The Food and Drug Administration (FDA) today informed CanaRx Services, Inc. (CanaRx), the business
supplying prescription drugs to the City of Springfield, Mass., that its operations are illegal under
federal law and that it continues to put American patients at risk by providing them with unapproved,
illegal, and potentially risky foreign prescription drugs.
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 prescription drugs
that may fail to meet U.S. standards, and by failing to have systems in place to assure that the prescription 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 prescription drug safety that are afforded by
the comprehensive system for assuring prescription 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 prescription medications purchased by U.S. consumers from foreign, unregulated
prescription 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 prescription 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 prescription 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 prescription 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 prescription drugs. Many of these imported prescription 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 prescription 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 prescription 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.