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Government News
Published Online: 21 January 2005

Planning for Safe Drug Importation

Publication: Psychiatric News
Volume 40, Number 2
https://doi.org/10.1176/pn.40.2.00400004a
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In letters sent to Senate Majority Leader Bill Frist and House Speaker Dennis Hastert, Health and Human Services Secretary Tommy Thompson and Commerce Secretary Donald Evans described the following steps that should be taken if drug importation is to be legalized:
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Integrity of the distribution system must be ensured by requiring drug pedigrees with adequate documentation, limiting ports of entry and distribution channels, and allowing commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.
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Programs must limit importation to prescription drugs most likely to yield savings—namely, high-volume products for which a U.S.-approved generic is not available—and allow importation only from countries in which the United States has a high degree of confidence in the comparability of their drug regulatory system. In the administration's view, Canada is the only country from which importation should be considered at this point.
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Programs must require that imported prescription drugs be dispensed pursuant to a valid U.S. prescription based on advice from a medical professional.
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Measures must ensure that any purchasers of imported drugs are given full and adequate information regarding the source of the drugs and that packaging and labels on imported drugs meet all FDA requirements.
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Programs must ensure effective oversight and adequate government resources to protect American consumers.
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Programs must include the ability to use streamlined inspection procedures and ensure that remedial steps can be taken in the event of adverse events from imported drugs.
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Programs must avoid anticompetitive provisions such as so-called“ forced sale” provisions and other types of price controls.

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Psychiatric News
Volume 40 • Number 2 • January 21, 2005
Pages: 4

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Published online: 21 January 2005
Published in print: January 21, 2005

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