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November 22, 2003 |
GOP-Led House Approves Medicare
Bill (AP) |
|
November 18, 2003: |
Canada Deaf to U.S. Plea on
Internet Drug Sales (Reuters) |
|
November 15, 2003: |
Ban drug exports, say regulators.
Selling to U.S. makes policing druggists impossible. (National
Post) |
|
November 13, 2003: |
Pawlenty Pleased With Standards
at Canadian Online Pharmacies (AP) |
|
November 12, 2003: |
Mail Order Companies to Outline
Safety Measures for N.D., Minn. Delegation (AP) |
|
November 11, 2003: |
State Continues Canadian Drug
Benefit (Rutland Herald) |
|
October 29, 2003: |
Canada challenges U.S. to block
cheap drug flow (Reuters) |
|
October 26, 2003:
|
U.S. Report Back Importing Cheaper
Canadian Drugs (Reuters) |
|
October 20, 2003: |
Iowa Plans to Procure Drugs From
Canada
(Washington Post) |
|
October 14, 2003: |
Blagojevich unveils on-line
petition drive pressing FDA to reverse its policy on importing
prescription drugs from Canada (Office of the Govenor,
Illinois) |
| June 20,
2003: |
Senate Votes to Allow Drug
Reimportation From Canada (AP) |
| |
|
GOP-Led House Approves
Medicare Bill
By DAVID ESPO, AP
Special Correspondent
WASHINGTON -
The Republican-controlled House approved a bitterly contested
Medicare prescription drug bill early Saturday in an epic
struggle settled near dawn. The vote was 220-215.
Passage of the measure capped an extraordinary roll call
that began at 3 a.m. and consumed nearly three hours before
the GOP leadership could overcome a rebellion by conservatives
in their own ranks and the overwhelming opposition of
Democrats.
"In the end, democracy works," said Rep. David Hobson,
R-Ohio, as weary Republicans marked their overtime victory.
"We won it fair and square and they stole it by hook and
crook," countered House Democratic Leader Nancy Pelosi.
The vote sent the measure to the Senate, where supporters
expressed growing confidence they would prevail. President
Bush is eager to sign the bill, which would give 40 million
seniors and disabled Americans a prescription drug benefit and
a new option for private health care coverage.
"After this legislation goes into effect, low-income
seniors will never be confronted with the choice of putting
food on the table or paying for life-saving prescription
drugs," Speaker Dennis Hastert said well after midnight, just
before the lights dimmed in the chamber to signal the
beginning of the longest roll call in the history of the
House.
But Pelosi said seniors know that her party gave birth to
Medicare during the Great Society, adding, "we want to protect
it and strengthen it. America's seniors have also known where
Republicans stand, for four decades they have waged war on
Medicare."
The bill represented a political compromise of sorts — the
new prescription drug benefit, coupled with federal subsidies
designed to give private insurance companies incentives to
establish new managed care plans around the country.
Republicans said these new plans, either preferred provider
organizations or HMOs, would modernize Medicare, providing
better coverage at lower cost. Democrats expressed skepticism,
saying they marked the first step on the road toward
privatization.
Dozens of lawmakers, participants and spectators both,
waited out the drama of the middle-of-the-night roll call, as
Hastert, his lieutenants and Department of Health and Human
Service Secretary Tommy Thompson shuttled from one GOP holdout
to another seeking enough votes to prevail. GOP aides said
Bush lobbied by phone from the White House.
The vote was stuck at 216 to 218 for over an hour, and the
bill appeared on the verge of defeat, before a flurry of
last-minute switches. "I did not want to vote for this bill,"
said Rep. C.L. (Butch) Otter, R-Idaho. He did, one of a
handful of late GOP converts, He said afterward he became
convinced that if the measure were defeated, another one would
come back to the House floor even less to his liking.
The bill drew the support of 204 Republicans and 16
Democrats, many of whom waited until the bill appeared on the
verge of passage in the final moments of the roll call before
swinging behind it. Voting no were 189 Democrats, 25
Republicans and 1 independent.
Nearly 20 hours earlier, Republicans projected confidence,
even bravado. "I look forward to the presidential signing
ceremony," said California Rep. Bill Thomas, a key architect
of a measure making the most sweeping changes in Medicare
since the program's creation in 1965.
But that was before the near-solid wall of Democratic
opposition, the stubborn refusal of conservatives to bend, the
hours of debate, the behind-the-scenes lobbying, the
presidential phone calls from Air Force One and the
still-undisclosed deals made to secure passage.
"You'd think we were talking about different bills from the
rhetoric we've heard this evening," said Rep. Deborah Pryce,
R-Ohio, as the debate unfolded Friday night.
There was no disputing that.
"This is a defining issue," said Rep. Jim McGovern,
D-Mass., as he made a case for rejecting the measure. "This
bill is a huge giveaway to the prescription drug companies.
And worst of all, this bill shoves Medicare down that path
toward privatization."
"This bill is really all about a fair deal," countered
Thomas, the chairman of the House Ways and Means Committee.
"Modernize Medicare with prescription drugs, but put Medicare
back on a sound financial basis as well."
As written, the legislation would virtually remake
Medicare.
For the first time, seniors earning more than $80,000 a
year would be required to pay a higher premium for their Part
B non-hospital coverage under Medicare.
For the first time, the legislation would also require
seniors with annual incomes over $80,000 to pay higher
premiums under Medicare Part B, which covers services outside
the hospital. Additionally, it would establish new
tax-preferred health accounts, open to individuals with
high-deductible insurance policies.
The tax provision and the requirement for higher premiums
were part of an effort to appeal to conservatives who favor
transforming Medicare and restraining its cost, yet find
creation of the new prescription drug benefit distasteful.
Many Democrats argued that some of the conservative-backed
elements of the bill were too dear a price to pay for the drug
benefit — particularly a provision creating a limited
experiment in direct competition between private plans and
traditional Medicare beginning in 2010.
Conservatives said just the opposite.
Rep. Tom Feeney, R-Fla., fielded an afternoon phone call
from Bush, who was flying home from England aboard Air Force
One. "I basically said it was a matter of principle, that I
came to Washington not to ratify and to expand Great Society
programs," said the first-term lawmaker. "He wasn't happy to
hear that."
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Canada Deaf to U.S. Plea on
Internet Drug Sales
By Randall Palmer
OTTAWA (Reuters) - The top U.S. drug regulator called on
Canada on Tuesday to do more to counter the sales of cheap
prescription drugs into the United States, but the plea fell
largely on deaf ears, with Ottawa saying the issue was a
essentially a domestic U.S. problem.
The remarks were made in Ottawa against the backdrop of an
increasing flow of lower-cost prescription drugs from Canada
to individual Americans -- notably hard-pressed seniors -- and
calls by city and state governments in the United States to
follow suit in order to lower the cost of expensive medical
plans.
"Our concern is that this system in Canada, that assures
drug safety in Canada, is not set up to assure the safety of
large volumes of drugs shipped over the Internet from
unregulated or poorly regulated sources to Americans," said
Mark McClellan, head of the U.S. Food and Drug Administration.
His Canadian counterpart, Assistant Deputy Minister of
Health Diane Gorman, has taken the position that it was
primarily a problem for Washington to deal with, not Ottawa.
"My responsibility is to make sure that Canadian law ... is
respected. The U.S. FDA is sharing some information with us.
We are investigating a number of issues that they've brought
to our attention," she told a news conference.
But she added: "At this point in time we don't have
evidence of Canadian law being broken."
Reflecting on her view, McClellan said: "Maybe what Diane
is saying ... is that there are not any real safety issues at
the moment for Canadians.
"I think there are other Canadians who would dispute that
-- for example all the (provincial) regulators who do see some
real safety risks for Canadians too."
Some Canadian pharmacists have voiced concern that supplies
from foreign drug manufacturers may be held back in an attempt
to choke off the Internet pharmacies. They have also said it
was unethical for Canadian doctors to sign off on U.S.
prescriptions without seeing the patients.
"I think it is clear ... that there is a way for Canadian
government officials to take more actions to assure the safety
of these products," McClellan said.
McClellan and Gorman were speaking after signing a
memorandum of understanding on exchanging information on a
wide range of topics, most prominent of which was the issue of
Internet pharmacies.
The agreement appeared to be aimed, at least partly, at
bridging the U.S.-Canadian gap on whether there is a problem
of safety and supply of the prescription drug sales.
"We have no evidence at this point in time in the case of
Internet pharmacies of unsafe products going to the United
States," Gorman said.
In a speech before the two officials spoke to reporters,
McClellan also called on Canada and other developed countries
-- which all set drug prices lower than in the United States
-- to share more of the burden of developing drugs.
"If all we do is focus our efforts on getting lower prices,
then all that we will end up paying for is the cost of making
and distributing the pills themselves," he said, which would
leave development costs for Americans and others to pay.
"This isn't a sustainable situation. We need fairer and
better ways to encourage the development of better medicines,"
he said.
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Ban drug exports, say
regulators. Selling to U.S. makes policing druggists
impossible.
By Tom Blackwell, National Post
The bodies
that regulate pharmacies across Canada are calling on the
federal government to ban the cross-border sale of
prescription drugs to the United States, arguing they cannot
police druggists whose customers are in a different country.
Some of those
customers have already lodged complaints against Canadian
pharmacies, creating difficult challenges for the regulators,
said the National Association of Pharmacy Regulatory
Authorities.
The body is
also concerned about possible shortages of drugs and
pharmacists for the Canadian market as a result of the
cross-border business.
Coming from a
group of apolitical professional organizations, the
association's call for a ban is the strongest assault yet in
Canada against the burgeoning, but controversial, export
industry.
"There are
increasing questions and reports on drug shortages," said
Barbara Wells, executive director of the umbrella group for
provincial and territorial agencies.
"It just stands
to reason that if we are going to be supplying the U.S.
market, this is just the tip of the iceberg."
However, the
groups believe the trade might eventually be viable if a
system can be created to permit international regulation, Ms.
Wells added.
The request
that Health Canada shut down the business at least temporarily
was endorsed yesterday by the U.S. Food and Drug
Administration, which is strongly opposed to the importation
of prescription drugs.
A ban is
absolutely necessary, Tom McGinnis, the FDA's director of
pharmacy affairs, said in an interview. "It's illegal."
Mark McLellan,
the agency's commissioner, is scheduled to visit Health Canada
officials in Ottawa on Tuesday to discuss the issue.
The pharmacy
regulators' statement got a much different reception from the
mail-order pharmacy business, which has grown within barely a
year to sell as much as $1-billion of medication to the United
States annually.
The declaration
was a "ridiculous and rash, draconian step," said David Mackay
of the Canadian International Pharmacy Association.
He noted the
regulators in at least one province, Manitoba, have
specifically agreed to oversee the international business,
even drawing up special standards for it.
"To suggest all
of a sudden that the regulatory authorities cannot stand by
these agreements is an indictment of themselves," Mr. Mackay
said. "It's saying their own system is incompetent."
In Manitoba,
where the bulk of the mail-order pharmacies are located, fees
from such businesses to the regulator, the Manitoba
Pharmaceutical Association, total more than $700,000 a year,
he said, allowing them to hire extra staff. Despite repeated
inspections, no transgressions have been uncovered, Mr. Mackay
said.
But there
appears no immediate threat that Health Canada will take up
the national regulatory association's suggestion.
"It is
premature to consider banning export of prescription drugs
because there is no evidence of drug shortages related to
Internet pharmacy," said Krista Apse of Health Canada.
"Our bottom
line is to ensure that Canadians continue to have access to
affordable, safe drugs when they need them."
Still, the
department will continue to monitor the situation closely, she
said.
The regulatory
association's members licence pharmacists, investigate
complaints and mete out discipline when necessary. The
Manitoban regulator has already received some complaints from
the United States, although no more, proportionately, than it
would normally get from Canadian pharmacy customers, she said.
But officials
worry about their ability to subpoena witnesses from the
United States, if necessary, or obtain confidential medical
information from south of the border, which might be needed in
an investigation of alleged wrongdoing, she said.
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Pawlenty Pleased With
Standards at Canadian Online Pharmacies
Associated Press
WINNIPEG,
Manitoba (AP) - More U.S. politicians will start looking to
Canada's Internet pharmacies as a way to save money on costly
prescription drugs south of the border, Minnesota Gov. Tim
Pawlenty predicted Wednesday.
"I think you're
going to see more governors, more mayors, more people come on
board,'' Pawlenty said after touring CanadaDrugs.com, a
Winnipeg business where operators fill up to 1,700
prescriptions a day, most of them destined for the United
States.
Pawlenty gave
the growing cyber-drug industry a big thumbs-up after his tour
to review safety standards at online pharmacies in Manitoba,
home to one-third of Canada's 150 Internet operations.
"I came away
reassured and excited,'' he said.
Last month, he
announced plans to help people in his state buy cheaper drugs
from Canada via the Internet. Those plans include negotiating
drug prices and setting up a Web site linking Minnesotans to
Canadian pharmacies that meet state standards.
"We were told
that the Canadian system meets or exceeds the FDA's (U.S. Food
and Drug Administration's) requirements and expectations for
safety,'' he said.
"We also
learned that there are a number of Canadian federal and
provincial and industry protocols and accreditations ... and
as you look at that it appears to be meeting or exceeding the
safety stands in the United States.''
The FDA opposes
the importation of drugs from Canada and other countries. It
says some drugs don't meet U.S. specifications on
refrigeration and labeling.
Also opposed
are big pharmaceutical companies, who say the lost revenue
from American sales will stifle their research into new drug
treatments. Four drug companies, including Pfizer and
GlaxoSmithKline, have begun limiting supply to Canada to curb
exporting, and have threatened to go further.
"In my own
view, the actions and threats of the pharmaceutical industry
in this regard are reprehensible,'' Pawlenty said.
"They're just
threatening flat out in the United States that they might
retaliate against Canadian pharmacies by withholding supply.
If it were to become the case, I would hope and I would
strongly encourage legal action against the pharmaceutical
industry to prohibit that,'' he said.
Manitoba
Premier Gary Doer said he doesn't believe any kind of
artificial barriers should be put up.
"We don't have
a Berlin Wall across the Minnesota-Manitoba border,'' he said
after meeting with Pawlenty.
"If we do
believe in fair trade, we should continue the practice of
trade, and pharmaceuticals should be part of that trade,'' he
said.
Manitoba raises
an estimated $150 million a year in taxes from Internet sales.
Several
Democratic and Republican governors and a majority of members
in the U.S. House of Representatives support importing drugs
as a way to keep costs down.
Illinois Gov.
Rod Blagojevich sent a delegation to Manitoba last month to
examine the Internet pharmacy trade, and commissioned a report
that said the state could save about $91 million a year by
buying drugs from Canada for its employees and retirees.
Some studies
have estimated prescription drugs in Canada are as much as 60
percent less expensive than in the United States for several
reasons, including federal government regulation.
Opposition to a
cross-border pharmacy industry has been brewing on this side
of the border as well, however. Some Canadian pharmacists
believe it will lead to higher prices and a shortage of drugs
in the country.
Federal Health
Minister Anne McLellan has said she wants to know whether the
booming export industry is leaving pharmacists in Canada short
of drugs.
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Mail Order Companies to
Outline Safety Measures for N.D., Minn. Delegation
By DAVE
KOLPACK, Associated Press Writer
WINNIPEG,
Manitoba -- Large Canadian and American flags hang from the
main call center at CanadaDrugs.com, where operators fill
between 1,300 and 1,700 prescriptions a day, almost all for
customers in the United States.
Business
is booming at most mail order and Internet pharmacies in
Canada, despite warnings by pharmaceutical companies and the
U.S. Food and Drug Administration about the safety of imported
drugs.
"We're
not hidden in a back room, we're not smacking mosquitos and
we're not counting polar bears," said CanadaDrugs.com
spokesman Bob Fraser, giving a tour of the 24,000-square feet
facility. "We have nothing to hide. We welcome all
inspections."
Fraser
and his company were preparing this week for a visit today
from North Dakota and Minnesota government officials,
including North Dakota Lt. Gov. Jack Dalrymple and Minnesota
Gov. Tim Pawlenty.
Pawlenty
has said he wants to set up a Web site that would list
approved Canadian distributors of prescription drugs.
Eventually, he hopes to expand his plan with incentives for
state employees who use the site.
One
purpose of the trip, which includes meetings with Canadian
officials, drug wholesalers and pharmacists, is to talk about
safety.
Safety
standards for mail order and Internet pharmacies in Canada
already exceed those in the United States, said David MacKay,
executive director of the Canadian International Pharmacy
Association.
"This
whole premise that our system is not as safe, or it could
introduce counterfeits, is a bogus premise," said MacKay, who
will host the Americans. "The pharmacies are bona fide
licensed pharmacies, fully inspected by the provinces they do
business in."
"A lot of
the governors know they can seize upon this as a political
agenda and are genuinely interested in helping their
citizens," MacKay said. "They know that a lot of their
citizens are already ordering from Canada, so why not set up a
system that helps them as a resource to make an educated
decision to purchase safely?"
The North
Dakota and Minnesota officials plan to tour CanadaDrugs.com,
which MacKay said is the benchmark in the industry. It's one
of 18 member pharmacies in CIPA, he said.
Any U.S.
prescription is checked by five professionals before it
reaches the patient, Fraser said. That includes three
pharmacists at the plant, one Canadian doctor and the U.S.
doctor who writes the prescription.
"On a
daily basis we catch drug allergies, potential interactions,
duplication on therapy and inappropriate therapy," Fraser
said.
All drugs
are inspected, approved and registered by Health Practices and
Food Branch, Canada's version of the United States' Food and
Drug Administration, Fraser said. All packages are sealed with
the original manufacturer's label, he said.
CanadaDrugs.com does 87 percent of its business over the phone
and 13 percent on the Internet, which is typical for most
companies, MacKay said.
"We
require prescriptions, we require a patient medical history,
and we require a patient agreement which put the onus on us to
continue the care between the patients and us."
There
have been no cases of counterfeit drugs in Canada, MacKay
said. Compared to the United States, it's easier to monitor
drug wholesalers in Canada because they are federally
regulated and there are fewer of them, he said.
"The less
stops along the way, the less opportunities to introduce
counterfeit medications," MacKay said.
Calls to
the Pharmaceutical Research and Manufacturers of America were
not immediately returned.
The drug
supply is safer in Canada than in the United States, said
Peter Wycoff, spokesman for the Minnesota Senior Federation,
"This
whole idea that the FDA can't guarantee the safety of drugs
from other countries may be true, but it can't prove the
safety of drugs in this country, either," Wycoff said. "The
FDA is only now getting around to suggesting that
factory-sealed containers might be a good idea in this
country."
Wycoff's
group has an agreement with CanadaRx of Toronto under which
any member can get drugs mailed from Canada at about half the
U.S. retail price. Many of the members are not familiar with
the Internet and want help with paperwork, he said.
"A person
can go to any one of 30 to 40 legitimate pharmacy systems and
do the same thing," Wycoff said. "The big issue is to be
doubly sure that any pharmacy you're dealing with is licensed
by the province."
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State Continues Canadian Drug
Benefit
By Bruce
Edwards
RUTLAND HERALD -
A South Burlington company that helps Vermonters purchase
lower-priced Canadian prescription drugs has withstood a
challenge from the Vermont Board of Pharmacy.
The Vermont Board of Pharmacy filed a complaint earlier this
year with the secretary of state’s Office of Professional
Regulation alleging that Discount Prescription Services
(formerly American Drug Club) should be shut down because it
was not a licensed pharmacy, according to Thomas Anderson,
president of Discount Prescription Services.
An ensuing investigation found no basis for the complaint of
unprofessional conduct, which was dismissed in September.
“We’re not a pharmacy, and we don’t stock any drugs or sell
any drugs,” Anderson said.
Rather than being in the business of selling prescription
drugs, Anderson said his company helps Vermonters obtain their
medications from a licensed Canadian pharmacy, helping clients
fill out the required paperwork, which is then mailed or faxed
to Canada. Clients then receive their medications in the mail,
usually within two weeks
The Vermont Board of Pharmacy complaint stemmed from concerns
about the safety of imported prescription drugs. Board member
John Dorvee said that “the complaint was dismissed because we
don’t have jurisdiction over someone who has a storefront
operation.” Dorvee indicated, however, that one option to halt
the importation of drugs from Canada into Vermont would be to
take action directly against Canadian pharmacies because those
pharmacies are not licensed to sell drugs in Vermont.
Anderson, who also sells life and group health insurance,
started Discount Prescription Services earlier this year to
help Vermonters purchase Canadian drugs, which cost 30 to 80
percent less than the same drugs sold in the U.S.
Today, Anderson said, Discount Prescription Drugs has several
hundred customers, mostly senior citizens on fixed incomes,
who have a hard time paying for their U.S.-bought medications.
He said approximately 80 percent of the business is repeat
orders.
Like the Vermont Board of Pharmacy, the federal Food and Drug
Administration has balked at endorsing the reimportation of
Canadian drugs. But Anderson argues that safety is not an
issue.
“There certainly haven’t been any problems at all,” he said.
“As long as we deal with Canada, they operate exactly as we
do.”
While heartened by the ruling by the secretary of state’s
office, Anderson said the real answer lies in lowering
prescription drug prices in this country.
There is growing sentiment in Congress to legalize the
reimportation of prescription drugs from Canada. Late last
month, a contingent of state and local officials from Vermont
attended a meeting in Boston on the issue.
Anderson said he has received support from Rep. Bernard
Sanders, I-Vt., and Sen. Patrick Leahy, D-Vt. He said he has
met with Burlington officials as that city contemplates
assisting its employees to purchase cheaper drugs north of the
border. He said he also receives referrals from the Chittenden
County Area Agency on Aging.
Anderson said he is still considering opening a branch office
in Rutland. The company also has a Web site at
www.burlingtondrugclub.com, where someone can fill out the
necessary forms to obtain prescriptions from Canada.
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Canada challenges U.S. to block
cheap drug flow
By Randall Palmer
OTTAWA, Oct 29
(Reuters) - The Canadian government has challenged the United
States to block the flow of cheap prescription drugs from
Canada if it thinks it is a problem, a senior health official
said on Thursday.
The challenge
was made in discussions with the U.S. Food and Drug
Administration as controversy swirls over the idea of U.S.
seniors, cities and states filling their prescription needs in
Canada.
"We have
reminded the United States that they have responsibilities and
they have authorities within their own country to stop the
importation of products within their own country, and have
reminded them of their responsibilities in that regard," the
official told a media conference call.
It is
technically illegal under U.S. law to import drugs from
foreign pharmacies. And while the FDA says imported drugs are
risky and it would like the practice to stop, it has not yet
moved to stop the flow.
Meanwhile,
Canada has reinforced to the FDA that its drugs are safe and
has asked it to provide evidence of any products coming in
through Canada that do not meet Canadian regulations.
"To date, we
have not received that evidence," the official said.
Canada's
Assistant Deputy Minister of Health, Diane Gorman, was
traveling to Washington on Thursday for a previously scheduled
meeting with FDA Commissioner Mark McClellan.
The whole issue
of Internet pharmacies, which are used to sell to the United
States, was not on the agenda but was certain to come up
during their talk, the Canadian official who briefed reporters
said.
The Canadian
government broke its public silence on the issue this week by
calling on pharmacy and medical associations to condemn the
Internet pharmacy practice and spoke of the risk that it could
cause shortages in Canada -- though it said it had no evidence
of this yet.
New York City
Mayor Michael Bloomberg said on Thursday that New York State
could save $643 million a year by buying drugs from Canada for
Medicaid patients.
He was the
latest in a string of mayors and state governors who have
started looking north for cheaper drugs.
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U.S. Report Backs Importing
Cheaper Canadian Drugs
CHICAGO (Reuters)
- Importing cheaper prescription drugs from Canada could save
Illinois up to $90 million a year without compromising safety,
says a state report released on Sunday.
Investigators
found that drugs from Canada are safe and effective, that
Canadian regulators provide protections that are about the
same as those in the United States, and that drugs sold in
Canadian pharmacies are made in facilities approved by Health
Canada, the federal health agency.
"Both
countries' methods of ensuring safety and efficacy of
prescription drugs are comparable," says a summary of the
report released by Illinois Gov. Rod Blagojevich and U.S. Rep.
Rahm Emanuel, an Illinois Democrat.
Blagojevich
ordered the study in September to determine whether medicines
from Canadian sources could provide a safe alternative and
help the state and its employees and retirees save money.
Other states
including Iowa, Minnesota, Wisconsin are looking at buying
prescription drugs from Canada for state workers or for
state-run Medicaid health programs.
Last week New
York Mayor Michael Bloomberg called the concept "a great idea.
... It is on our to-do list."
A growing
number of U.S. residents are already ordering prescription
drugs over the Internet or buying them outside the United
States, where regulatory differences makes them substantially
cheaper.
U.S. states,
struggling with record budget shortfalls and increasing
numbers of uninsured, are challenging warnings from the U.S.
Food and Drug Administration that the safety of imported drugs
cannot be guaranteed.
Congress is
debating adding a prescription drug benefit to the Medicare
health insurance program. The pharmaceutical industry is
fighting one version that would make it substantially easier
to import drugs from outside the United States.
Importing
prescription drugs is technically illegal except by
manufacturers. There is a gray area, however, under which
drugs can be imported for personal use.
The Illinois
report said there is an additional guarantee of safety because
Canadian pharmacies fill prescriptions in amounts supplied by
the manufacturer in sealed containers only. They do not open
manufacturer supplied containers, count and repackage to fill
the prescription as done in the United States, it said.
The report said
if all eligible Illinois prescriptions were filled through
Canada, state employees and retirees using three prescriptions
a month would save up to $1,008 per year, and overall savings
for the state and employees combined would be as high as $90.7
million annually.
Copyright ©
Reuters 2003
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Iowa Plans to Procure Drugs From Canada; State Joins
Growing Group Seeking Cheaper Medicines Outside U.S
By Ceci Connolly
WASHINGTON POST - I owa
Gov. Tom Vilsack said he intends to seek lower-priced
medicines from Canada for state employees, a move that puts
added pressure on Congress and the Food and Drug
Administration to find a way to control the soaring cost of
prescription drugs in this country.
Vilsack, a Democrat, became
the second governor in 10 days to join a growing contingent of
advocacy groups, for-profit businesses and one city in looking
across the border for cheaper drugs.
"People do not understand how they can purchase something
in Canada for far less than it costs here in the United
States," Vilsack said in an interview.
Vilsack and Illinois Gov. Rod Blagojevich (D) have asked
aides to draft plans for state health insurance programs to
buy medicines from Canadian suppliers.
If the savings are significant, Vilsack said, "we should
take every step possible to . . . take advantage of these
Canadian opportunities."
This year, Iowa is spending $ 54 million on drugs for
70,000 employees, retirees and their families, up from $ 44.5
million in 2001, officials said. Vilsack said he is
dispatching his top health care adviser to Vancouver to meet
with Canadian officials on ways to open the border for legal
drug importation.
As many as 2 million Americans now purchase prescription
drugs illegally outside the United States, according to
government and private estimates, but the FDA has done little
to stop individuals and nonprofit groups from buying drugs in
Canada and Europe, where the savings range from 30 percent to
75 percent.
William Hubbard, senior associate commissioner at the FDA,
repeated the agency's standard warning that it cannot
guarantee the safety of medicines coming from other countries.
FDA inspectors and undercover investigators have found
numerous instances in which medications alleged to have come
from legitimate Canadian pharmacies were counterfeit,
mislabeled or expired, he said.
Such warnings have had little effect, however.
"They can't stop this momentum," said Springfield, Mass.,
Mayor Michael J. Albano. "They can't stop this movement." The
city has registered 1,100 city workers and retirees for a
newly launched prescription drug plan based in Canada, and
Albano has rebuffed FDA urgings that he desist.
Elsewhere, however, the FDA is pursuing a court injunction
to halt Canadian drug sales by Oklahoma-based Rx Depot and has
sent stern warning letters to another importer, CanaRx, and
the state of California, which also expressed interest in
Canadian imports.
With limited resources, the FDA has put profit-making
importers at the top of its priority list for enforcement,
Hubbard said.
"You can't be selective in your enforcement," said Rep.
Rahm Emanuel (D-Ill.), who is co-sponsoring legislation to
open Canadian and European markets. "It's either a public
health risk or it's not."
Other experts contend drug importation regulations are
vague and ripe for a court challenge. "The law authorizes the
FDA to prevent unsafe drugs from coming into America," said
Kip Sullivan, a universal health care advocate in Minnesota
who has organized drug-buying trips to Canada. "That's
different from saying the FDA has the authority to stop all
foreign drugs."
Others argue the FDA is not fulfilling its obligations.
"What proof is there that there is a significant risk?"
Vilsack asked. "And if there is a risk, let's do something
about it."
In recent weeks, both sides have ratcheted up their
efforts. In Congress, a bipartisan coalition is threatening to
oppose broad Medicare prescription drug legislation if it does
not include provisions allowing consumers to shop for better
prices in Canada.
Recently, 142 House Democrats sent a letter to the members
of a Medicare conference committee suggesting they were
"unlikely to support a Medicare drug benefit that does not
include" language making it legal to purchase FDA-approved
drugs from Canada. In July, 243 House members, including 87
Republicans, voted for the legislation.
Senate Finance Committee Chairman Charles E. Grassley
(R-Iowa) has said he supports that approach, but his House
counterpart, Ways and Means Committee Chairman Bill Thomas (R-Calif.),
does not.
Several lawmakers said the drug importation issue, often
called "reimportation" because many Canadian medications are
made in the United States, has become politically potent
because it marries economic concerns with fair trade issues
and general principles of equity.
Said Rep. Richard E. Neal (D-Mass.), "You are hearing it at
home, no matter where you travel."
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Blagojevich unveils on-line
petition drive pressing FDA to reverse its policy on importing
prescription drugs from Canada
Governor asks consumers to help
put pressure on federal government to open access to lower
priced medicines
Launches
new website:
www.affordabledrugs.il.gov
CHICAGO
(OFFICE OF THE GOVERNOR) – Gov. Rod R. Blagojevich today
announced he is enlisting the help of American drug consumers
in his effort to convince the U.S. Food and Drug
Administration to change its policy prohibiting states and
local governments from buying FDA-approved medications for a
lower price from
Canada.
The Governor is asking consumers to fill-out an on-line
petition in support of drug importation at
www.affordabledrugs.il.gov.
“The FDA can
ignore our letters. They can ignore our calls. But they
can’t ignore the people forever. And so today, I’m launching
an electronic petition drive so that the people can be heard
on this issue,” said Blagojevich.
“If you
think that you should be able to reduce your prescription drug
costs – let the FDA know. Let the FDA know they can’t keep
hiding behind the excuse of safety. Let the FDA know you want
your prescription drug costs reduced. Log on to our website
at
www.affordabledrugs.il.gov – sign our electronic petition
– and let your voice be heard.”
The on-line
petition is part of a new website launched by the state today
with information about the discrepancy between American and
Canadian drug prices, the impact of high prices on consumers –
especially the elderly, activity in Congress on the issue and
recent editorials from
around the
nation in support of drug importation efforts. The site
contains a price comparison chart where viewers can assess
their potential savings if they were able to buy their
prescription medications at Canadian rates.
In addition
to the on-line effort, the Governor said petitions will be
available in hard-copy at senior citizen facilities throughout
the state, or can be requested over the phone by calling
toll-free (866) 296-6322.
In
September, the Governor asked the state’s two Special
Advocates on prescription drugs to study and report to him on
the cost-savings and feasibility of reimbursing state
employees and retirees – and potentially enrollees in the
state’s new senior citizen discount buying club – for drugs
they purchase in Canada, where prices are significantly
lower.
Illinois
currently spends $1.8 billion a year on prescription drugs for
all its health care programs combined, $340 million of that is
just for state employees and retirees.
Last week
the Special Advocates led a delegation of the administration’s
top policy, medical and legal experts on a fact-finding trip
to Canada. The group met with executives from CanaRx, the
company that administers the drug import program for the city
of
Springfield,
MA, as well as pharmacists and executives from retail and
online pharmacies and representatives from the Canadian
government. The delegation will use the information it
gathered in the report it is preparing for Blagojevich on the
benefits and challenges of importing drugs.
While he
awaits the results of the Special Advocates’ study, Gov.
Blagojevich has been lobbying the FDA and Congress to change
current rules that prohibit state and local governments,
pharmacies and consumers from buying prescription drugs from
Canada.
Blagojevich pointed out the contradictory messages the FDA
sends out on the safety of Canadian drugs, claiming imported
medications do not meet up to U.S. standards and therefore
will not be allowed to enter the American market, while at the
same time looking away as more than a million individuals in
the U.S. cross the border or send away to purchase their
prescription drugs for significantly less from Canada.
“The FDA, to
date, has refused to permit state and local governments to
import prescription drugs from Canada. They say we can’t do
this because it may not be safe. While they use that reason
time after time, the FDA has yet to explain why they permit
private health plans to reimburse their members for purchasing
prescription drugs from Canada,” the Governor commented.
“Either it’s
safe or it’s not safe. If it’s safe, let the people benefit.
If it’s safe, stop doing the dirty work for the drug
manufacturers, and start giving people the chance to save some
money. If it’s not completely safe just yet, instead of just
throwing up your hands and refusing to deal with the issue,
let’s work on finding ways to make it safe,” Blagojevich
urged.
Blagojevich
will deliver the petitions gathered from the website and
partners around the state to the FDA to demonstrate the wide
support for allowing states to find new solutions to the
worsening crisis from high drug prices.
“If we make
our voice heard – if we tell the FDA that we’re not going to
just let them ignore the needs of tens of millions of
Americans – if we demand that they stop protecting the
interests of the big drug companies, then maybe they’ll start
working for the interests they’re supposed to serve: the
people,” the Governor added.
The Special
Advocates’ report will be submitted before the end of October.
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Senate Votes to Allow Drug Reimportation
From Canada
Associated Press
WASHINGTON
(AP) — The Senate voted Friday to allow U.S. pharmacists to
buy prescription drugs in Canada, where the same medicines
sell for less, and resell them here, another attempt to drive
down the rising cost of drugs.
The 62-28 vote
attached the measure to the pending Medicare prescription drug
bill moving through Congress, where approval in the House and
Senate was expected by the end of next week.
Lawmakers,
especially those living in states bordering Canada, have been
pressing for the change for years, spurred in particular by
senior citizens in their states who board buses to cross the
border and buy cheaper drugs.
But the provision
includes a measure that could prevent it from ever becoming
law: It requires the secretary of health and human services to
certify that the reimportation can be done safely. A similar
law is already on the books, but former HHS Secretary Donna
Shalala would not certify that it could be done without risk
to patients. Her successor, Tommy Thompson, said the same.
That didn't stop
the Senate from acting. Sen. Byron Dorgan, D-N.D.,
successfully argued that Canada's safety controls were just as
reliable as those in the United States and U.S. consumers have
nothing to fear from drugs bought from Canadian pharmacists.
He added that this
bill is different because it allows reimportation only from
Canada, where the drug safety system is nearly identical to
the U.S. system. Prices are lower, however, because the
government controls them by law.
"If you believe
it's unfair that we pay the highest prices in the world for
prescription drugs, then vote for my amendment," Dorgan said.
Opponents argued
that it poses a particular danger in today's age of bioterror
threats.
"It opens a new
door, a new opportunity, and it is a new threat to the
security of the people of this country," said Sen. Thad
Cochran, R-Miss.
The vote followed
approval a day earlier of another strategy to drive down
prices, overwhelmingly endorsing a plan to bring generic
medicines to the market more quickly, 94-1.
"This is a very
good day for consumers," Sen. Charles Schumer, D-N.Y., said
after the generic drug provision was added Thursday.
The generic drug
provision essentially codifies regulations issued by the Food
and Drug Administration last week to make it more difficult
for brand-name companies to block generic competition.
The provision also
is designed to penalize generic drug companies if they enter
deals in which brand-name competitors pay them to delay
bringing the lower-cost alternative to market.
Off the Senate
floor, a block of conservatives was lobbying to boost support
for private companies, and it appeared that lawmakers had
brokered a compromise to satisfy them. Conservatives see
private insurance as the future of Medicare in delivering both
drugs and routine health care.
Fearful that
seniors would stay away from new managed care options being
created by the bill, they want to pay private companies more,
hoping the benefits would be good enough to attract a
significant number of the elderly.
In the House, the
second of two committees approved its version of a Medicare
bill Thursday, defeating a series of Democratic amendments
aimed at sweetening the benefits and reshaping the program.
Approval by the House Energy and Commerce Committee, on a near
party-line 29-20 vote, sent the bill to the House floor for
debate next week.
The $400 billion,
10-year Medicare plan would, for the first time, give all
seniors federal subsidies to buy prescription drugs, relying
principally on private companies to deliver the benefit. It
also would create a new Medicare managed care option —
preferred provider organizations — which supporters hope would
give seniors more choice while saving the government money.
At issue, though,
is how much money the government will have to pay PPOs to
attract seniors. The Congressional Budget Office estimated
that, as written, the bill would attract just 2% of seniors
into PPOs, though other estimates put it higher.
At a stormy
closed-door meeting Thursday, Republicans led by Sen. Jon Kyl
of Arizona demanded more money for PPOs. They want payments to
be based on competitive bidding by the insurance companies,
not on the normal price of caring for a Medicare enrollee.
Senate Majority
Leader Bill Frist, R-Tenn., said he was well aware of the
tension and was trying to walk a careful line. "I'm going to
do my best not to let it be an extreme bill to the left or to
the right," he said.
Frist had $12
billion not yet allocated to help solve this problem and one
other: how to keep employers from dropping coverage for their
retirees once the Medicare benefit kicks in.
The controversy
set off a series of daylong meetings involving key lawmakers
and Thompson, officials said. At day's end, Frist said he
hoped for a compromise that would give Kyl and conservatives
their way, but only after a delay of four or five years. And
he said Friday that compromise was still on track.
Copyright 2003 The Associated Press
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