Enforcement Action Detaining Dangerous Counterfeit Medicines and Devices Sold Online

The FDA, in partnership with international regulatory and law enforcement agencies, took action recently against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical devices to consumers. These actions include the issuance of regulatory warnings to the operators of offending websites and seizure of illegal medicines and medical devices worldwide.


The action occurred as part of the Eighth Annual International Internet Week of Action (IIWA), a global cooperative effort, led by INTERPOL, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products on the Internet. This enforcement action ran from June 9 to June 16, 2015.


As part of this year’s international effort – Operation Pangea VIII – the FDA sent Warning Letters to the operators of nearly 400 websites offering unapproved or misbranded prescription medicines to U.S. patients and to nine firms distributing unapproved or uncleared medical devices online. FDA inspectors, in collaboration with other federal agencies, screened and seized illegal drug products and medical devices received through International Mail Facilities (IMFs) in Chicago, Miami, and New York during the IIWA. These screenings resulted in 814 parcels being detained and referred to appropriate FDA offices for follow up. Parcels found in violation of the Federal Food, Drug and Cosmetic Act will be refused entry into the country.


The goal of Pangea VIII – which involves law enforcement, customs, and regulatory authorities from 115 countries – was to identify the makers and distributors of illegal prescription drug products and medical devices and to remove these products from the supply chain.


“Our efforts to protect the health of American patients by preventing the online sale of potentially dangerous illegal medical products will not cease,” said George Karavetsos, director of the FDA’s Office of Criminal Investigations. “Operation Pangea VIII provides yet another avenue for the FDA to engage with our international law enforcement partners on these critical issues. We are not only pleased to be a part of this strong international enforcement effort, but resolved to do everything we can to ensure that the global problem of illegal Internet drug and device sales is deterred as a result.”


Some of the unapproved prescription drugs targeted during Operation Pangea VIII that purport to be FDA-approved generic versions of brand name drugs and are sold illegally by the websites included: “Generic Nolvadex,” “Generic Meridia,” “Generic Valium,” “Generic Truvada” and “Generic Advair Diskus.”


Some of the devices sold illegally online and targeted during Operation Pangea VIII included “The Ondamed System” and “Colon Care Products of PA Open System Colon Hydrotherapy Device (Grace)” as well as illegal dermal fillers such as “Interfall Hydrogel polyacrylamide dermal filler,” “Dermafil hyaluronic acid dermal filler” and “Teosyal hyaluronic acid dermal filler.”


Preliminary findings from drug products screened at IMFs show that certain drug products from abroad, such as antidepressants, hormone replacement therapies, sleep aids and other drugs to treat erectile dysfunction, high cholesterol and seizures were enroute to U.S. consumers.


In addition to health risks, illegal online pharmacies and illegal online medical device retailers pose other risks to consumers, including credit card fraud, identity theft, and computer viruses. The IIWA is a collaborative effort between the FDA, the U.S. Department of Homeland Security, National Intellectual Property Rights Coordination Center, INTERPOL, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, Heads of Medicines Agencies Working Group of Enforcement Officers, the pharmaceutical industry, and national health and law enforcement agencies from 111 participating countries.


See the FDA Announcement


See also Medical Law Perspectives, January 2014 Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians


See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication