Agency participates in international Operation Pangea V to protect consumers from potentially dangerous, unapproved drugs

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites.

The announcement takes place during the 5th annual International Internet Week of Action (IIWA), 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.

“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,” said FDA Commissioner Margaret A. Hamburg, M.D. “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.

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for use only under the supervision of a licensed health care practitioner or active ingredients that were previously withdrawn from U.S. market due to safety issues.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 breastfeeding 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.
• 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 health care professional may not learn about potential drug interactions, such as increased blood pressure lowering effects of organic nitrates when taken with sildenafil citrate.

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 (ISPs), and domain Name Registrars (DNRs) 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,” said 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.”

The FDA coordinated the efforts of this year’s Operation Pangea V, including screening all drug products received through the international mail facilities during the IIWA. Preliminary findings showed that certain products from abroad, such as antibiotics, antidepressants, and other drugs to treat high cholesterol, diabetes, and high blood pressure, were on the way to U.S. consumers. Many of those products can pose health risks if taken without the supervision of a health care practitioner or if the products have been removed from the market for safety reasons.

The FDA encourages consumers to report suspected criminal activity at www.fda.gov/oci.

The IIWA is a collaboration between FDA, INTERPOL , the World Customs Organization, Permanent Forum of International Pharmaceutical Crime, Heads of Medicines Agencies Working Group of Enforcement Officers, the Medicines and Healthcare products Regulatory Agency of the United Kingdom, the Irish Medicines Board, the London Metropolitan Police, the U.S. Department of Homeland Security, the Center for Safe Internet Pharmacies, and national health and law enforcement agencies from 100 participating countries.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.