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For more up-to-date information, please see FDA talk paper T04-62, Court Halts Illegal Importation of Prescription Drugs.
FDA NEWS RELEASE
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FDA Takes Action Against Company for Illegal Importation of Unapproved, Potentially Unsafe Drugs
The U.S. Attorney's Office, Southern District of New York, has on behalf of the Food and Drug Administration (FDA), filed a civil complaint against Canada Care Drugs, Inc. (Canada Care), Claire Ruggiero, and Christine Ruggiero for the illegal importation of prescription drugs into the U.S.
Canada Care was previously affiliated with Rx Depot, Inc., a company that was engaged in the illegal importation of prescription drugs until November 6, 2003, when the United States District Court for the Northern District of Oklahoma entered an order of preliminary injunction against the company and its affiliates to stop their illegal activity.
"By continuing to illegally import unapproved drugs, Canada Care is putting at risk the health of patients who are expecting to improve their health," said Dr. Lester M. Crawford, Acting FDA Commissioner.
According to the complaint filed in the Southern District of New York on Monday, following the preliminary injunction order against Rx Depot and its affiliates, which was made permanent with the entering of a consent decree on August 20, 2004, Canada Care severed its relationship with Rx Depot, but continued illegal activity in violation of the Food, Drug and Cosmetic Act (FDCA).
As is alleged in the complaint, FDA's investigation of Canada Care's illegal importation operations has revealed several products that pose a risk to the public health. In February and August 2004, FDA made two undercover purchases of the FDA-approved drugs Sporanox and Neurontin through Canada Care.
Instead of Neurontin, FDA received unapproved drugs called APO-Gabapentin and Novo-Gabapentin. The unapproved drugs purchased through the defendants pose a public health threat because, as alleged in the complaint, FDA cannot assure the safety and efficacy of unapproved drugs. Because unapproved drugs are not subject to the FDA's oversight, the FDA has no knowledge how unapproved drugs are made, what patient information is included with the drug, or what the side effects of the drugs are, and as a result they 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.
In addition, as alleged in the complaint, the manner in which the Sporanox shipment was sent by the foreign pharmacy posed a potentially serious health threat to the patients who received it. Patients should take it 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. Because the foreign pharmacy sent three packages of Sporanox at one time, 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.
The complaint was filed in the United States District Court in the Southern District of New York and seeks to enjoin Canada Care from directly or indirectly importing or causing the importation of U.S.-manufactured and unapproved, foreign-manufactured prescription drugs into the U.S. in violation of the FDCA. The government will also seek preliminary injunctive relief and monetary relief in the form of restitution, disgorgement, or both.