FDA Takes Action Against Sale of Unapproved Rx Products

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-09-2016 14:36


The US Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, has taken action against 4,402 websites that illegally sell unapproved prescription drugs to US consumers. This effort was part of Operation Pangea IX, the Ninth 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 goal of Operation Pangea IX was to identify the makers and distributors of illegal prescription drug products and to remove these products from the supply chain.

The FDA’s Office of Criminal Investigations, Office of Regulatory Affairs, and Center for Drug Evaluation and Research participated in the enforcement action, which ran from May 31 to June 7, 2016. The FDA conducted inspections at International Mail Facilities (IMFs) in coordination with US Customs and Border Protection and sent formal complaints to domain registrars requesting the suspension of the 4,402 websites. Included are 110 websites that sell the chemical 2,4-dinitrophenol (DNP) as a weight-loss product. DNP is most often used as a dye, wood preserver, and herbicide and has never been approved by the FDA for use as a drug.

During the IIWA, the FDA, in addition to requesting the suspension of 4,402 websites, issued warning letters to the operators of 53 websites illegally offering unapproved and misbranded prescription drug products for sale to US consumers. FDA inspectors, in collaboration with other federal agencies, screened and seized illegal drug products received through IMFs in San Francisco, Chicago, and New York. These screenings resulted in the detention of 797 parcels which, if found in violation of the Federal Food, Drug, and Cosmetic Act, will be refused entry into the country and destroyed.

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, Heads of Medicines Agencies Working Group of Enforcement Officers, the pharmaceutical industry and national health and law enforcement agencies from 115 participating countries.

Source: Food and Drug Administration


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