Clarification: FDA acts against companies importing unapproved, potentially unsafe drugs

Clarification: FDA acts against companies importing unapproved, potentially unsafe drugs

ROCKVILLE, MD., September 9, 2003 -- The FDA 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. FDA has uncovered a disturbing 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 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, Oklahoma, Arkansas, and Montana have also taken action against the companies involved.

On March 21, 2003, FDA sent Rx Depot a warning letter (www.fda.gov/foi/warning_letters/g3888d.pdf) 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."

Despite this warning, the defendants have stated that they will continue their activities until ordered by a court to stop. The FDAQ says that "these companies' aggressive and continuing violations of a fundamental public health law create significant, potential health risks associated with buying unapproved and illegally imported medicines from unregulated sources".

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. 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.

A particularly disturbing example was a 30-day prescription order placed with Rx Depot for Serzone, a powerful anti-depressant drug. An FDA investigator bought 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 Dr. McClellan. "FDA does not have the resources 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. Now more than ever, Americans need effective protections of the safety and integrity of their prescription drugs."

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 to assure drug effectiveness, safety and purity. Recent attempts by others to introduce counterfeit drugs, controlled substances, drugs that pose special health risks, expired or otherwise subpotent drugs, and seriously mislabeled drugs into the American marketplace underscore the serious public health threats patients face without proper prescription drug safeguards. These safeguards are provided by a comprehensive drug safety system that FDA has developed based on Federal law and in conjunction with many other Federal and state authorities and health professional associations. This system provides critical safety assurances, at every step from drug manufacturing and distribution to appropriate prescribing and patient education, to help make sure that patients get the most benefits and avoid the important risks of prescription drugs.

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:

  • Greater availability of generic drugs: Approved generic drugs are just as safe and effective as their brand-name counterparts, and generally cost around 70% less. In August, FDA implemented a new regulation to speed up the availability of generic versions of important prescription drugs, expected to save consumers over $3 billion per year. Earlier this year, FDA announced major reforms in the generic drug approval process to make generic alternatives available sooner.
  • Greater help for consumers and their physicians on how they can use prescription drugs effectively, and without costly complications: Recent FDA initiatives include new regulations for bar coding medications, to prevent many thousands of costly medical errors each year, and new electronic systems for collecting information on adverse events and for informing patients and health care providers about the risks and benefits of prescription drugs.
  • Steps to reduce the high and growing costs of developing and manufacturing prescription drugs, without compromising safety: The FDA is implementing major reforms in pharmaceutical "good manufacturing practices" to improve the efficiency of drug manufacturing while maintaining and improving FDA's high standards for product quality.
  • Assistance in enacting legislation to provide an effective drug benefit in Medicare: In addition to providing seniors with a drug benefit and the opportunity to band together to negotiate much lower prices, legislation now being considered by Congress would help seniors and their doctors benefit from electronic prescribing based on FDA standards, and enhanced safety and information systems.

The complaint will be filed in the United States 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 U.S.

Source: FDA

Posted: September 2003


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