SILVER SPRING, Md. — In partnership with international regulatory and law enforcement agencies, the Food and Drug Administration on Thursday announced it had taken action against more than 4,100 Internet pharmacies that illegally sell unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products and removal of offending websites.
“Consumers in the United States and around the world face a real threat from Internet pharmacies that illegally sell potentially substandard, counterfeit, adulterated or otherwise unsafe medicines,” stated FDA Commissioner Margaret Hamburg. “This week’s efforts show that strong international enforcement efforts are required to combat this global public health problem. The FDA is committed to joining forces to protect consumers from the risks these websites present.”
Last week, the FDA reinforced its online efforts with the launch of a national campaign to educate Americans about the risks of buying prescription medications over the Internet. BeSafeRx – Know Your Online Pharmacy seeks to raise public awareness about the health risks of using fraudulent Internet pharmacies and what consumers can do to protect themselves.
The announcement takes place during the fifth annual International Internet Week of Action, a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. This year’s effort, Operation Pangea V, operated between Sept. 25 and Oct. 2 and resulted in the shutdown of more than 18,000 illegal pharmacy websites and the seizure of about $10.5 million worth of pharmaceuticals worldwide.
The goal of this annual effort — which involved law enforcement, customs and regulatory authorities from 100 countries — is to identify producers and distributors of illegal pharmaceutical products and medical devices and remove these products from the supply chain.
During Operation Pangea V, the FDA targeted websites selling unapproved and potentially dangerous medicines. In many cases, the medicines can be detrimental to public health because they contain active ingredients that are approved by FDA for use only under the supervision of a licensed healthcare practitioner or active ingredients that were previously withdrawn from U.S. market due to safety issues.
Among the illegal medicines identified through the operation were:
Domperidone: This medicine was removed from the United States market in 1998 because it may cause serious adverse effects, including irregular heartbeat, stopping of the heart or sudden death. These dangers could convey to the nursing baby of breast-feeding women, who may be using domperidone to try increase milk production, which is not an approved use;
Isotretinoin (previously marketed as Accutane in the United States): This medicine is used to treat severe nodular acne and carries significant potential risks, including severe birth defects if pregnancy occurs while using this medicine. To minimize potential risks to consumers, FDA-approved isotretinoin capsules are only available through restricted distribution in the United States;
Tamiflu (oseltamivir phosphate): This medicine, which is used to treat the flu, is often sold online as “generic Tamiflu.” However, there is no FDA-approved generic version of Tamiflu. Previous FDA tests found that fraudulent versions of “generic Tamiflu” contained the wrong active ingredient, which would not be effective in treating flu. In these cases, the wrong active ingredient was similar to penicillin and may cause a severe allergic reaction, including a sudden, potentially life-threatening reaction called anaphylaxis, in consumers allergic to penicillin products; and
Viagra (sildenafil citrate): This medicine is used to treat erectile dysfunction. Due to its vasodilation effects, sildenafil citrate should not be used by consumers with certain heart conditions. Consumers taking this medicine without the supervision of a healthcare professional may not learn about potential drug interactions, such as increased blood pressure-lowering effects of organic nitrates when taken with sildenafil citrate. Many Web entities illegally market these products as dietary supplements.
The FDA sent warning letters to the operators of more than 4,100 identified websites. As a follow-up, the agency sent notices to registries, Internet service providers and domain name registrars informing them that these websites were selling products in violation of U.S. law. The FDA is working with its foreign counterparts to address the remaining websites that continue to offer unapproved or misbranded prescription medicines to U.S. consumers.
“Internet pharmacies that illegally sell unapproved, counterfeit or potentially adulterated or substandard drugs are an inherently international crime problem,” stated John Roth, director of the FDA’s Office of Criminal Investigation. “The FDA is pleased to work with Interpol, the international police agency, to fight this problem. Because these criminals do not respect international borders, the international coordinated law enforcement response represented by Operation Pangea demonstrates that international cooperation is the best way to protect the American public from the risk of unsafe drugs.”