverse event report oversight in NCI-related studies.
The Administration has indicated its commitment to name a
candidate as permanent FDA commissioner as soon as possible, although in statements
responding to
press inquiries, HHS Secretary Michael Leavitt noted there is no specific timetable
for the decision.
After a meeting with von Eschenbach October 4, Sen. Mike Enzi
(R-WY), chair of the Senate Health, Education, Labor & Pensions (HELP)
Committee, expressed his confidence in the appointee and also noted the importance
of
ensuring FDA
continue its important public health mission. He urged the nomination of a
permanent commissioner be quick, stating, “It is vital that the Senate
confirm a qualified nominee in an atmosphere free from political agendas as
quickly as possible.”
Return to top Avian
Influenza Inspires Flurry of LegislationIn response to reports of increased risk from avian influenza
and the possibility of a flu pandemic, members of Congress have introduced
legislation
designed
to assist the government in addressing the matter and removing disincentives
to the development of vaccines.
S. 1821, the Pandemic Preparedness and Response Act was introduced by Senate
Minority Leader Harry Reid (D-NV) and other Democratic senators.
This bill
would:
•
require the President to appoint a National Director of Pandemic Preparedness
and Response;
•
establish a Pandemic Influenza Preparedness Policy Coordinating Committee;
•
condition state receipt of bioterrorism funds on the state’s having
an acceptable flu response plan;
•
require procurement for the national stockpile of antivirals sufficient to
treat 50% of the population and vaccines sufficient to vaccinate health and
public health officials and others on the “front line;”
•
require the development of a national tracking and distribution system for
these and other necessary medications; and,
•
require other actions related to international coordination, health professions
training, research and public education. With regard to the purchase of vaccines, the bill would require
the HHS secretary to contract with manufacturers to make additional doses as
determined necessary
and to include in the contracts provisions related to compensating manufacturers
equitably for doses that, while requested, were not purchased. In addition,
the bill would require manufacturers to notify the secretary in advance of
a decision to discontinue manufacture of a flu vaccine. The bill also would
make it illegal, during a public health emergency related to pandemic flu,
for anyone to take “unfair advantage of the circumstances” by increasing
prices or to charge an “unconscionable excessive” price for a drug
or medical device related to treating or preventing the disease.
S. 1828, the Influenza Vaccine Security Act, was introduced
by Sens. Hillary Clinton (D-NY) (also a cosponsor of S. 1821) and Pat Roberts
(R-KS). Among
other provisions, the bill would authorize HHS to set yearly targets for flu
vaccine production, with manufacturers; to stockpile and have buy-back programs
and to provide technical assistance to manufacturers, including facilitating
approval and distribution of flu vaccine. HHS also would be required to conduct
additional training of FDA employees in regulating vaccines, establish a vaccine
tracking system, develop a coordinated federal-state team of health care workers,
and provide grants to states and state agencies for projects to increase vaccination.
Significantly, S. 1828 includes provisions to authorize liability protections
for manufacturers of flu vaccines, as well as distributors and health care
providers. The government would assume liability for injury or death associated
with qualified flu vaccines, and claims would be adjudicated under the Federal
Tort Claims Act. While time - and product - limited, these liability protections
appear somewhat of a breakthrough for a Democratic Senator.
H.R. 3970, introduced by Rep. Darrell Issa (R-CA), deals directly with the
liability issue. This bill strictly amends title 28 of the U.S. Code to provide
liability protections for manufacturers and others, related to vaccines and
countermeasures associated with pandemics and other health emergencies. Return to top
Durbin Offers, Withdraws Stimulants Amendment
During consideration of the Department of Defense appropriations
bill, Sen. Richard Durbin (D-IL) offered an amendment on stimulants, similar
to one he
has offered previously. The amendment would prohibit the use of DOD funds for
a military base store, commissary or exchange that sells dietary supplements
containing stimulants, unless the manufacturers of the products submit all
reports of serious adverse events to FDA.
In speaking about his amendment, Durbin emphasized he was “not on the
warpath against a daily vitamin tablet.” He noted some supplement products
containing stimulants are dangerous and discussed manufacturers who receive
adverse event reports, but refuse to disclose them.
Citing ephedra as one of his major concerns, Durbin discussed a recent court
ruling that FDA had overstepped its bounds by withdrawing all ephedra products
from the market. Durbin cited how immediately following the court ruling retailers
and others began promoting “ephedra is back” and selling products
that not only contained the small dosages of ephedra about which the court
ruled, but also products containing much larger and potentially dangerous doses.
Durbin said while ephedra has famously caused serious injury, it is not the
only stimulant ingredient about which there should be concerned.
According to Durbin, military personnel are susceptible to claims that supplement
products will enhance their performance and give them more energy, as they
constantly strive to be at peak performance. The amendment is a way, he said,
to ensure these personnel get accurate information about the risks of any of
these products they decide to purchase.
Sen. Mike Enzi (R-WY) asked Durbin to withdraw his amendment,
noting the underlying legislation the amendment seeks to address indirectly,
the Dietary Supplement
Health & Education Act (DSHEA), is in his HELP committee’s jurisdiction.
He said matters of supplement adverse events reporting is a high priority for
the committee and he would work with Durbin and others to address it. The exigencies
of hurricane Katrina, he said, have put many HELP committee issues on a back
burner, but they would deal with them as soon as possible.
Durbin asked for assurance the HELP committee would hold hearings
on the issue; Enzi assured Durbin the committee will deal with it, though he
did not commit
to holding hearings. Durbin stated, “If the Senator from Wyoming will
give me his assurance that this is a priority, that he will try to bring it
up before his committee in a timely way when appropriate, I understand he has
other priorities, if he will give me that assurance, I will withdraw this amendment.
I hope we can work together from this point forward.”
Return to top
House Passes Cancer Care Demonstration
Resolution
By a voice vote October 6, the House passed H.Res. 261, a “resolution
expressing the sense of the House of Representatives that the Centers for Medicare & Medicaid
Services should be commended for implementing the Medicare demonstration project
to assess the quality of care of cancer patients undergoing chemotherapy, and
should extend the project through 2006, subject to any appropriate modifications.”
The resolution is particularly directed to the program assessing quality of
care for Medicare beneficiaries receiving community-based cancer care. Introduced
in May by Rep. Ralph Hall (R-TX) and others, the resolution is supported by
oncologists, especially those treating patients in an outpatient/non-hospital
setting, whose reimbursement for drugs is affected by the change (in the MMA)
from an AWP-based to an ASP-based system. Prior to the new system going into
effect, oncologists argued strongly for – and achieved – a “transitional” payment
system recognizing quality indicators and additional costs associated with
providing drug therapies covered under Medicare Part B. The ongoing demonstration
program provided this, but initially was intended to last for one year.
The resolution urges that the program continue for an additional year and
be evaluated to determine what is the appropriate reimbursement methodology
to ensure cancer patients receive the highest quality care. In addition, the
resolution also urges the evaluation of quality indicators, including the “clinical
context in which chemotherapy is administered, and patient outcomes.”
The legislation was supported strongly in statements made on the House floor
by Hall, Rep. Nathan Deal (R-GA), chair of the Energy & Commerce Health
subcommittee, Rep. Sherrod Brown (D-OH), subcommittee ranking Democrat, Rep.
Nancy Johnson, chair of the Ways & Means Health subcommittee, and Reps.
Gene Green (D-TX), Sheila Jackson-Lee (D-TX) and Mike Ferguson (R-NJ). Return to top
Health IT Community Holds First Meeting
This week the newly formed American Health Information Community (the Community)
held its first meeting in Washington, DC. The Community has been established
to advise the secretary of HHS and recommend specific actions to achieve a
common interoperability framework for health information technology (IT) and
serve as a forum for participation from a broad range of stakeholders to provide
input on achieving interoperability of health IT.
The Community has 17 members including secretary of HHS Michael Leavitt who
serves as the chair. The remaining 16 members, selected by Leavitt, represent
a combination of key leaders in the public and private sectors. Leavitt said
he will be asking members of the Community to chair work groups that will be
tasked with very specific assignments. By the end of the year, he would like
the Community to have three to four working groups established with specific
goals, deadlines and a relationship with contractors.
Planning to meet every four to six weeks, the Community is moving forward
with a short-term agenda that includes the following:
•
establishing a public health working group on the need for a national bio-surveillance
system;
•
extensive active discussions on moving forward with quality monitoring and
reporting;
•
establishing a chronic disease monitoring group;
•
holding a briefing on e-prescribing, and
•
forming a working group on consumer driven electronic regulations.
The Community is also seeking the names of organizations and entities with
established health IT programs in order to have a full picture of the current
state of health IT and what potential exists.
Return to top FDA Proposes Changes to Its BSE Feed Rule Focusing
On SRM RemovalFDA this week published its long-awaited proposed changes to its BSE
ruminant feed rule, focusing as expected on specified risk material
(SRM) removal in all feeds, but backing dramatically away from the
proposals contained in last year’s advanced notice of proposed
rulemaking.
The following list of SRMs to be removed from all livestock and poultry
feed is taken from FDA’s press release:
“These high risk cattle materials prohibited
in the new proposed rule include: 1. the brains and spinal cords from cattle 30 months
of age and older,
2. the brains and spinal cords from cattle of any age not inspected
and passed for human consumption,
3. the entire carcass of cattle not inspected and passed for human
consumption if the brains and spinal cords have not been removed,
4. tallow that is derived from the materials prohibited by this proposed
rule if the tallow contains more than 0.15 percent insoluble impurities,
5. mechanically separated beef that is derived from the materials prohibited
by this proposed rule.”
Industry anticipated the abbreviated list of SRMs to be removed from
cattle feed, and most organizations in the industry support the
action at this point. The decision to remove these materials from all
feeds
is FDA’s attempt to curb any possible cross-contamination
of feeds and on-farm feeding.
It is also hoped at political levels the FDA proposal
will give comfort to the Canadian government to repropose or modify
its proposed feed
rule to harmonize the two country’s actions more closely. Sources
in Canada confirmed that while the ag minister has been briefed on
public comment on their proposal, he has been presented no formal options
paper. Further, government sources indicate no action on the Canadian
rule is expected before December.
The proposal is silent on restrictions on the use
of bovine blood/blood products and does not ban feeding of poultry
litter and plate waste.
Further, it does not require dedication of facilities, lines or transportation.
FDA said the removal of SRMs from all feeds makes these actions unnecessary.
In the case of blood/blood products, FDA said science and recent actions
by the OIE (World Animal Health Organization) show these products are
not routes of BSE infectivity.
However, the removal of all nonambulatory and dead
animals from the feed chain (points 2 and 3) has some segments concerned
such action
removes all economic incentives for most independent renderers to pick
up on-farm deadstock without charging significantly higher fees to
do so, and that removing younger animals that are nonambulatory or
feedlot deadstock is unnecessary. Most independent renderers are not
equipped to remove brains and spinal cords from deads and downers.
The upshot, some predict, will be a step back from deadstock pickups
for any species by independent renders who cannot justify the costs
of running trucks to pick up material that has no value.
At the same time, the proposed rule asks several questions about the
dead/downer sections of the proposal, as well as trying to gather additional
information about the environmentally safe disposal of the millions
of pounds of SRM material that will be generated if the rule is finalized
as proposed.
Most consumer activist groups said the rule does not go far enough
and should have banned all SRMs – the long list of central nervous
system tissues banned for human consumption and in consumer products – from
all feeds. Further, these groups also want FDA to ban all poultry litter,
plate waste and blood and blood products from feed.
The comment period on the rule runs 75 days and will
close on Dec. 19. The full text of the proposed rule can be found at
www.fda.gov/OHRMS/DOCKETS/98fr/02n-0273-npr0001.pdf.
Return to top
Johanns Lays Out Thoughts on Next Farm Bill
Secretary of Agriculture Mike Johanns yesterday told
a Washington, DC, ag audience that based on USDA Farm Bill Forums in
26 states, it’s
his opinion “the current farm bill … (is) perhaps the most
high-risk approach we could take for our nation’s farmers and
ranchers in the future.” Johanns stressed the department has
done no formal analysis of comments received at the forums, and his
address to a joint meeting of the Commodity Club and Food Group should
not be considered an outline of farm policy for the next farm bill.
Johanns said while USDA heard unanimous support for
rural development programs, “tremendous support” for USDA
conservation programs and “a lot” about U.S. competitive
and expanded overseas markets, there is a wide range of opinion on
farm support programs.
Small and minority farmers expressed frustration about the “lion’s
share” of federal support payments going to large operations.
Johanns said 3% of farmers receive nearly 30% of payments; medium and
large producers ($250 - 500,000+ in annual sales) make up 8% of all
farms, but receive 50% of government payments.
He said non-program crop farmers complained support
programs protect some crops more than others. Johanns said in 2005,
USDA spent $15.2
billion on program crops and less than $500 million on all other commodities
covered by price and income support programs. Put another way, 92%
of commodity program spending was spent on five crops – corn,
wheat, soybeans, cotton and rice. Two thirds of all farmers received
little support from federal programs.
In discussing the impact of the
on-going World Trade Organization (WTO) negotiations on U.S. farm bill
policy development, Johanns said the
U.S. must use the WTO to force open export markets for U.S. products,
but stressed “the WTO will not write our next farm bill.” Johanns also said the notion of a farm income “safety net” needs
to be examined. “A true safety net … is much more than
subsidies,” he said. “It is good farm policy that opens … substantial
market access. A true safety net is also good tax policy, trade policy,
sanitary and phytosanitary policies and investment in new markets.”
Return to top
Truck “Safe Food” Transport Authority Given To FDA
Tucked into the federal highway program reauthorization signed in
August by President Bush is the “Sanitary Food Transportation
Act of 2005.” This legislation shifts transport sanitation responsibility
to the Department of Health & Human Services (HSS) and expands
previously enacted law to ensure contract carriers hauling food are
taking the appropriate steps to ensure other shipments do not contaminate
food shipments.
In 1990, Congress enacted similar legislation after
a spate of media reports showed contract truckers delivering food to
supermarkets and
backhauling trash and, in some cases, garbage and other non-food loads.
This legislation instructed DOT to set rules for clean-out, backhauling,
etc., but DOT, claiming a lack of expertise, attempted to contract
with FDA to write the rules. FDA said it lacked the resources to take
on
the task. Finally, in 2004, DOT proposed a rule that said shippers
had to comply with applicable USDA and FDA rules.
The new law requires the Secretary of HHS to issue
rules setting up sanitary food transport practices that would bind
shippers, motor vehicle
and rail carriers, receivers and others engaged in land transport of
food and specifies that food shipped or offered for shipment that doesn’t
meet these rules would be considered adulterated. The rules would cover
sanitation, packaging, isolation and protective measures, limits on
vehicle use, information that carriers and shippers must disclose to
one another on food shipments and recordkeeping. The new law also
says DOT must consult with HHS and USDA to set up procedures for food
transport safety inspections that would identify contamination or adulteration
and cites conforming requirements under several meat and meat processing
laws.
Return to top
ITC Reverses Self on Canadian Wheat Board
The International Trade Commission (ITC) ruled October 6 that the
U.S. wheat industry is not injured by the Canadian Wheat Board under
the dumping and countervailing duty statutes, reversing a 2003 ruling.
Rep. Earl Pomeroy (D-ND) reacted to the ITC decision, saying, “This
decision is clearly wrong. The International Trade Commission has ignored
the obvious damage that our producers have suffered by the trading
practices of the Canadian Wheat Board. This goes to show that NAFTA
is flawed and is not adequately protecting the interests of our producers,
putting yet another hurdle in front of our family farmers.”
Return to top
Japan Cites Report as “Bright Outlook” for Beef Trade
with U.S.; EU Lifts Ban on T-Bone Steaks
An as-yet unfinished report done for the Japanese
Food Safety Commission is being touted by some Japanese officials as
offering a “bright
outlook” for Japanese resumption of beef trade with the U.S.
The report says the danger of BSE from U.S. beef is extremely low if
proper safeguards are followed, including that U.S. beef destined to
Japan must be from animals under 21 months old, that certain central
nervous
tissues must be removed, and that Japan-specific export inspection
criteria must be followed.
The Japanese statement comes as the call for increased
U.S. trade sanctions against Japan is picking up support in Congress.
Sen. Ben
Nelson (D-NE) said he was cautiously optimistic about news from Japan.
However, as the author of a successful Senate ag appropriations amendment
to stop USDA rulemaking that would allow high-end Japanese beef to
enter the U.S. unless the Japanese lift their ban on U.S. beef sale,
he’s
warned Japanese officials that other members are preparing legislation
to impose stricter trade sanctions on Japan.
Meanwhile, the European Union (EU) is reportedly about
to lift a restriction on beef-on-the-bone imposed as part of the EU’s
BSE restrictions. The action comes as the result of a European Commission
(EC) endorsement
of a draft proposal that would hike to 24 months the age limit for
removing the spinal column from cattle. The previous ban applied to
meat-on-the-bone cuts from animals over 12 months.
Return to top
Senate Ag $3-Billion Budget Reconciliation Plan
Unveiled; Battles Ensue
Sen. Saxby Chambliss (R-GA), chair of the Senate Agriculture
Committee, this week unveiled a bold five-year ag budget-cutting plan
to cut ag
spending by $3 billion. The plan would trim farm payments across the
board by 2.5%, hold back conservation spending by nearly $1 billion,
extend
but reduce payments under the Milk Income Loss Contract (MILC) program
so the program’s cost is $998 million and cut food stamps by
$574 million, among other actions.
Committee ranking member Sen. Tom Harkin (D-IA), joined
by some conservation, farm and nutrition groups, took shots at the
Chambliss plan, saying
to cut payments and programs when farmers “need help the most
is a double-dose of bad news for rural America.” Chambliss also
noted conservation programs were targeted for disproportionate cuts.
He said the cuts were part of a broader Republican plan to extend the
President’s tax cuts “for the most affluent Americans.” Chambliss
postponed a scheduled Oct. 7 markup of the budget plan.
The agriculture panel, like all authorizing committees
in Congress, is required under budget rules to bring program spending
into line
with the congressionally mandated budget resolution that sets an overall
federal spending ceiling for government operations. Agriculture’s
share of this reconciled spending reduction is $3 billion and Chambliss
stressed, “This committee is still required to choose where $3
billion in five-year deficit reduction cuts will come from.”
On conservation spending, the Conservation Reserve
Program would be cut $129 million and the Conservation Security Program
would be limited
to $2 billion and would limit its overall budget to $5.2 billion through
FY2015. The Environmental Quality Incentive Program (EQIP) would take
a $104 million hit and the plan would cut $227 million out of ag research
programs.
Return to top
Doha Reps Begin Talks About Specific Subsidy Cut Numbers
Hoping to hammer out an agreement on how much developed
and developing nations will cut trade-distorting farm subsidy programs
before the
Doha Round ministers meeting in December, the U.S. this week proposed
to WTO members at a meeting in Geneva a tariff reduction formula that
would divide current tariffs on ag products into four tiers, with higher
reductions on the higher tariffs. Developing countries also would
be subject to the four tiers, but with smaller cuts required. The U.S.
also proposed that “sensitive products” such as sugar
be shielded and enjoy longer periods for tariff cut implementation.
The European Union (EU) meanwhile proposed cutting
its own domestic subsidies by 65%, saying Japan should do likewise
and the U.S. could
cut its trade-distorting payments by 55%. The EU also insisted that
the U.S. cut its food aid shipments and that Australia, New Zealand
and
Canada curtail actions by their state trading enterprises.
Return to top
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.1821
Sen. Harry Reid (D-NV) proposed a bill to increase preparation for
an influenza pandemic, including an avian influenza pandemic.
S.1822
Legislation introduced by Sen. Patty Murray (D-WA) would make improvements
to the implementation of the Medicare prescription drug benefit.
S.1833
Sen. Mike Crapo (D-ID) proposed a bill to provide for health opportunity
accounts under the Medicaid Program.
S.1840
Sen. John Thune (R-SD) introduced legislation to increase the affordability
of inpatient drugs for Medicaid and safety net hospitals.
S.1841
A bill offered by Sen. Bill Nelson (D-FL) would provide extended and
additional protection to Medicare beneficiaries who enroll for the
Medicare prescription drug benefit during 2006.
H.R.3969
Rep. Roy Blunt (R-MO) offered a bill to designate a USDA disaster liaison
to assist its state and local employees in coordination with other
disaster agencies in responding to federally declared disasters.
H.R.3974
Rep. Frank Lucas (R-OK) proposed legislation to prohibit the closure
or relocation of county or local Farm Service Agency offices pending
the completion of the next omnibus agriculture law.
H.R.3998
A bill offered by Rep. Cynthia McKinney (D-GA) would provide farm debt
and program relief to African-American farmers who suffered discrimination
in the administration of USDA farm credit programs and other agriculture
programs.
H.R.3980
Rep. John Dingell (D-MI) introduced legislation to improve the qualified
Medicare beneficiary (QMB) and specified low-income Medicare beneficiary
(SLMB) programs within the Medicaid Program.
H.R.4009
Legislation proposed by Rep. Bennie Thompson (D-MS) would direct the
Secretary of Homeland Security to conduct comprehensive examinations
of the human resource capabilities and needs, organizational structure,
innovation and improvement plans, intelligence and information analysis
capabilities and resources, infrastructure capabilities and resources,
budget, and other elements of the homeland security program and policies
of the United States.
Return to top
Inside
Track is produced as a service to clients of Policy Directions,
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