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By Robert Pear
Congress is taking steps to allow imports
of prescription drugs from Canada, in the hope of giving American
consumers access to lower-priced medicines.
The Food and Drug Administration and drug
companies oppose the legislation, but many lawmakers said
they know of no serious safety hazards with Canadian imports.
"It
would be very hard for anyone to make a credible case that
there is a risk in importing drugs from Canada,"
said Senator Byron L. Dorgan, Democrat of North Dakota, who
is leading efforts to relax restrictions on such imports.
A law adopted last year allowed pharmacists,
drug wholesalers and distributors to import low-priced prescription
drugs from 26 countries including Canada, Japan, Israel and
members of the European Union.
But the law gave broad discretion to the
secretary of health and human services. The Bush administration
and the Clinton administration both refused to issue rules
to carry out the law. They said they could not certify that
the import plan would be safe and would save money for consumers.
In an interview, Mr. Dorgan said, "We
are narrowing the bill this year to focus on imports from
Canada as a first step."
The broader proposal was included in a
spending bill approved last year by votes of 86 to 8 in the
Senate and 340 to 175 in the House. A measure dealing just
with Canada could pass even more easily, Mr. Dorgan and other
lawmakers said.
In July, by a vote of 324 to 101, the
House approved a bill that would make it easier for people
to import low-cost prescription drugs for their own use. Mr.
Dorgan plans to offer his proposal on the Senate floor this
month.
Proposals to allow drug imports appeared
unexpectedly on the House floor last year without much study
or analysis by the committees that usually handle health care
legislation.
The idea has attracted serious attention
in recent weeks as the federal budget surplus has shrunk,
making it more difficult for Congress to add drug benefits
to Medicare, the federal health program for the elderly and
the disabled.
Senators James M. Jeffords, independent
of Vermont, and Debbie Stabenow, Democrat of Michigan, are
working closely with Mr. Dorgan to push legislation through
the Senate.
Drug costs were one of the top issues
in Ms. Stabenow's campaign last year. She organized bus trips
to Canada for Michigan voters who wanted to buy prescription
drugs at the lower prices available there. Prescription drugs
are subject to price controls in Canada, as in many industrial
countries.
The bill Mr. Dorgan and his colleagues
are drafting, like the one enacted last year, says that
imported drugs must comply with all the safety and labeling
requirements that apply to drugs made and distributed
in the United States. Each batch of imported drugs would have
to be tested for purity, to make sure it was not adulterated
or misbranded.
Stephen L. Giroux of Middleport, N.Y.,
a pharmacist who owns three drugstores about 40 miles from
the Canadian border, said, "I would be totally confident
and comfortable buying products from Canadian suppliers."
At a Senate hearing this week, William
K. Hubbard, senior associate commissioner of the Food and
Drug Administration, said he "would have a relatively
high degree of confidence" in drugs purchased in Canada.
But he said that large-scale imports from Canada would pose
immense challenges to the F.D.A.
Drug manufacturers and distributors said
they now had virtually complete
control over the custody of prescription drugs,
from the factory floor to the retail pharmacy. But after drugs
leave the United States, they said, they could not be sure
of the conditions under which the drugs are stored and handled.
Canada has a sophisticated system for
regulating drugs. But Mr. Hubbard said he could not give assurances
about the safety of products imported from Canada because
he did not know how the drug distribution system worked there.
"Once a drug goes into the Canadian
market, it's outside F.D.A. jurisdiction," Mr. Hubbard
said, adding that "all sorts of malevolent things"
could happen to drugs there.
Senator Dorgan said he considers the drug-import
bill a tool to "put
pressure on drug companies to lower their prices."
Congressional aides who have visited Canada
and studied the pharmaceutical market there said it was unrealistic
to think that the United States could solve its problems by
giving United States consumers access to the Canadian market.
Canada has a population of 31 million,
compared with the United States' population of 285 million.
Alan Sager, a professor at the Boston
University School of Public Health, said drug makers could
try to thwart Mr. Dorgan's bill by limiting the supply of
drugs available in Canada for export to the United States.
Drug companies would, in effect, be competing
with themselves if they sold large amounts of drugs in Canada,
only to see the products shipped to the United States for
sale here at discount prices.
Mary R. Grealy, president of the Health
Care Leadership Council, a coalition of chief executives from
large health care companies, said Canada could become "a
trans-shipment point" for counterfeit drugs being sent
to the United States from third-world countries. "You
don't know where drugs in Canada came from," she said.
"They could have been made or stored in third-world countries
with no regulation at all."
Federal law says that a prescription drug
made in the United States and exported may not be imported
to the United States except by the manufacturer. The law,
adopted in 1988, sought to end a "gray market" for
drugs that were counterfeit, adulterated or too old to be
used safely.
The 1988 law, drafted by Representative
John D. Dingell, Democrat of Michigan, was widely seen as
a consumer protection measure. Congressional investigators
had documented many cases in which counterfeit drugs, including
birth control pills, had been imported.
New York Times
September 9, 2001
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