FDA takes action against import of unapproved drugs

The Food and Drug Administration has asked the Department of Justice to file a complaint for injunction against Rx Depot Inc., and Rx of Canada LLC (Rx Canada), to stop them from importing drugs that pose a serious threat to the public health. According to a Sept. 9 release, the FDA has uncovered a pattern of actions by these companies resulting in potentially hazardous errors.

"FDA is compelled to act, as have other state health authorities, against this significant public health risk," said FDA Commissioner Dr. Mark B. McClellan. "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.

On March 21, FDA sent Rx Depot a warning letter that said, "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."

Despite this warning, the defendants have stated that they will continue their activities until ordered by a court to stop.

Rx Depot originally came to the attention of the FDA through its work with the states and because of its aggressive and misleading promotion of sales of unapproved drugs to Americans for profit.

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 United States, and were potentially unsafe.

A particularly disturbing example was a 30-day prescription order placed with Rx Depot for Serzone, a powerful anti-depressant drug. An FDA investigator brought a prescription for Serzone 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.

"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 McClellan.

"Under current law, FDA does not have the resources or the legal authorities necessary to assure the safety of unapproved drugs imported into the United States. 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. Unapproved drugs are more likely to be contaminated, counterfeit, contain different amounts of active ingredients, or contain different ingredients altogether."

In light of such risks, FDA is alerting the American public to avoid purchasing drugs that come from any source operating outside the safeguards of systems established by the United States and governments of other nations.

The FDA has also taken many steps to help consumers meet their medication needs at a more affordable price, without compromising drug safety and effectiveness. These include the following steps:

Greater availability of generic drugs. In August, FDA implemented a new regulation to speed up the availability of generic versions of important prescription drugs, expected to save consumers more than $3 billion per year.

Greater help for consumers and their physicians on how they can use prescription drugs effectively, and without costly complications.

Steps to reduce the high and growing costs of developing and manufacturing prescription drugs, without compromising safety.

Assistance in enacting legislation to provide an effective drug benefit in Medicare.

The complaint will be filed in the U.S. District Court in the Northern District of Oklahoma and will seek preliminary and permanent injunctive relief. It will seek to enjoin Rx Depot and Rx Canada and individual officers from directly or indirectly importing or causing the importation of U.S.-manufactured and unapproved foreign-manufactured prescription drugs into the United States.