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On March 9, 2006, the United States District Court for the Southern District of New York entered a Consent Degree that permanently 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 drug importation service.
Additional FDA inspections, as directed by the court order, will be used to ensure that the defendants do not continue to violate the law. In addition, the court ordered the defendants to surrender to the U.S. Treasury $4,000 in profits from their illegal activities.
"This court order is another example of the FDA's efforts to stop illegal drug imports – a practice which can present a health hazard to patients," said Margaret O'K. Glavin, Associate Commissioner for Regulatory Affairs. "Our agency will continue to help protect Americans from potentially harmful consequences of this practice, while also working to help assure that Americans have access to quality, safe, and effective products."
The permanent injunction is the result of a legal process that started on November 9, 2004, when the federal government filed a civil complaint against these defendants based on an FDA investigation of Canada Care's illegal importation operations. This consent decree of permanent injunction follows one filed August 20, 2004 in the case of Rx Depot and Rx of Canada, where the defendants were also ordered to cease all operations involving the illegal importation of prescription drugs.
FDA's investigation, conducted in February and August, 2004, involved undercover purchases of prescription medications through Canada Care. Medications purchased outside the consumer safety protections built into the U.S. drug distribution system are a public health concern because patients cannot be sure of the quality or the safety and effectiveness of such drugs. In addition, as in the case of products purchased undercover by FDA from Canada Care, these kinds of products are often shipped with inadequate instructions for use or in inappropriate quantities that facilitate use of the product without the input of a physician that is needed to assure that the product is used in a manner to prevent serious, and even fatal, consequences.
In addition, previous FDA investigations found that drugs purchased under these conditions are more likely to be contaminated, counterfeit, inherently ineffective, or contain different amounts of the active ingredients from similar drugs that are FDA approved and are safeguarded by the consumer protections built into the U.S. drug distribution system.
For more information go to: www.fda.gov/bbs/topics/news/2004/NEW01142.html and www.fda.gov/bbs/topics/ANSWERS/2004/ANS01337.html.
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