Websites Selling Unapproved Drugs in US

Last week, the U.S. Food & Drug Administration completed an international, coordinated effort to curb the online selling of illegal medical products and pharmaceuticals. The FDA titled the campaign the International Internet Week of Action (IIWA) and gave the code name Operation Pangea II. The FDA’s Office of Criminal Investigations (OCI), the Center for Drug Evaluation and Research, and the Office of Enforcement targeted 136 websites that appeared to be participating in and promoting the illegal sale of misbranded and unapproved drugs to those consumers within the U.S. borders. In total, the effort found that 22 websites were selling medical products in violation of U.S. law. Warning letters were sent to the operators of these websites. In addition, the agency notified Internet service providers and registrars that these sites were participating in illegal activity. Because of these violations, the providers may have legitimate grounds for terminating the websites and suspending the use of the domain names. In addition, OCI and FDA import specialists targeted and disrupted shipments deemed in violation. Many of the products were moving through express courier hubs and International Mail Facilities. Shipments were confiscated and removed from product lines. Margaret A. Hamburg M.D., the FDA Commissioner, stated that “the FDA works in close collaboration with our regulatory and law enforcement counterparts in the United States and throughout the world to protect the public” and that “many U.S. consumers are being misled in the hopes of saving money by purchasing prescription drugs over the Internet from illegal pharmacies. Unfortunately, these drugs are often counterfeit, contaminated, or unapproved products, or contain an inconsistent amount of the active ingredient. Taking these drugs can pose a danger to consumers.”

What were the goals of the IIWA? The primary goal is to protect the public health of consumers. Secondly, they want to increase the public’s awareness about the risk associated with purchasing drugs and medical products from websites. Third, they want to identify various distributors and producers of counterfeit pharmaceutical products. Fourth, bring forth civil or criminal action to those individuals and businesses associated with the illegal sale of medical products. And finally, the IIWA needs to remove such illegal products from the supply chain to maintain the integrity of the product line.

The coordinated effort provided an opportunity to enhance cooperation among international and domestic partners. A host of regulatory and law enforcement agencies went forth to act against those persons involved in such activity. The list of participating agencies is impressive and noteworthy. In total, agencies from 24 countries participated in the investigation.

• The International Police Organization
• WHO’s International Medical Products Anti-Counterfeiting Task Force
• Permanent Forum on International Pharmaceutical Crime
• Immigration and Customs Enforcement
• The Drug Enforcement Administration
• The U.S. Postal Inspection Service
• Other various national health and law enforcement agencies

So, where is the impact to us? In the ever growing world of Internet based services and the ability to easily access particular products, we must recognize that individuals and businesses are still, at the core, self interested beings. Many strive to make a profit off the vulnerability of many consumers. Illegal activity is rampant among Internet sites and it is our responsibility to be smart consumers. We our responsible for our health, our lives, our future, and our loved ones. If you purchase drugs, medical supplies, pharmaceuticals, supplements, or other related products online:

• Do your homework!
• Research the company and ask questions
• Don’t be afraid to pick up the phone!
• Check with the Better Business Bureau (www.bbb.org)
• Contact your primary physician for options
• Ask friends and family members
• Make smart decisions

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