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States
to Help Residents Import Drugs From Canada
By Anna Wilde Mathews, the Wall Street Journal
December
18, 2003
Governors
and mayors across the country have come out in favor of buying cheap drugs
from
Canada
, grabbing onto a popular issue. Now, the
details of how they plan to implement such programs are beginning to
emerge.
How states and cities develop these schemes is important because the
efforts carry legal, health and political risks. All of the programs are
likely to be closely scrutinized by both sides of the national debate over
prescription-drug importation.
The Food and Drug Administration has repeatedly said it is unsafe, and
almost never legal, to import prescription drugs because they may not meet
U.S.
standards. So states that move ahead could
face legal challenges from the federal government - though such challenges
could be politically touchy since allowing Americans to import drugs is a
popular issue.
The programs also could open up the states and municipalities to private
legal action, particularly if any patients involved claim they were harmed
by the Canadian imports.
New Hampshire
, one of the boldest states, is creating a
Web site that will link its residents to Canadian pharmacies from which
they can order prescription drugs. The state says it will require that the
drugs supplied by such pharmacies come in their original packaging, an
effort aimed at curbing counterfeiting. Consumers will need to have
prescriptions signed by a licensed
New Hampshire
doctor, and a licensed Canadian doctor
also will have to be involved, says Wendell Packard, a spokesman for Gov.
Craig Benson. The new Web site, due to go live next month, will be linked
to the Republican governor's own site...
Later,
New Hampshire
plans to buy drugs from
Canada
for use by its prisoners, but it will insist that such drugs be made in
the
U.S.
as a safety measure, Mr. Packard says. The state also wants to use
mental-health drugs from
Canada
for Medicaid recipients. Mr. Packard says the state plans to move ahead
with such plans even over any federal objections.
Minnesota
is also establishing a Web site for Canadian drug purchases and has begun
elaborate preparations. The state has asked detailed questions of Canadian
pharmacies that hope to sell through the site, including how Canadian
physicians would review American prescriptions. It also requested a copy
of a pharmacy license and evidence of licenses by the pharmacists and
physicians involved.
This week,
Minnesota
pharmacy inspectors are visiting several of the Canadian companies that
said they want to participate. None will be approved without inspections,
the state says. "It's more than we would do with a pharmacy in
Minnesota
," says Kevin Goodno, the state's commissioner of human services. He
says
Minnesota
planned to move ahead with the Web site even without federal permission.
Officials in
West Virginia
are exploring plans to import Canadian drugs through local pharmacies
rather than by mail order. They want to work with Canadian provincial
authorities to verify that Canadian suppliers are legitimate, says Tom
Susman, the
West Virginia
's acting cabinet secretary for administration. The aim is to allow all
state residents to get the Canadian medicines, and integrate the import
orders into the systems of pharmacy-benefit managers, the programs through
which many workers obtain prescription drugs.
“We'll just use the normal channel, and not try to create a new
channel,” says Mr. Susman.
West Virginia
will ask for federal approval, though it's not yet clear if it would move
ahead without it.
Some states, such as
Illinois
and
Vermont
, are considering signing up state workers with a Canadian
pharmacy-benefit manager that would mail-order their drugs. A spokeswoman
for Illinois Gov. Rod Blagojevich says his state plans several safeguards,
including inspections of the facilities in the PBM's network and testing
of a sample of imported and also domestic mail-order drugs to ensure they
aren't counterfeit. The state also would create a new structure that would
link employees to pharmacists who would be responsible for tracking their
prescriptions, she says. "We're putting in place safeguards that
don't exist right now," the spokeswoman says.
Both
Vermont
and
Illinois
are seeking federal approval of their programs.Already,
Springfield
,
Mass.
, has a limited drug-importation plan that was launched in July. The
program raised the co-payments on
U.S.
drugs for city employees and retirees, while they pay nothing for those
from
Canada
. The small city's initiative so far involves only about 3,000 people
ordering Canadian drugs.
A spokesman for the U.S. Department of Health and Human Services says its
head, Secretary Tommy Thompson, doesn't have the power to grant waivers to
state and city importation programs. The secretary can under some
circumstances allow importation if he can certify that the drugs are safe,
but Mr. Thompson and previous secretaries haven't found that, the
spokesman says. Under the new Medicare bill, the department will study
whether there are ways to bring in drugs safely.
In
Canada
, regulators have made few concrete steps to stem the flood of drugs
exports, but some pharmacies are worried they could face shortages. Drug
companies are moving to curtail the supply of medicines headed through
Canada
to the
U.S.
The FDA has argued that
any drugs that fall outside the closed
U.S.
distribution system can't be guaranteed safe. State regulators, despite
the initiatives of their governors, have often sided with the FDA. Indeed,
Paul Boisseau, the executive director of
New Hampshire
's board of pharmacy, says his board hasn't worked on the state's
importation plan, and without special permission from federal authorities
the state's licensed pharmacists probably can't legally distribute
imported medicines.
Peter J. Pitts, the FDA's
associate commissioner for external relations, says litigation against
states or cities is "an option for us if we feel it is appropriate to
protect the public health." In November, a federal court ruled that a
major operator of Canadian drug storefronts, Rx Depot Inc., must stop
helping
U.S.
consumers get Canadian drugs.
In a letter to
California
officials in August, the FDA warned that "almost every time a city,
county or state program imported a drug from
Canada
, that program would violate" federal law, and "individuals or
programs that cause illegal shipments" are also illegal.
Attorneys say the states could be liable even if they are not themselves
importing the drugs. "The federal government can take the position
that the state is facilitating an action that is illegal under federal
law," says Stuart Pape, a former FDA official who is now an attorney
in private practice.
Wednesday, the FDA said it was planning to develop recommendations on how
states can save money on
U.S.
drugs through options such as substitution of generics or comparable
medicines, as well as group-purchase plans.
“We want to facilitate
states' ability to provide access to safe and effective medications within
the law,” says the agency's Mr. Pitts. The agency says it will work with
the Centers for Medicare and Medicaid Services to develop these plans.
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