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FOR IMMEDIATE RELEASE |
Media Inquiries: 301-827-6242 |
FDA has issued a warning letter to Discount Prescriptions from Canada, Inc., a Fairview, W.Va. business operation that helps its customers import illegal prescription drugs from a Canadian pharmacy. The letter informs the company that the agency has determined their operation to be in violation of the Federal Food, Drug and Cosmetic Act which safeguards the safety and efficacy of the Nation's drug supply.
The warning letter notes that statements on website through which the drugs are sold are misleading because they lead U.S. consumers to believe that drugs imported from Canada are as safe as domestically dispensed prescription drugs. In fact prescription drugs purchased from foreign countries generally are not FDA-approved, do not meet FDA standards, and do not have the same assurance of safety as drugs regulated by FDA.
"This action is essential to protecting the public health, and it demonstrates FDA's commitment to supporting states who take action against those who import potentially risky foreign drugs. Unapproved drugs from foreign countries are outside of FDA's safety oversight, they could be outdated, contaminated, counterfeit or contain too much or too little of the active ingredient," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "In addition, foreign dispensers of drugs to Americans may provide patients with incorrect medications, or improper directions for use – things that can turn even a useful drug into a potentially harmful one. We are working hard to give Americans greater access to safe and affordable drugs, but illegal drugs that do not assure safety are no bargain"
The letter also notes that unapproved drugs coming into the U.S. through Canada, or purportedly from Canada, may not actually be Canadian drugs. Recent examples of counterfeit products entering the U.S. marketplace also raise substantial safety questions about drugs from foreign countries. Drugs delivered to the American public from foreign countries may be very different from products approved by FDA and may not be safe and effective. FDA believes that operations such as Discount Prescriptions from Canada, Inc., therefore expose the public to significant potential health risks.
FDA continues to find numerous safety problems relating to prescription drugs being mailed into the United States from Canada without effective regulatory oversight. For example, recently officials from the state of Minnesota evaluated eight Canadian pharmacies that send drugs to the United States. They found thirty-two distinct violations of safe pharmacy practice, including the following:
At least one pharmacy provided drugs that apparently were not of Canadian origin.
In contrast to its role in assuring the safety of prescription drugs distributed in the United States, FDA has no way to assure the safety of drugs supplied by these Canadian pharmacies.
FDA's warning letter also refutes misleading claims by the company that such unapproved foreign drugs can be legally imported into the country. The letter makes it clear that drugs lacking the safeguards provided by the Federal Food, Drug and Cosmetic Act cannot be substituted for approved drugs of known safety and efficacy
Discount Prescriptions from Canada, Inc., is required under the terms of the warning letter to notify FDA in writing within fifteen working days of the specific steps it has taken to assure its full compliance with the law. If adequate steps are not taken, FDA may pursue further legal action needed to protect the public health.
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