Appropriations Bill Includes Trade Agreement Provisions Affecting Prescription
Drug Importation The House and Senate agreed in
conference to include in the FY 2006 appropriations bill for Science & the
Departments of Commerce, Justice & State
restrictions on certain aspects of negotiating new trade agreements. First
introduced as an amendment in the House Appropriations Committee by Rep. Anne
Northup (R-KY), the provision is intended to preclude the U.S. Trade Representative
from incorporating in future trade agreements language to prevent
prescription drug importation. The prohibition was offered to the appropriations
bill in
the Senate by Sen. Debbie Stabenow (D-MI) and others.
In her remarks about the amendment, Northup said prescription drug importation
is “gaining steam” in Congress and opponents are therefore looking
for “more creative road blocks.” Language in trade agreements,
she said, is one such road block. The amendments cite recent free trade agreements
with Australia, Singapore, and Morocco, which include language that effectively
prevents importation of prescription drugs by giving the prerogative to U.S.
patent holders to prevent importation of their products. According to proponents
of the amendment, the U.S. would, without this language, include similar prohibitions
in all future trade agreements.
Specifically, the appropriations bill language prohibits the use of appropriated
funds “to include in any new bilateral or multilateral trade agreement” the
relevant language from the agreements with Australia, Singapore, and Morocco.
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White House Avian Flu Bill Facing Questions from Key House Members
The White House $7.1-billion plan to help the U.S. prevent
an avian influenza hit Capitol Hill this week. Some House members scurried
to broaden
the incentives and protections in the package, while others outright questioned
the need for a multi-billion-dollar bird flu program. All agree some form of
incentive is necessary for vaccine manufacturers, as well as some kind of liability
protection, but the breadth of the program and whether it should be part of
other biosecurity measures now pending is the question.
House Appropriations Committee Chair Rep. Jerry Lewis (R-CA) introduced his
own legislation that would extend the Administration scheme to other companies
involved in biosecurity component development.
On November 8, HHS Secretary Mike Leavitt testified before
the House Energy & Commerce
Committee, expanding on matters regarding the Administration’s plans.
Noting the real threat of pandemic flu, Leavitt said the Administration’s
request for over $7 billion is intended, among other things, to provide for
the production of enough vaccine for every American within six months of the
outbreak and enough drugs and other medical supplies for 25% of the U.S. population.
Citing liability concerns as a hurdle to expanding the vaccine industry, Leavitt
said the Administration has proposed liability protections for vaccine manufacturers
and providers, except in cases of “willful misconduct.”
Expressing some skepticism about the large sum of money being requested, Committee
Chair Joe Barton (R-TX) said he intends to look closely at what is being proposed
so as not to waste taxpayers’ money. Wasting money, he said, “will
not keep people from catching the flu.” He also said enactment of
Bioterrorism legislation already was a step toward preparedness, as are provisions
of the Bioshield legislation that provide incentives to companies to develop
countermeasures. While Barton has met with Lewis, he said he also wants to
work with the White House. In subsequent public statements, however, Barton
indicated he does not support the Administration’s emergency budget request
and probably will not vote for it.
Other committee members also expressed concerns about
the flu plan, including highlighting that the plan’s request for state
funds is insufficient and states are ill-prepared in multiple ways to respond
effectively to a pandemic.
The House Agriculture Committee will hold a hearing on bird flu preparedness
November 16.
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GAO Makes Recommendations About Controlling Illegal Drug Imports
In response to a request from Sen. Norm Coleman (R-MN), chair
of the Senate Homeland Security & Governmental Affairs permanent subcommittee
on investigations, and Rep. John Dingell (D-MI), ranking Democrat on the House
Energy & Commerce
Committee, the Government Accountability Office (GAO) issued a report, released
Thursday, entitled “Strategic Framework Would Promote Accountability
and Enhance Efforts to Enforce the Prohibitions on Personal Importation.” The
GAO evaluated information on the volume of illegal prescription drug importation,
potential safety issues with imported products, and how federal agencies are
working to address the issue.
The report acknowledges the difficulty of getting precise information about
either safety or numbers, but emphasizes the view of both FDA and the Customs & Border
Patrol Agency (CBP) that the volume of illegally imported drugs is increasing.
The sheer and increasing numbers, GAO says, strain agency resources, making
enforcement extremely difficult. Further complicating the matter, many products
are ordered over the Internet from organizations outside of the regulatory
jurisdiction of U.S. agencies. Further, they bypass the legal requirement that
FDA notify addressees and give them an opportunity to submit evidence that
the products are legally allowed to enter the U.S. This was identified by FDA
as an especially difficult hurdle and one the agency needs to consider if it
recommends legislative changes that could help its enforcement efforts.
In addition to talking with agency representatives, GAO also spoke with credit
card companies and visited mail and common carrier facilities to achieve an
understanding of how the current system is functioning and what can be done
through the private and public sector actions.
GAO recognizes in the report actions to try to improve agency
coordination and effectiveness, particularly in regards to Internet drug sales,
but argues
these efforts are not likely to be sufficient. The bottom line of GAO’s
evaluation and report, however, was no crisp “final answer” to
the burgeoning problem. The report includes only two recommendations: (1) that
the agencies involved in the recently established CBP task force (including
FDA, DEA and the postal service) “establish a strategic framework to
enhance their enforcement efforts” and (2) that FDA and HHS should “assess
the effect of modifying” FDA’s legal requirement to notify addressees
regarding the possible illegal status of packages of prescription drugs being
mailed or shipped to them.
Return to top Government Reform Chair Slams FDA’s Response on Steroids in Dietary
Supplements
House Government Reform Committee Chair Tom Davis (R-VA) issued a statement
Thursday expressing disenchantment with a response he received from FDA to
his request the agency look into allegations that certain dietary supplement
products contain steroids not listed among their ingredients. A letter Davis
sent to FDA October 21 had asked the agency what it was doing to investigate
charges that certain dietary supplements tested positive for so-called “designer
steroids.” The letter referred to an October 18 article in the Washington
Post, reporting that when it had five performance-enhancing or muscle-building
supplements tested, they all contained steroids not listed on their labels.
The committee letter asked FDA not only to look into these
products but, more generally, what it is doing to ensure supplements containing
steroids
are not on the market, how it is monitoring supplements and supplement labeling,
when supplement Good Manufacturing Practices (GMPs) will be published, whether
adverse event reports have been submitted to FDA, and what actions have been
taken
in cases where there are problems.
FDA’s response provided general background information
on the Dietary Supplement Health & Education Act of 1994 (DSHEA) and FDA’s
regulatory authorities, as well as a brief description of interactions between
the agency
and laboratories that tested the products mentioned in the Post article.
FDA indicated the agency is collecting evidence and will pursue enforcement
action
against the products’ manufacturers as appropriate. The letter also noted
that FDA’s limited resources make setting enforcement priorities essential
and that the large increase in dietary supplement products since enactment
of DSHEA makes it difficult or impossible to track all the products and/or
new ingredients. The agency also offered to provide a briefing for the committee
if further details are needed.
Stating he would “prefer a late but substantive response opposed to
an inadequate prompt one,” Davis said the agency must provide specific
responses to “help us turn back this rising tide” of steroid use
by young people.
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Grassley Asks IG to Look at Clinical Trials
In a letter to the HHS Inspector General November 8, Sen.
Charles Grassley (R-IA), chair of the Senate Finance Committee, asked the Office
of the Inspector
General (OIG) to look into reports that clinical trial oversight, including
by institutional review boards (IRBs), is not sufficient to protect patients.
Grassley was responding to a recent report in Bloomberg Markets charging that
those charged with protecting patients in clinical trials are not doing their
jobs and, as a result, many patients are being injured or dying. The report
alleges problems with, among other things, improper patient informed consent,
lack of regulation of IRBs, failure of IRBs to oversee and monitor trials properly,
and poorly trained and unlicensed clinical investigators.
Grassley asked the OIG to determine what, if any, legislative
or administrative actions are needed to improve clinical trial oversight and
to forward to him
a list of all the recommendations regarding clinical trials and IRBs the OIG
has made over the last 10 years. He noted he also is asking for information
from NIH, FDA and HHS regarding actions they have taken in response to OIG
recommendations in reports dated 1995, 1998, 2000 and 2001. Finally, Grassley
asked the OIG keep him up to date on activities in this area and provide him
with a briefing as soon as possible. “We must,” he says, “take
every possible step to ensure that our clinical trial system is in fact the ‘gold
standard’ that we expect it to be.”
Return to top Child Medication Safety and Methamphetamine Bills on House Floor
Following the long Veteran’s Day weekend, the House expects to take
up a number of bills, including two healthcare related provisions.
Rep. John Kline (R-MN) introduced the “Child Medication Safety Act of
2005,” H.R.1790, which would require states, as a condition of receiving
federal education funds, to develop and implement policies and procedures prohibiting
school personnel from requiring a child, as a condition of attending school
or receiving services, to obtain a prescription for a controlled substance
or a psychotropic drug.
However the bill, introduced on April 21, does not create
a federal prohibition against school personnel consulting or sharing classroom-based
observations
with parents or guardians regarding a student's academic performance or behavior
in the classroom, or regarding the need for evaluation for special education
services under the Individuals with Disabilities Education Act (IDEA).
Also scheduled for the floor is the “Methamphetamine
Epidemic Elimination Act” H.R. 3889, sponsored by Rep. Mark Souder (R-IN), would prohibit
unlimited sales of pseudoephedrine and other meth precursor chemical products,
as well as authorize limits on the amount of pseudoephedrine and similar products
that can be manufactured or imported.
In addition, the bill would amend the international drug certification process
to require federal reporting on major exporting and importing countries of
precursor chemicals, require the State Department to work with the Mexican
government in new efforts against meth producers and traffickers, and authorize
enhanced penalties for meth smugglers. The bill also addresses environmental
concerns by strengthening regulations and penalties against meth traffickers
who pollute the environment.
Introduced in September, the House judiciary subcommittee
on crime, terrorism and homeland security held a hearing on the bill. The full
committee reported
the bill November 9.
Return to top USDA Raises Corn, Bean Estimates
as Harvest Piles Up; Farm Income Expected to be Second Highest Ever in Face
of Energy Cost Spike
U.S. corn production is estimated to be 11.032 billion bushels this
year, up from the previous low-end estimate of 10.818 billion, but
still lower than last season’s 11.807 billion, USDA reported
this week. Soybean production is estimated at 3.043 billion bushels,
up from expectations, but again, slightly below last year’s harvest.
At the same time, U.S. net farm income is expected to hit $71.5 billion
for 2005-2006, the second highest ever and below last year’s
record $82.5 billion. The drop is attributed to rising energy-based
input costs, including fuels, fertilizer and crop inputs.
Even with optimistic crop reports from USDA, reports are increasing
about corn and beans piled on the ground throughout the Midwest in
the wake of record yields, lower crop prices, high energy and transport
costs and the impact of hurricanes on the Port of New Orleans. Experts
say stockpiling was inevitable as farm production efficiency advances
while commercial, processing and feed plant storage and commercial
transportation capabilities have not kept pace.
USDA announced it will begin accepting competitive bids from industry
for a targeted program to speed up barge unloading, part of a plan
to free up barge transport on the Mississippi River. While the department
has $7.6 million for the program, it said it will not accept bids
over $30 per ton, the current barge freight rate. USDA said it wants
to move empty barges quickly to harvest areas, and while there are
no restrictions on off-load location, final destination or disposition
of the commodities involved, USDA said there must be no negative
market impact.
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Ag Issues Continue to Stall WTO Talks
U.S. officials this week confirmed World Trade Organization (WTO)
negotiators hit an impasse over subsidy reductions, market access and
tariff reform. The immediate cause, observers say, is the refusal by
the European Union (EU) to up its offer to cut subsidies and increase
its relatively low offer on tariff reductions. The EU contends refusals
by India and Brazil to talk nonagricultural and service market access
is the real stumbling block.
The roadblocks on ag issues threaten to derail next month’s
Hong Kong ministers meeting. Nations like Brazil, which has been pushing
for greater access by low-income countries to richer nations’ food
and ag markets, said without agreements on farm issues, there’s
no reason to discuss reforms in manufacturing, finance or service areas.
U.S. Special Trade Representative Rob Portman, in
a joint presentation with Secretary of Agriculture Mike Johanns, stressed
the Hong Kong
ministerial meeting is not the end of the road on WTO discussions,
but a “milepost” given the deadline for a deal is December
2006. Some insiders say if the December meeting goes poorly, there
is hope the EU may come back to the table in the spring with a more
generous offer. Others say France, which is dead set against opening
European markets to global competition, will stymie such a move.
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House GOP Leadership Pulls Budget Reconciliation Bill as “Moderates” Rebel
on Cuts, ANWR; President Signs Ag Appropriations Bill
In the face of mounting rebellion by GOP moderates seeking restoration
of some planned budget cuts and demands by conservatives to hold the
line on spending, House GOP leadership pulled from consideration the
House version of budget reconciliation this week. At issue were several
cuts, including controversial Medicaid savings and cuts in the federal
food stamp program included in the ag spending cuts. The House is expected
to take up the bill again next week. The Senate passed its $35-billion
package of spending cuts last week.
Several changes to the House reconciliation package
were accepted by leadership in a last-ditch effort to get floor approval
of the bill.
The House Rules Committee relaxed the cuts to foods stamps by allowing
for exemptions for legal immigrants who are disabled, elderly or who
have applied for citizenship and dropped controversial language that
would allow oil drilling in the Arctic National Wildlife Refuge and
on the outer continental shelf.
Meanwhile, the President November 10
signed into law the FY2006 ag/FDA appropriations bill, bringing to
four the number of spending packages
now completed. The bill includes only slight increases in spending
for this fiscal year. Sen. Conrad Burns (R-MT) released a statement “scolding” Congress
for the ag spending package. He explained he voted against it because
it carries language delaying country-of-origin labeling (COOL) for
fresh meats for two years and the COOL language received neither debate
nor a vote in conference committee action. Return to top
House Limits Eminent Domain
The House gave back to private property owners protections
struck down by the Supreme Court earlier this year when it passed a
bill that
would restrict government’s use of eminent domain to seize private
property for economic development. The Private Property Rights Protection
Act was approved 376-38. It restricts the federal government
from using eminent domain for private economic development and imposes
the
same prohibition on states if they receive federal economic
development funds. Concern among farm groups that governments could
take farmland
near cities and use it for suburban development prompted action from
Rep. Bob Goodlatte (R- VA), chair of the House Agriculture Committee,
who took a lead role in moving the bill through his committee and
championing
full House approval.
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Supreme Court Holds Companies Must Pay for Safety Gear Time
The Supreme Court this week unanimously said companies
must pay workers for the time it takes for them to put on protective
clothing
and safety
gear and get to their work stations. The ruling upholds a lower court
decision in a case brought by employees of a Tyson Foods meat processing
plant in Pasco, WA. The case turned not on the time necessary to don
protective clothing – the high court ruled several decades ago
that this was payable time – but on the time it took workers
to walk from place to place, including waiting time.
Return to top Harkin Says FDA BSE Feed Testing Program Flawed
Sens. Tom Harkin (D-IA) and Dick Durbin (D-IL) continued
to take shots at FDA and its handling of the BSE feed rule this week,
releasing a
letter from the Government Accountability Office (GAO) that holds FDA
is doing a poor job in its small “discrete” BSE feed testing
program. The program is designed to find feed companies mixing prohibited
ruminant rendered products into ruminant feeds. The letter was an addendum
to a February 2005 GAO report requested by the two Senators, which
itself was a follow-up to a January 2002 report on FDA’s
handling of its feed rule. Harkin released a statement calling on FDA
to remedy the problems
GAO says the feed testing takes too long, identifiable
goals are missing from the program, follow-up inspection documentation
is poor and the
agency has no way of knowing whether the testing program actually contributes
to the success of its overall BSE prevention scheme. On the criticism
testing takes too long, GAO said about 50% of the samples taken took
over 30 days to be tested and 21 samples took over 100 days, the implication
being prohibited material could have been mixed into feed and fed before
FDA even had evidence of a problem.
FDA said GAO focused on a very small part of a much
larger effort and it is unreasonable to place hard deadlines on testing
procedures.
GAO backed off a bit, saying rather than setting specific deadlines
for testing, FDA should work to set minimum time frames for collection,
testing and reporting on feed sampling.
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Japan Could Reopen Beef Market by Mid-December, But Outlook Unclear
In the first statement by a government official indicating any time
line for beef trade resumption, Japanese Ambassador to the U.S. Ryozo
Kato said in Washington this week trade could resume as early as mid-December,
despite contradictory rhetoric from Tokyo officials.
And as President Bush prepares for his Asian trade summit next week
and a stopover in Tokyo to talk beef trade, House and Senate members
continued to send public warnings to the Japanese that they will pursue
trade sanctions if beef trade isn’t resumed soon.
In a statement from Sen. Saxby Chambliss (R-GA), chair
of the Senate Agriculture Committee, that included only a reprint of
a Reuters news
story, Kato said “Most of Japan, including ourselves, expect
that resumption of beef trade will take place by the middle of December” barring
last-minute snafus. Under the U.S.-Japan October 2004 agreement, beef
from animals 20 months of age or younger would be allowed at first.
The Japanese Food Safety Commission said last week beef from the U.S.
is safe if certain safeguards are followed, including the 20-month
age limit and removal of specified risk material from feed. That statement
led to a public comment period that will end on November 29. This will
include meetings around Japan. The Japanese government said it will
send teams of experts to the U.S. and Canada in early December to inspect
meat processing plants prior to lifting its ban on North American beef
exports.
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.RES.302
Sen. Jeff Bingaman (D-NM) offered a resolution to express the sense
of the Senate regarding the impact of Medicaid reconciliation legislation
on the health and well-being of children.
S.1969
Sen. Max Baucus (D-MT) offered a bill regarding Medicaid reconciliation
legislation to be reported by a conference committee during the 109th
Congress.
S.1973
Sen. Debbie Stabenow (D-MI) introduced legislation to provide an immediate
Federal income tax rebate to help taxpayers with higher fuel costs,
to express the sense of the Senate regarding full funding of Low
Income Home Energy Assistance Program (LIHEAP) and to provide consumer
protections against fuel price gouging.
S.1974
Sen. Bill Nelson (D-FL) proposed a bill to provide States with the
resources needed to address performance-enhancing drug use in schools.
S.1978
A bill offered by Sen. Charles Schumer (D-NY) would increase criminal
penalties for the sale or trade of prescription drugs knowingly caused
to be adulterated or misbranded and to modify requirements for maintaining
records of the chain-of-custody of prescription drugs.
S.1994
Sen. Tom Harkin (D-IA) proposed legislation that would require an increasing
percentage of new automobiles be dual fueled and revise
the method for calculating corporate average fuel economy for such
vehicles.
H.R.4236
Rep. Chris Chocola (R-IN) introduced language that would treat certain
farming business machinery and equipment as five-year property for
purposes of depreciation.
H.R.4245
Rep. Jerry Lewis (R-CA) proposed legislation to provide for programs
and activities with respect to pandemic influenza.
H.R.4256
Legislation introduced by James Langevin (D-RI) would provide comprehensive,
affordable health insurance coverage for all Americans through an
American Health Benefits Program.
H.R.4282
Rep. Ron Paul (R-TX) offered a bill to amend the Federal Food, Drug & Cosmetic
Act concerning foods and dietary supplements and to amend the Federal
Trade Commission Act concerning the burden of proof in false advertising
cases.
H.R.4268
Rep. Nathan Deal (R-GA) proposed a bill to improve proficiency testing
of clinical laboratories.
Return to top
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