On October 4, 2012, the U.S. Food and Drug Administration (“FDA”) announced that it has taken action as part of an international campaign to protect consumers from illegal online pharmacies. Found here, the FDA’s announcement explains its involvement in the international regulatory efforts referred to as “Operation Pangea V.” The week long efforts mark the fifth annual International Internet Week of Action (“IIWA”), whereby international regulatory and law enforcement authorities engage in cooperative efforts aimed at tracking down and stopping distributors and producers of unapproved and illegal pharmaceutical products and medical devices. In addition to Operation Pangea V, the FDA recently announced the launch of various efforts to educate consumers regarding the risks of fraudulent online pharmacies. An overview of the actions against online pharmacies and related efforts may be accessed here.
Pursuant to its involvement in Operation Pangea V, the FDA notes that it sent Warning Letters to the operators of over 4,100 different online pharmacies’ websites deemed to be selling products in violation of U.S. law. Warning letters are typically the FDA’s first course of action against companies for alleged non-compliance with the FFDCA and/or FDA regulations. Under the terms of a warning letter, the FDA gives recipients fifteen (15) business days to respond in writing, detailing the specific steps taken to correct violations the FFDCA and accompanying regulations. Firms must respond to all violations, including those not explicitly cited by the Agency, or they may be subject to further agency action, including formal enforcement measures.
Because appropriate corrective measures often preclude further enforcement, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance. For more information about establishing or maintaining compliance with the laws or regulations FDA enforces, please contact us at email@example.com.