>The Pharmaceutical Market Access and Drug Safety Act was introduced by Senators Olympia Snowe (R-Maine), Byron Dorgan (D-North Dakota), John McCain (R-Arizona), Ted Kennedy (D-Massachusetts), Tom Daschle (D-South Dakota), Trent Lott (R-Mississippi), and Debbie Stabenow (D-Michigan).
>In a press release , Senator Snowe noted, “We’re now well beyond the question of the necessity to allow for safe, regulated drug importation…A drug can be safe and effective, but what good is it if you can’t afford to take it?”
>The legislation would take what its co-sponsors described as “dramatic steps” to ensure the overall safety and integrity of the imported drugs, requiring a chain of custody or a “pedigree” be maintained and inspected. Wholesalers handling imported drugs would have to maintain high standards of record keeping, labeling, and tracking requirements, and the FDA would inspect pharmacies and wholesalers “frequently and without warning, at least every three weeks,” according to a press release.
>The bill would require that drugs be:
- approved by the Food and Drug Administration and manufactured in an FDA-inspected plant;
- patient-administered and not a controlled substance, an infused or injected drug, a biologic, or a drug inhaled during surgery;
- re-labeled in English to comply with FDA requirements (the FDA will provide approved labeling information to importers).
>It would allow importation by licensed pharmacists and wholesalers from within 90 days of enactment and from the current European Union members, , New Zealand, , and beginning one year from enactment.
>Wholesalers and pharmacies would be registered with the FDA, and the bill specifically protects pharmacies, wholesalers, and individuals from patent damages arising from the importation of drugs.
>Immediately upon enactment, an individual may import up to a 90-day supply of a prescription drug from for their personal use or for the personal use of a family member. Once the FDA has implemented regulations, individuals may be shipped purchased drugs directly only from a Canadian pharmacy registered under this Act, which must be fully inspected and approved by the FDA. Canadian pharmacies must validate a prescription, review health and medication history, and track shipments.
>The bill also allows individual Americans who travel outside the United States to bring back with them for their personal use a 90-day supply of medicine from , current countries in the European Union, , New Zealand, or , or a 14-day supply of medicine from another foreign country.
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