Federal Court Strikes Down Maine Law on Prescription Drug Imports
The Maine U.S. District Court on Feb. 23 invalidated a Maine state law allowing importation of prescription drugs from certain countries for personal use. The Maine law, which took effect in October 2013, allows mail-order pharmacies in Canada, the United Kingdom, Australia and New Zealand to export prescription drugs to Maine residents (see 13101011). The District Court said the law conflicts with the federal responsibility of regulating foreign commerce.
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According to District Judge Nancy Torresen, the federal Food, Drugs, and Cosmetics Act creates a framework to regulate the importation of drugs into the U.S., including from which countries they may be imported. Amendments in 2003 to the FD&C Act explicitly allowed for importation of prescription drugs from pharmacies licensed in Canada, although they required the Secretary of Health and Human Services to first certify that it would be safe and cost-effective, which has not since occurred.
Nonetheless, with a federal law on the books explicitly regulating importation of drugs from entities licensed in foreign countries, Maine can’t make its own state law on the subject, said the District Court. The amendments’ “singling out of certain countries from which pharmaceuticals may be imported compromises the tightly regulated structure set up by the FDCA and the federal government’s ability to ‘speak with one voice’ when it regulates foreign commerce,” said Judge Torresen.
Email ITTNews@warren-news.com for a copy of the ruling.