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The Food and Drug Administration (FDA) today issued a warning letter to Rx Depot, Inc., of Lowell, Ark., notifying that firm that the agency considered the firm's operations to be illegal and a risk to public health. FDA accused Rx Depot of running a "storefront" operation that illegally causes the shipment of prescription drugs from a Canadian pharmacy into the U.S. FDA is particularly concerned because Rx Depot is making misleading assurances to consumers about the safety of their drugs. FDA is acting today in conjunction with action by the Arkansas State Board of Pharmacy, which also issued a letter to Rx Depot instructing the firm to cease violating state law immediately.
FDA is very concerned that foreign medications purchased by U.S. consumers from unregulated drug outlets pose a growing potential danger. This is particularly true because Rx Depot and similar companies often state incorrectly to consumers that the FDA condones their activities and even that their prescriptions are "FDA approved," which could lead consumers to conclude mistakenly that the prescription drugs sold by the companies have the same assurance of safety as drugs actually regulated by the FDA.
State pharmacy boards are responsible for determining whether pharmacies operating within the state are doing so in compliance with state law. In all states, it is a violation to sell prescription drugs in the state without proper licensing by the state.
FDA believes that operations such as this one expose the public to the significant potential risks associated with unregulated imported prescription medications. Because the medications are not subject to FDA's safety oversight, they could be outdated, contaminated, counterfeit or contain too much or too little of the active ingredient.
In addition, foreign dispensers of drugs to American citizens may provide patients with incorrect medications, incorrect strengths, medicines that should not be used in people with certain conditions or with other medications, or medications without proper directions for use. For example, some prescription medications advertised by Rx Depot have potentially serious side effects, contradictions, and drug/food interactions. Since these medications are not subject to FDA labeling or state board of pharmacy medication information requirements, consumers are at higher risk.
As this action indicates, the FDA intends to work closely with its partners in the individual states in support of their efforts to curtail illegal and potentially dangerous operations, especially when they involve misleading claims about drug safety. The National Association of Boards of Pharmacy (an umbrella group representing state pharmacy boards) which is urging FDA to assist in acting against these schemes stated, "allowing unlicensed practitioners to dispense non-FDA approved medicines without regard for patient health and safety sets a dangerous precedent that puts Americans at risk." FDA has been working closely with states on illegal Internet pharmacy issues over the past four years, to protect the public health. While many internet pharmacies provide safe and possibly more convenient access to prescription services, foreign internet pharmacies selling 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 is taking many actions to help American consumers get safe access to low-cost prescription drugs. For example, FDA is about to issue a final rule that will address issues in the implementation of the "Hatch-Waxman" law that will support more timely access to lower-cost generic drugs, and the FDA is significantly expanding its generic drugs program to approve safe and effective generic drugs more quickly. These steps will result in billions of dollars in prescription drug savings each year. FDA is also improving its prescription drug regulatory process, with the goal of reducing the cost of developing new drugs. However, despite continued efforts to identify ways to assure the safety of reimported drugs, the FDA for many years has stated that it cannot assure the safety of prescription drugs that are obtained outside its comprehensive regulatory system.
FDA's action follows the agency's recent notifications that businesses engaging
in practices like those used by Rx Depot are at risk for legal action (see http://www.fda.gov/ora/import/kullman.htm).
Rx Depot has fifteen working days to respond to FDA's warning letter. FDA will
take appropriate action, including collaborative actions with individual states
and foreign governments, to stop similar illegal activities by this or other
similar firms.
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Rx Depot, Inc. Warning Letter (pdf)