FDA Begins Crackdown on Canadian Rx Imports

Provided by ConsumerAffairs.Com

March 21, 2003
True to its word, the Food and Drug Administration (FDA) has begun clamping down on the flow of prescription drugs from Canada to the United States. The agency today issued a warning letter to Rx Depot, Inc., of Lowell, Ark., alleging that its operations were "illegal and a risk to public health."

The FDA accused Rx Depot of running a "storefront" operation and said it is "particularly concerned because Rx Depot is making misleading assurances to consumers about the safety of their drugs." The Arkansas State Board of Pharmacy also issued a letter to Rx Depot instructing the firm to cease violating state law immediately.

The FDA announced it would begin enforcing rules against importing drugs from other countries after GlaxoSmithKline began withholding its drugs from Canadian pharmacies suspected of selling them to Americans seeking lower drug prices.

The FDA denies its action is political motivated and says it 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," the agency said in a statement.

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.

The FDA says it is taking steps to help American consumers get safe access to low-cost prescription drugs. The agency said it 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 says it is significantly expanding its generic drugs program to approve safe and effective generic drugs more quickly. These steps will supposedly result in billions of dollars in prescription drug savings each year.