Pharmacy Group Seeks Injunction to Block Maine Law Allowing Drug Imports
A federal court should issue a preliminary injunction barring the state of Maine from implementing its pharmaceutical import law, said a suit filed in the U.S. District Court for Maine by a group of pharmacists and drug retailers. The law, enacted earlier this year, expressly authorizes foreign pharmaceutical vendors to export prescriptions drugs into the U.S., circumventing federal regulations on prescription drugs "and thus posing serious health risks to consumers," the suit said.
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The Maine law also "poses an obstacle to the federal government’s ability to achieve the goals of its prescription drug regulatory regime, and is an invalid attempt at legislating in a field totally occupied by the federal government," said the complaint, filed on behalf of the Maine Pharmacy Association, Maine Society of Health-System Pharmacists, Retail Association of Maine, two individual pharmacists and the Pharmaceutical Research and Manufacturers of America. Jones Day attorneys Michael Carvin and John Gore are representing the plaintiffs.
The suit claims the Maine law bypasses the federal Food, Drug, and Cosmetic Act (“the FDCA”), which prohibits the import of any “new drug” that has not received approval from the Food and Drug Administration. It quoted the FDA as saying “virtually all prescription drugs imported for personal use into the United States from Canada” or other countries “violate the FDCA because they are either unapproved new drugs[,] labeled incorrectly[,] or dispensed without a valid prescription.” The FDA has also said imported drugs can be fake or have manufacturing defects that could affect health, it said.
The suit also cites the responsibilities of licensed pharmacists in Maine, and says the import of drugs bypasses those responsibilities, and says the imports can bypass prescription requirements. Domestic pharmaceutical manufacturers invest substantial money, time, and resources in producing high-quality prescription drugs that comport with the strict requirements of federal law, the complaint says.
The suit says the Maine law violates the Supremacy Clause of the U.S. Constitution, which says federal law “shall be the supreme law of the Land.” It says federal law specifically prohibits import of any prescription drugs that have not been labeled in accordance with federal law, including requirements pertaining to the content of warning labels and use of the English language. The FDA has advised over a dozen states that state laws allowing the import of foreign pharmaceuticals would violate federal law, it said.
Email ITTNews@warren-news.com for a copy of the complaint.