Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
Food and Drug Administration (FDA) - November 6, 2003
These conclusions came in FDA's formal reply to a letter from CanaRx in which the firm outlined certain operational changes it made following receipt of a warning letter from FDA last September. (The warning letter is available online at http://www.fda.gov/bbs/topics/NEWS/2003/NEW00946.html.
Today's letter reiterates FDA's serious safety concerns about the business practices and continuing illegal actions that may put the firm's customers at risk.
Specifically, FDA's letter to the firm finds that:
CanaRx's practices create many potential safety risks, for example, by causing the importation of drugs that may fail to meet U.S. standards, and by failing to have systems in place to assure that the drugs it provides are prescribed and distributed in accordance with applicable federal laws, and CanaRx's operational changes do not provide the same assurances of drug safety that are afforded by the comprehensive system for assuring drug safety in the U.S.
"The drug safety laws that Congress has charged FDA to enforce require that drugs be proven to be safe and effective to be legal," said Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D. "While FDA will continue to do all it can to make safe and affordable drugs available, we are also committed to enforcing the law against those, whether governmental or private, who endanger Americans by profiting from 'buyer beware' schemes to import illegal, unapproved and potentially risky medicines."
FDA has long been concerned that medications purchased by U.S. consumers from foreign, unregulated drug outlets pose a growing potential danger. CanaRx and similar companies often state incorrectly to consumers that their products are "FDA approved" or use similar language, which could lead consumers to conclude mistakenly that the prescription drugs sold by the companies have the same assurance of safety and effectiveness as drugs regulated by the FDA. They do not.
The medications obtained and shipped by operations such as CanaRx are not subject to FDA's safety oversight. This gap prevents assurance that CanaRx's medications are safe and effective, are prescribed and distributed properly, and otherwise meet U.S. prescription drug standards. In this case, these risks are heightened by the fact that many of the products CanaRx sells to U.S. consumers are indicated for serious medical conditions.
In addition, foreign dispensers of drugs to American consumers may provide patients with incorrect medications, drugs with incorrect strengths, medicines that should not be used by people with certain conditions or with other medications, or medications without proper directions for use.
For example, of the 1,153 imported drug products examined during a recent "blitz" by FDA and the Bureau of Customs and Border Protection, the overwhelming majority, 1,019 (88%), were illegal because they contained unapproved drugs. Many of these imported drugs could pose clear safety risks to consumers. These drugs arrived from many countries, with 15.8% (161) entering the U.S. from Canada.
Finally, there are no reliable methods to detect adverse events caused by drugs supplied by firms like CanaRx, or to take action against the company when adverse events occur. In fact, companies like CanaRx routinely state that they have no liability or responsibility for adverse consequences of the drugs they provide.
Although many legitimate domestic Internet pharmacies provide safe and possibly more convenient access to prescription services, foreign Internet pharmacies selling unapproved foreign drugs to the U.S. operate outside the law. FDA provides guidance to consumers on buying prescription drugs safely over the Internet at http://www.fda.gov/oc/buyonline/default.htm.
FDA Letter to CanaRx Services, Inc., Nov. 6, 2003
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P03-93 November 6, 2003
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SOURCE: Food and Drug Administration (FDA).
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