Crawford Nomination Hits Speed Bump
As promised at his nomination hearing before Senate
Health, Education, Labor & Pensions (HELP) Committee, FDA Commissioner-designate
Dr.
Lester Crawford met with interested committee members on April 6 to
further respond to concerns about FDA’s handling
of an application to move the so-called “morning after pill” Plan
B to over-the-counter (OTC) status. At the hearing, Crawford responded
this application has taken longer than some might have expected because
it has “unique” aspects. Several committee members wanted
further information about what was “unique” about the application,
as well as the agency’s timeframe for a decision.
Among those attending the meeting with Crawford, Sens.
Patty Murray (D-WA) and Hillary Clinton (D-NY) were dissatisfied with
information
they received and placed “holds” on Crawford’s
nomination. This action is taken when Senators want to slow down, or
stop altogether, Senate action. Murray and Clinton
indicated they want better answers about Plan B before they will support
Crawford’s appointment.
Crawford reportedly indicated at yesterday’s
meeting the agency remains concerned about who will use Plan B if available
OTC and why it will be used. Further, he is said to have indicated,
as he did at the earlier hearing, that a pending lawsuit is slowing
agency action while decisions are being made about how this will be
dealt with.
Meanwhile, the HELP Committee posted a notice that
it will meet on April 13 to consider the Crawford nomination. How the
nomination
will fare at the committee or when and how the Senate subsequently
will proceed is unclear.
Return to top
FDA Takes Further Action on COX Drugs
Following on the heels of a three-day advisory committee
meeting in February focusing on the relative risks and benefits of
COX-2 and non-steroidal
anti-inflammatory drugs sold both by prescription and over-the-counter
(OTC), FDA Thursday announced a number of dramatic
changes.
First, the agency has reached an agreement with Pfizer
to remove Bextra from the market, making this the second COX product
withdrawal in less than a year. (VIOXX was removed from the market
by Merck in September, 2004.) When it considered Bextra specifically,
the FDA advisory committee voted 32-0 that the product significantly
increased cardiovascular risk, but 17-13 that the overall risk-benefit
profile
supported continued marketing of the drug. Among the advisory committee’s
recommendations was increased and more prominent (Black Box) warning
labeling on the product. The committee did not specifically recommend
product withdrawal.
Further, FDA will require Black Box warnings on Celebrex and all prescription
non-steroidal anti-inflammatory drugs (NSAIDs), and revised labeling
on all OTC NSAIDs. The new labeling will provide more information about
potential cardiovascular and gastrointestinal risk.
In addition to a press release and talk paper, FDA also issued a Public
Health Advisory and provided new fact sheets for patients and providers
regarding these products and decisions.
These actions come as FDA continues to be criticized by some on Capitol
Hill and in the consumer advocacy community for not being aggressive
enough on drug safety. Public Citizen, in fact, while applauding removal
of Bextra from the market, continued in its public statements to call
for more action. “While we are pleased that the FDA has taken
Bextra off the market, it has recklessly allowed Celebrex to continue
to be sold,” the organization stated. “We call on Congress,
which is finally delving into FDA’s operations, to investigate
why the agency is not also pulling the equally dangerous Celebrex from
the shelves.” FDA, in its Public Health Advisory, states the
agency’s conclusion that “the benefits of Celebrex outweigh
the potential risks in properly selected and informed patients.”
Return to top
Implementation of Full NIH Ethics Rules Slowed
National Institutes of Health (NIH) Director Elias
Zerhouni said he is delaying implementation of the requirement in the
new ethics guidelines that force employees who hold stock in drug or
medical companies to divest their stock.
Appearing Wednesday before the Senate Appropriations subcommittee on
Labor, HHS, & Education Zerhouni reiterated his strong support
for the new rules' ban on consulting with any drug, biotech or medical
devices company, or any institution doing substantial business
with NIH. Yet he also acknowledged that restrictions on stock ownership
have alienated NIH employees, led to the resignations of high-level
administrators and delayed the appointment of a new NIH official.
"That part of the rule, frankly, is the one I
think we need to re-evaluate very quickly," Zerhouni told the
Senate panel. Among Senators who said the rules went
too far were Sens. Arlen
Specter (R-PA) and Tom Harkin (D-IA).
In one instance, James F. Battey, chief of NIH's human-stem-cell program
and director of that agency's deafness institute, cited the rules in
announcing his retirement, and David Schwartz, a physician from Duke
University, has postponed taking the helm of the National Institute
of Environmental Health Sciences.
The Washington Post has been covering the
new ethics rules closely with coverage of the chilling effect the new
rules are having on the
scientific community. For instance, under the new rules, many NIH employees
cannot hold executive positions with trade or professional organizations,
even on a volunteer basis, because those groups often represent scientists
who could be grant recipients. They also cannot accept awards or prizes
of more than $200. The Post went further in an editorial appearing
in Wednesday’s edition criticizing the rules for being “overbroad,
intrusive and unnecessarily punitive.”
Return to top
HELP Committee Announces Importation
Hearing
Fulfilling a commitment made earlier this year to
Sen. Byron Dorgan (D-ND), the Senate Health, Education, Labor & Pensions
(HELP) Committee
will hold a hearing on Dorgan’s prescription drug importation
bill, S. 334. The committee has held two hearings on Rx importation,
one focusing on the Surgeon General’s report regarding safety,
and a second focusing on a Commerce Department report on cost. At neither
hearing were specific legislative provisions discussed.
The upcoming hearing, scheduled for the week of April
18, will respond to Dorgan’s request, made in the context of
the Senate’s
moving forward with the nomination of Gov. Mike Leavitt to be Secretary
of Health & Human Services, was to have the committee and witnesses
talk specifically to provisions of proposed legislation, particularly
his bill. S. 334 has 30 cosponsors, of whom four (Sens. Ted Kennedy
(D-MA), Jim Jeffords (I-VT), Hillary Clinton (D-NY), and Jeff Bingaman
(D-NM)) are members of the HELP Committee. S. 334 is not the only Rx
importation bill to be introduced in this Congress, and Enzi has
indicated his own interest in working in a bipartisan fashion on the
issue.
Return to top
Broader Stem Cell Access to Receive House
Floor Vote
House Republican leadership told party moderates a vote will
occur before August on a proposal to modify President Bush's stem cell
research policy. Rep. Mike Castle (R-DE) said the leadership pledged
to take up some version of a proposal to allow federally financed research
on stem cells taken from leftover frozen embryos from fertility clinics.
Under the current policy set by President Bush in 2001, federal financing
is only available for a finite number of stem cell lines. A bill introduced
by Castle and Rep. Diana DeGette (D-CO) would allow for the use of
leftover embryos from fertility treatments with the permission of the
couple. In an attempt to tackle the ethical questions surrounding embryonic
stem cells, the members argue these embryos have already passed the
point where a decision has to be made between life and destruction.
Castle said his proposal strikes a balance between the
benefits of research using existing stem cell lines and reluctance
to create a potential human life solely for laboratory use.
While House leadership promised a vote on the issue, it is unclear
whether it will be on the Castle/DeGette bill. A Senate version of
the bill has been introduced by Sen. Arlen Specter (R-PA), but Majority
Leader Sen. Bill Frist (R-TN) has not indicated plans to bring it up
for a vote. The White House continues to oppose any changes to the
current ban.
Return to top
Obesity and Nutrition Addressed at House Hearing
Addressing obesity and nutrition issues, the House Appropriations
subcommittee on Agriculture held a hearing on Research, Education and
Economics (REE) on Thursday.
Joseph J. Jen, USDA Under Secretary for Research, Education and Economics,
testifying at the hearing, stated “Particularly disquieting is
the incidence of obesity in children, estimated to be approximately
15 percent and essentially doubling between 1980 and 2000 ... USDA,
with its food assistance, nutritional education, and nutrition research
programs, plays an important role in promoting healthy nutrition and
weight, in general, and in addressing the obesity challenge, in particular.”
Rep. Sam Farr (D-CA) asked what the Agricultural Research Service
(ARS) and USDA are doing to increase fruits and vegetables in schools.
He also said that they are moving too slow and need to put their money
where their mouths are. Jen responded that over the past year the department
has worked to raise the importance of obesity, particularly prevention.
Research into human nutrition has occurred and they have brought different
disciplines together to create an integrated program. He noted that
greater understanding is needed because we know that most people have
the choice of eating fruits and vegetables, but don’t.
Edward B. Knipling, USDA Administrator for ARS, added that the Human
Nutrition Centers are doing work on these issues and the release of
the Dietary Guidelines emphasizes fruits and vegetables. He noted significant
funds, 15% of the ARS budget, goes to basic core plant research, with
human nutrition at 8% of the budget in six centers (35% of the budget
is for plant science). Farr questioned why only 15% is spent on this
research and requested a complete breakdown of the 35% figure including
general and sub categories. In addition he asked for raw evidence showing
if any of the money is helping the fight against obesity.
The six person panel also included Colien Hefferan, Administrator,
Cooperative State Research, Education and Extension Service, Susan
E. Offutt, Administrator, Economic Research Service, R. Ronald Bosecker,
Administrator, National Agriculture Statistics Service and Dennis Kaplan,
USDA Budget Office.
Return to top
FDA Publishes Food Labeling
Notices
On April 4, FDA published two Advance Notices of Proposed
Rulemaking deriving from earlier recommendations of the agency’s
Obesity Working Group. The Working Group, established in 2003, issued
a final report with recommendations in February 2004, after holding
a number of workshops and public meetings and collecting comments through
a public docket.
The notice entitled “Food Labeling: Prominence
of Calories” requests comment on how the food label could be
improved to provide more useful information to consumers about food
calorie content. The notice raises a number of questions, asking commenters
to respond and provide suggestions related to the Obesity Working Groups’ recommendations
to consider giving more prominence to calorie content on the food label,
presenting calorie information in ways other than, or additional to,
percent daily value or percent relative to fat. The notice also asks
about possibilities for reformulating food products to reduce calorie
content.
“Food Labeling: Serving Sizes of Products that
Can Reasonably Be Consumed At One Eating Occasion; Updating of Reference
Amounts Customarily Consumed; Approaches for Recommending Smaller Portion
Sizes” requests comment on revising the food label to provide
more sensible and understandable information about serving size. Among
issues raised by the Obesity Working Group was packaging more than
one serving in small containers or bags that consumers generally would
believe constitute a single serving (such as a snack pack of potato
chips). The Working Group said consumers may not make the connection
between label information about calories, fat in a single serving and
that if they eat the whole bag, they are actually consuming two or
more servings and thus twice or more times calories.
FDA indicated it is asking for comments and suggestions,
not proposing solutions, because the agency wants input from industry
and consumers about the best ways to proceed on these matters. There
is a 75-day comment period for both notices with a June 20, 2005, deadline.
Return to top
CMS Publishes Draft Guidance on “Coverage
with Evidence Development”
On April 7, the Centers for Medicare & Medicaid
Services (CMS) published a draft guidance on its approach to National
Coverage Decisions in the course of gathering additional evidence of
the medical benefit of a service or product. The guidance lays out
the argument that patient access to new technology, or existing technology
used for new purposes, can be enhanced by allowing for coverage while
evidence of benefit is being gathered. In cases where additional evidence
is needed, CMS says, coverage could be provided so long as certain
conditions are met that involve prospective collection of data.
Just as in cases where coverage is limited to specific
individuals with certain conditions or characteristics that make them
more likely to benefit or to specific providers, coverage “under
protocol” could be limited to cases where patients and providers
are participating in a defined data collection activity, such as a
clinical study or registry.
CMS indicates that while coverage decisions generally
have fallen into categories of coverage denied, coverage with conditions,
or coverage without conditions, the agency does not anticipate any
national coverage decisions in the future that will not be associated
with some pre-defined conditions.
As its authority to proceed with this concept, CMS
cites provisions of the Social Security Act stating Medicare coverage
is provided for items and services that are “reasonable and necessary.” Determining
whether it is reasonable or necessary, the guidance states, requires
either sufficient evidence already available that a medical benefit
is generally derived from the service or by specific patients, or continued
collection of information to make such a demonstration. As an example,
the Guidance cites off-label use of cancer drugs where use is not cited
in a medical compendium. Recently, a decision was made to cover such
off-label use provided the patients enrolled in specified clinical
studies.
The publication requests comment on a number of aspects
of this Coverage with Evidence Development (CED) process, although
does not appear to suggest there is a possibility that the CED process
will not move forward. Interested parties are asked to comment on a
number of items, including appropriate circumstances for a CED, process
for requesting such a coverage determination, various approaches to
collecting evidence, what kinds of evidence will be most useful and
realistically obtainable and what is the universe of affected stakeholders.
Written comments are due to CMS by June 5, 2005 with an Open Door Forum
scheduled for May 9, 2005.
Return to top
Bond Introduces Bill to Modernize Mississippi
Lock System
Saying the legislation is key to jobs creation and
economic development along the upper Mississippi River, Sen. Christopher “Kit” Bond
(R-MO) this week introduced legislation to modernize the river locks
and dams system.
Bond was joined on the bill, part of the Water Resources Development
Act (WRDA), by Sens. Jim Talent (R-MO), Chuck Grassley (R-IA) and Tom
Harkin (D-IA), but the bill is expected to garner support from a bipartisan
group of Senators whose states rely on Mississippi River transport
to move agricultural and manufactured commodities to ports on the Gulf.
The bill would authorize $2.475 billion for seven new locks, including
$1.58 billion for ecostystem restoration. The money would be used to
replace the aging infrastructure, and is predicted to create 48 million
man-hours of construction work.
The current system is nearly 70 years old, Bond said, and in the last
35 years water-borne transportation has more than tripled to over 85
million tons.
Return to top
Groups
Push for Low Level Antibiotic Ban in Feeds
Groups opposed to the use of low-level antibiotics
in livestock and poultry feed delivered a one-two punch to the industry
this week
with the introduction by Sens. Edward Kennedy (D-MA), Olympia Snowe
(R-ME) and Susan Collins (R-ME) of a bill to phase out seven classes
of antibiotics used in human medicine, action that followed the filing
of a petition with FDA to achieve the same goal.
While the public reason for the bill and the petition is concern over
antibiotic resistance, the Animal Health Institute (AHI) said the action “was
nothing new” for the activist groups, and reiterated its position
that there is no verifiable science to substantiate the activist claim.
At the same time, AHI said, to remove the products will result in animal
sickness and death, while adversely affecting farmers’ income
and food quality and availability.
The petition was filed by Food Animal Concerns Trust
(FACT), an animal rights group, Environmental Defense, Union of Concerned
Scientists,
American Public Health Assn. and the American Academy of Pediatrics.
Industry also points to the same set of FDA guidelines as the activists
when saying there’s no reason to ban the products. The agency
is reviewing the use of some products as growth promoters.
Return
to top
Europe to Leave Syngenta Inquiry
to the U.S.
European officials this week said they will leave
to the U.S. the investigation into how Syngenta’s unapproved
genetically modified corn seed got into the market and eventually was
sold as product
in the European
Union (EU). The European Commission estimates about 1,000 metric tons
of animal feed, corn flour and corn oil entered the EU. The Commission
has also written an “open letter of protest” to Syngenta
asking for its cooperation in tracking down suspect products, a spokesman
said, but added that beyond that action, “it’s a matter
for U.S. authorities.”
Return to top
Harkin Calls for Investigation into
Livestock Concentration
Renewing the Iowa Senate call of the last three Congresses, Sen. Tom
Harkin (D-IA) this week said a “rapidly consolidating livestock
industry” calls for an investigation of how USDA is carrying
out its responsibilities under the Packers & Stockyards Act. It’s
this law that prevents anti-competitive, unfair and deceptive practices
in the livestock and poultry markets.
Harkin sent a letter asking USDA’s Inspector General to look
into how aggressively and accurately USDA is examining and reporting
anti-competitive and unfair market practices.
“In Iowa and across the country, many of our family-sized livestock
producers are disappearing as large, corporate, vertically integrated
operations grow. This trend is very disturbing and lack of attention
given to this issue by USDA is unacceptable,” said Harkin in
his letter.
Return to top
Conner Confirmation Hearing as USDA
Deputy Secretary Goes Smoothly
The confirmation hearing this week for White House ag guru Chuck Conner
to be deputy secretary of agriculture went smoothly, with Senate Agriculture
Committee members from both sides of the aisle praising Conner. At
the same time, Conner, currently special assistant to the President
for food, agriculture and trade policy, pledged to be the “reconciliation
person” between Congress and the Bush White House on ag budget
issues.
Conner is former staff director of the Senate Agriculture Committee
under Sen. Richard Lugar (R-IN), and was a long-time Hill staffer.
Sen. Saxby Chambliss (R-GA), committee chair, told Conner he had “no
dialogue” with the Bush White House during budget discussions
following the President’s recommendation that the ag budget be
cut by billions. Several members of the panel also cited the budget
cuts as a major bone of contention, but Conner defended budget trimming
as the only way to maintain the financial success of agriculture.
Sen. Max Baucus (D-MT) called Conner’s statement about the wellbeing
of agriculture use of “the tyranny of averages,” saying
there are several pockets of financial trouble throughout rural America.
Other issues brought to Conner’s attention included improving
locks and dams on the Mississippi River, the purchase of bio-based
products by the federal government, and quick resolution to GATT trade
disputes.
Return to top
ITC Goes Against Pork Producers; Canada to Hit U.S. with Tariff
on Hogs
The International Trade Commission (ITC) this week ruled 5-0 against
the National Pork Producers Council (NPPC), saying U.S. producers
are not being injured by Canadian live hog imports. At the same time,
the Canadian government announced it will impose a 15% tax on live
hogs, some fish products and cigarettes imported from the U.S. beginning
May 1.
The ITC vote followed an affirmative finding by the U.S. Department
of Commerce that Canadians were dumping live hogs in the U.S. market,
but Commerce refused to impose a countervailing duty. U.S. producers
contend Canada is dumping thousands of hogs into the U.S. market,
animals raised on “generous federal and provincial subsidies.”
The Canadian action comes as a result of the World Trade Organization’s
(WTO) decision in August that the U.S. Byrd Amendment is an unfair
subsidy, clearing the way for affected countries to apply trade sanctions.
The Byrd Amendment provides for the annual distribution of collected
antidumping and countervailing duties to "affected domestic
producers” to defray damages. An "affected domestic producer" is
defined as a manufacturer, producer, farmer, rancher, or worker representative,
including associations.
Return to top
BSE UPDATE
Taiwan Reopens Market
to U.S. Beef; Canada Gets OK from Cuba
As expected, the government of Taiwan this week announced it is
lifting its ban on U.S. boneless beef from animals under 30 months
of age, effective April 16. Taiwan was a $76-million market for U.S.
beef in 2003. At the same time, the Cuban government announced it
will resume purchasing live cattle from Canada, following last December’s
decision to start buying beef and beef products. Tunisia and Lebanon
have also begun buying Canadian beef, officials said.
Return to top
Japanese Government, Consumers in Beef Over U.S. Exports
While the Japanese government continues to grind slowly through
its regulatory process along with its umpteenth review of agreed-to
animal testing procedures, nearly 1.2 million Japanese consumers
submitted a petition to the Japanese Ministry of Agriculture this
week demanding the government drop its ban on U.S. beef imports.
“We want U.S. beef back so we can enjoy dishes like gyu-don
(beef and rice) and barbecued tongue,” said a petition drive
spokesman. “Americans are eating U.S.-grown beef with confidence
about its safety – then why can’t we? American beef tastes
good, almost like homegrown beef.” Reports indicate U.S. beef
is important to restaurants which serve such low-cost dishes as they
use parts of the animal that are cheap to import.
Return to top
Japan Confirms 17th Case of BSE
Another Holstein cow has been diagnosed with BSE in Japan, bringing
to 17 the number of cases confirmed in that country. The four-and-a-half
year-old cow was kept in Otofuke, Hokkaido, and was born in 2000,
the year before the Japanese imposed their feed ban.
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.729
Sen. Richard Durbin (D-IL) introduced a bill that would establish the
Food Safety Administration to protect the public health by preventing
food-borne illness, ensuring the safety of food, improving research
on contaminants leading to food-borne illness, and improving security
of food from intentional contamination.
S.742
A bill offered by Sen. Olympia Snowe (R-ME) would amend the Federal
Food, Drug, and Cosmetic Act to preserve the effectiveness of medically
important antibiotics used in the treatment of human and animal diseases.
H.R.1507
Rep. Rosa DeLauro (D-CA) introduced legislation that would establish
the Food Safety Administration to protect the public health by preventing
food-borne illness, ensuring the safety of food, improving research
on contaminants leading to food-borne illness, and improving security
of food from intentional contamination.
Return to top
Inside
Track is produced as a service to clients of Policy Directions,
Inc., a Washington, DC-based government relations/strategic government
communications firm founded in 1995, specializing in customized
advocacy on health care; food; biomedical research; biotechnology,
human drug, and medical device regulation; federal nutrition policy
and programs; and environmental policies and programs. For more
information about PDI, please e-mail info@poldir.com.
All material © 2005 Policy Directions.
|
