FDA Talk Paper: Court Halts Illegal Importation of Prescription Drugs
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On December 16, 2004, the United States District Court for the Southern District of New York issued an Order of Preliminary Injunction (court order) which enjoins Canada Care Drugs, Inc. (Canada Care), Christine Ruggiero, and Claire Ruggiero (defendants) from causing the importation of drugs, receiving commissions from the importation of drugs, and advertising or promoting any importation service.
The court order gave FDA inspection authority to ensure that the defendants do not continue to violate the law. In addition, the order requires the defendants to send their customers a letter notifying them that their importation business violates the law and that the safety, purity, and efficacy of drugs obtained through the defendants cannot be assured.
The court order follows a civil complaint filed by the government against these defendants on November 29, 2004 based on an FDA investigation of Canada Care's illegal importation operations.
FDA’s investigation found products that pose a risk to the public health. FDA made two undercover purchases of the FDA-approved drugs Neurontin and Sporanox through Canada Care. Instead of Neurontin, FDA received unapproved drugs called APO-Gabapentin and Novo-Gabapentin. These unapproved drugs purchased through the defendants pose a public health threat because FDA cannot assure the safety and efficacy of unapproved drugs that are not subject to the FDA's oversight. Also, unapproved new drugs are more likely to be contaminated, counterfeit, inherently ineffective, or contain different amounts of the active ingredients from similar drugs that have been reviewed and approved by the FDA.
The shipment of Sporanox that was sent by the foreign pharmacy also posed a potentially serious health threat. The foreign pharmacy sent three packages of Sporanox at one time. Therefore, patients receiving the drugs could have taken all 84 tablets without consulting their doctor in between "pulse" treatments - an action that could have exposed them to serious and even fatal side effects.
Patients should take Sporanox in treatment "pulses" of one week, and then wait three weeks before resuming another pulse treatment. Between treatments, patients should consult their doctors to determine whether the treatment should be terminated either because it is no longer necessary or because they are experiencing liver or heart side effects.
With this preliminary injunction order in place, the case will now be scheduled for trial.