FDA targets unlawful internet sales of illegal prescription medicines during international operation Pangea IX
FDA has requested the suspension of 4,402 websites and has issued warning letters to the operators of 53 websites illegally offering unapproved and misbranded prescription drug products for sale to US consumers.
The FDA, in partnership with international regulatory and law enforcement agencies, took action this week against 4,402 websites that illegally sell potentially dangerous, 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 co-operative effort, led by INTERPOL, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products on the internet.
“Preventing illegal internet sales of dangerous unapproved drugs is critical to protecting consumers’ health,” said George Karavetsos, director of the FDA’s Office of Criminal Investigations. “Operation Pangea IX demonstrates the FDA’s continuing commitment to stand united with our international partners to protect consumers in the United States and throughout the world from criminals who put profit above the health and safety of consumers.”
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 31 May to 7 June 2016. The FDA conducted extensive inspections at International Mail Facilities (IMFs) in co-ordination 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.
A recent FDA task force investigation into the distribution of DNP resulted in a 9 May 2016 guilty plea from Adam Alden of Bakersfield, California, for introducing an unapproved drug into interstate commerce. A Rhode Island customer who purchased DNP via the internet from Alden, among other sources, died in October 2013 as a result of DNP ingestion.
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.
Preliminary findings from drug products screened at the IMFs show that US consumers had purchased certain unapproved drug products from abroad to treat depression, narcolepsy, high cholesterol, glaucoma, and asthma, among other diseases. Consumers should be cautious when buying prescription drugs online. For tips on how to identify an illegal pharmacy website and advice on how to find a safe online pharmacy go to BeSafeRx: Know Your Online Pharmacy.
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.
Related News
-
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute. -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance