FDA Issues 22 Warning Letters to Web site Operators

The U.S. Food and Drug Administration today completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.

During the effort, the FDA’s Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. In many cases, because of these violations, Internet service providers and domain name registrars may have grounds to terminate the Web sites and suspend the use of domain names.

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

The IIWA is an initiative sponsored by the International Criminal Police Organization, the World Health Organization's International Medical Products Anti-Counterfeiting Task Force, the Permanent Forum on International Pharmaceutical Crime, and national health and law enforcement agencies from 26 participating countries.

The goal of the IIWA is to protect public health by:

* increasing the public's awareness about the dangers and risks associated with purchasing drugs and medical devices from Web sites
* identifying producers and distributors of counterfeit and illegal pharmaceutical products and medical devices
* targeting these individuals and businesses with civil or criminal action
* seizing counterfeit and illegal products and removing them from the supply chain.

Code named Operation Pangea II, the IIWA provided an opportunity to enhance cooperation among international and domestic regulatory and law enforcement partners to effectively act against those involved in the manufacture and distribution of illegal medications.

During the week, OCI and FDA import specialists joined with Immigration and Customs Enforcement, Customs and Border Protection, the Drug Enforcement Administration, and the U.S. Postal Inspection Service to target and interdict shipments of violative pharmaceutical products moving through certain International Mail Facilities (IMFs) and express courier hubs.

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