September 9, 2003
The Food and Drug Administration (FDA) is seeking an injunction against two companies that have been offering Canadian drugs to Americans via the Internet. The FDA says that Rx Depot, Inc. and Rx of Canada, LLC "pose a serious threat to the public health."
The FDA says it has uncovered a disturbing pattern of actions by the companies resulting in potentially hazardous errors.
An FDA investigator brought a prescription for Serzone, a powerful anti-depressant, to Rx Depot that called for 60 pills, with one pill to be taken twice each day for 30 days. Instead, the investigator received 99 pills of APO-Nefazodone, an unapproved, foreign-manufactured version of the active ingredient in Serzone.
In addition, the APO-Nefazodone package did not indicate that more than the prescribed number of pills was sent; instead, the labeling simply instructed the patient to take one pill two times a day. If the patient took the drug as instructed by the package sent from the Canadian pharmacy, he or she could have an increased risk of liver failure, which might be associated with taking the drug for an excessive period.
"FDA is compelled to act, as have other state health authorities, against this significant public health risk," said FDA Commissioner Mark B. McClellan, MD, Ph.D. "While we will continue to take every step possible under the law to help Americans get access to safe and effective, affordable medicines, we cannot and will not stand by and let aggressive companies profit through illegal actions that put the health of Americans at risk."
In addition to FDA's action, the states of Oklahoma, Arkansas, and Montana have also taken action against the companies involved.
Rx Depot originally came to the attention of the FDA through its work with the states and because of RX Depot's aggressive and misleading promotion of sales of unapproved drugs to Americans for profit, the FDA said.
During the course of investigating Rx Depot's practices, FDA investigators made undercover purchases of two products from Rx Depot's Oklahoma operation to determine the type and quality of products the firms were shipping to patients. The agency received drugs that were purported to be safe and effective, but were unapproved or illegally imported into the U.S., and potentially unsafe.
On March 21, 2003, FDA sent Rx Depot a warning letter informing the firm that, "Your actions also present a significant risk to public health, and you mislead the public about the safety of the drugs obtained through Rx Depot" and that it risked possible enforcement action if it continued to promote sales of unapproved drugs, claiming that they were "FDA-approved" and "exactly the same as if purchased in the United States."
"Unapproved drugs entering the United States through illegal channels pose a significant threat not only to good prescribing practices, but to the safety and security of the prescription drug supply in the United States," said Dr. McClellan.
"A long-distance international scheme that is deliberately out of compliance with U.S. and Canadian laws not only poses risks in itself; it also creates wide channels for criminals who only care about making a fast buck to exploit in bringing unsafe medications into the United States," he said.
"Unapproved drugs are more likely to be contaminated, counterfeit, contain different amounts of active ingredients, or contain different ingredients altogether. Now more than ever, Americans need effective protections of the safety and integrity of their prescription drugs, McClellan added."
