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Official
Defends Sale of Flu Vaccine to U.S.
CANADA
POST — Canada's chief public health
officer defended yesterday the right of one of the
country's flu-vaccine manufacturers to sell to the
United States.
David
Butler-Jones said ID Biomedical met all its commitments
to the Canadian market before it sought to sell
its surplus south of the border. And he said that
if it came to a choice between vaccinating a healthy
Canadian or an ailing, elderly American, the call
would be an easy one:
"A
sick American versus a healthy Canadian? . . . I
would give it to the American who's at high risk."
A
vaccine supplier's failure to meet its contract
has left the United States with a shortage of roughly
45 million doses this year. High-risk Americans,
unable to find vaccine at home, have been streaming
across the border to get flu shots in Canada.
They
are not eligible for the vaccine reserved for Canada's
publicly funded flu-shot programs, which provinces
and territories pay for. That vaccine, the bulk
of Canada's supply, is reserved for Canadians deemed
to be at high risk: the old, the very young, pregnant
women and those with chronic conditions.
Instead,
Americans must access the much smaller pool of privately
purchased flu vaccine, often administered in Canadian
pharmacies or clinics to healthy adults for a fee.
The private market in Canada has generally been
small. Roughly 1.5 million doses were supplied to
the private market this year. In some areas, those
supplies are running short.
A
couple of companies that recently sought more vaccine
have criticized ID Biomedical for planning to sell
to the United States. (The sale still requires approval
from the U.S. Food and Drug Administration.) ID
Biomedical says it filled all its Canadian orders,
and more, before it offered 1.2 million doses of
uncommitted vaccine to U.S. purchasers.
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Feds
Want State's Drug Importation Suit Tossed Out
MONTPELIER
—
The Bush administration on Monday asked a federal
judge to throw out Vermont's first-in-the-nation
lawsuit seeking to overturn the government's ban
on importing prescription drugs from Canada.
In
saying the state's arguments "are simply without
legal basis," Assistant U.S. Attorney Joseph
Perella wrote that Vermont's attempt to force a
court to grant permission for drug reimportation
is inappropriate.
"The
state's claims have no basis in law and should be
dismissed," Perella said in a response filed
late Monday afternoon in U.S. District Court in
Burlington. "The actions the state asserts
that the federal defendants must take — permitting
foreign drugs to be freely imported and approving
(Vermont's) proposed plan for importing drugs from
Canada — are directly contrary to current
law."
Gov.
James Douglas and Attorney General William Sorrell
filed a complaint in federal court in August, opposing
the Food and Drug Administration's denial of a pilot
program that would have allowed 20,000 state employees,
retirees and their families to buy prescription
drugs from Canadian pharmacies.
The
governor and attorney general in the lawsuit seek
to force the FDA to promulgate regulations allowing
for such a program. They also argued that the agency
was acting in an arbitrary and capricious manner
by denying the state's request.
"Not
surprisingly, we strongly disagree with the government's
position," said Jason Gibbs, Douglas' chief
spokesman. "As the state indicated in its initial
filing, the governor believes the FDA's position
is arbitrary and unreasonable. It is unfortunate
that the federal government feels compelled to drag
its feet and waste time."
The
government, however, called the state's claims baseless
and inaccurate. In its filing Monday, the Bush administration
reiterated its position that reimporting prescription
drugs is unsafe to American consumers and patients.
The
filing also noted that the FDA is in the midst of
studying the issue, a course of action required
under the Medicare Modernization Act of 2003.
"The
federal defendants did not act in an arbitrary and
capricious manner by denying the state's petition
in light of both the statutory scheme and the federal
defendant's ongoing evaluation of issues related
to prescription drug importation," Perella
wrote. "The federal defendants are following
the law as it currently stands."
While
Vermont and the federal government trade filings
in federal court, several other states have decided
to allow their residents to participate in reimportation
programs.
In
a scheme similar to that implemented this spring
in Burlington by Mayor Peter Clavelle, Illinois,
Wisconsin and Missouri instituted the I-SaveRx plan
that gives residents of those states a way to order
prescriptions from Canada, the United Kingdom and
Ireland.
But
like Clavelle's municipal plan, actual participation
in the three-state program has been slow to catch
on.
According
to press reports from Illinois, only about 1,100
out of a pool of 5 million uninsured people have
registered with I-SaveRx. In Burlington, fewer than
100 people had signed on to buy the cheaper drugs.
Nonetheless,
say supporters of such reimportation programs, they
are a necessary step to take in lowering the cost
of prescription drugs.
Rep.
Bernard Sanders, I-Vt., has urged Douglas to join
his Midwestern colleagues. Sanders, one of the first
politicians in the country to address the issue
of high-cost prescription drugs, has contended that
the Bush administration's failure to allow drug
reimportation is tied directly to its support from
the pharmaceutical industry.
The
industry is adamantly opposed to allowing American
consumers to purchase drugs from abroad.
It
is a stance the government is still willing to take.
"The
federal defendants cannot approve, or promulgate
regulations that would permit the importation of
prescription drugs from Canada by individual consumers
via a state-sponsored importation plan or otherwise
merely because the state demands it or because some
prescription drugs are allegedly cheaper in Canada,"
the Bush administration's filing said.
"The
federal defendants share the state's concern over
the high cost of some prescription drugs,"
it added. "The state's claims, however, are
simply without legal basis."
Vermont
has about two weeks to file a response to Monday's
filing. Legal experts predicted that a judge was
unlikely to rule on the federal government's request
before the end of the year.
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How
Drugs Are Reviewed in Canada
How
are drugs reviewed in Canada?
What
is the Therapeutic Products Directorate?
What
is considered to be a drug?
How
are drugs developed?
What
is the intent of a clinical trial?
Does
the TPD review clinical trials?
What
is done with the results from clinical trials?
What
are the steps in the review process for a
drug?
Why
are some drugs not approved?
What
happens when a drug is not approved?
What
is the TPD doing to improve the efficiency
of the drug review process?
Are
some drugs reviewed more quickly?
Can
important therapies or drugs be obtained prior
to market authorization in Canada?
Once
a drug has been approved, how is it monitored? |
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