- WASHINGTON (Reuters) - U.S.
regulators on Thursday warned three Texas-based companies that they were
illegally helping employees and retirees of Montgomery, Alabama, import
medicines from Canada.
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- The action is the latest in a Food and Drug Administration
(FDA) effort to try to stop Americans from buying cheaper medicines from
other countries. The FDA and drug manufacturers say the practice is risky,
but many critics are skeptical of the safety concerns.
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- The FDA said it sent warning letters to Expedite-RX,
a pharmacy benefits manager; SPC Global Technologies Ltd., an insurance
claims processor, and Employer Health Options Inc., an insurance company.
All are based in Temple, Texas.
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- The letters informed the firms the FDA "considers
their drug import program to be illegal and a risk to public health,"
an agency statement said.
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- The FDA asked the companies to reply within 15 working
days explaining what steps they will take to comply with U.S. law, which
forbids anyone other than drug manufacturers from importing medicines into
the country.
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- Tom Curb, a spokesman for the three companies, said the
FDA's letter included "inaccurate allegations," and he was preparing
a response. He said the companies were not running a drug import program
and that the FDA had misunderstood their relationship.
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- "I don't think what we are doing is illegal,"
Curb said.
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- Expedite-RX provides prescription data to SPC's processing
database, allowing for checks for possible interactions between U.S. and
Canadian-dispensed prescriptions, he said. The company also refers patients
to a licensed Canadian or local pharmacy, whichever is cheaper.
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- Between 200 and 300 Montgomery workers and retirees have
participated in the city's Canadian drug plan with Expedite-RX, said Jeff
Downes, executive assistant to the city's mayor.
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- Amid growing interest in drug imports, the FDA and drug
makers have warned that medicines shipped to the United States from abroad
could be counterfeit, contaminated or too weak. Critics charge that drug
makers only want to protect their profits.
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- Twenty-five U.S. states and 15 localities are looking
into importing medicines from Canada, according to officials with the Pharmaceutical
Research and Manufacturers of America, a drug industry lobbying group known
as PhRMA.
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- Drug makers are advocating alternatives for saving on
prescription costs, including company offers of free or discounted medicines
for the poor and new Medicare discount cards.
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- Importing "is a false solution. There are many better
options for patients," said Rick Smith, senior vice president for
communications and policy for PhRMA.
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