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Consumer Affairs

FDA Cracks Down on Web Sites Selling Unapproved Drugs

136 operators get warnings on their activities


By James Limbach
ConsumerAffairs.com

November 20 2009
The Food and Drug Administration has sent 22 warning letters to the operators of 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 FDA action was part of a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.

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

"Many U.S. consumers are being misled in the hopes of saving money by purchasing prescription drugs over the Internet from illegal pharmacies," said FDA Commissioner Margaret A. Hamburg, M.D. "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 24 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, the FDA's Office of Criminal Investigations and agency 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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