The US Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, has taken action against more than 1,050 websites that illegally sell,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. The IIWA is a collaborative effort between the FDA, the US Department of Homeland Security, National Intellectual Property Rights Coordination Center, INTERPOL, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, the Working Group of Enforcement Officers of the Heads of Medicines Agencies (a network of the heads of the national competent authorities in the European Economic Area), the pharmaceutical industry and national health and law enforcement agencies from 111 participating countries.
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 US 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.
Multiple centers and offices within the FDA participated in the enforcement action, which ran from June 9 to June 16, 2015. The goal of Pangea VIII , which involved 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.
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 versions of: Nolvadex (tamoxifen), Meridia (sibutramine), Valium (diazepam), Truvada (emtricitabine; tenofovir disoproxil fumarate), and Advair Diskus (fluticasone and salmeterol).
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 en route to the US.