Inspections, Compliance, Enforcement, and Criminal Investigations
September 29, 2011: FDA Participates in Global Efforts to Protect Consumers and Patients From Unsafe Drugs on the Internet
The U.S. Food and Drug Administration and other regulatory and international partners have completed the International Internet Week of Action (IIWA), a cooperative effort to curb online sales and distribution of counterfeit and illegal medical products.
This year’s IIWA, which ran between Sept. 20 and Sept. 27 is called OPERATION PANGEA IV, focused on websites supplying illegal and dangerous medicines. The operation is the largest Internet-based action of its kind in support of the International Medical Products Anti-Counterfeiting Taskforce.
The goal of the IIWA is to protect the public health by increasing the public’s awareness about the dangers and risks associated with purchasing medicines and medical devices from websites, to identify the producers and distributors of counterfeit or otherwise illegal pharmaceutical products or medical devices, to target these individuals or businesses with civil or criminal action, and to seize counterfeit and illegal products and remove them from the supply chain.
“The FDA will continue to work closely with our domestic and international law enforcement and regulatory partners to protect consumers from unapproved and potentially harmful products sold over the internet,” said Dara Corrigan, associate commissioner for regulatory affairs. “We will continue to aggressively pursue those who sell products which may pose a significant risk to consumer health.”
The IIWA also provided an excellent opportunity for the FDA to enhance cooperation with international and domestic regulatory and law enforcement partners to effectively target those involved in the manufacture and distribution of illegal medicines.
FDA’s Office of Criminal Investigations, in conjunction with the Center for Drug Evaluation and Research, and the Office of Enforcement targeted 997 websites that are engaged in the illegal sale of unapproved and/or misbranded medicines to U.S. consumers.
During OPERATION PANGEA IV, FDA focused its efforts on websites selling unapproved drugs, such as drugs containing human growth hormone (HGH), sildenafil citrate, or isotretinoin. These unapproved drugs can be detrimental to public health. Although some drugs containing these active ingredients are approved by FDA for use under the supervision of a licensed medical practitioner, the drugs offered for sale on these websites were not FDA approved, and were offered for sale without requiring a valid prescription.
Improper use of HGH can lead to side effects, including an increased risk of cancer, nerve pain, and elevated cholesterol or glucose levels. Sildenafil citrate tablets are used to treat erectile dysfunction and should not be used in some consumers with heart problems. Isotretinoin capsules, previously marketed as Accutane in the United States, are used to treat severe nodular acne. The drug carries significant potential risks, including severe birth defects if pregnancy occurs while using this medicine.
To minimize potential risks, FDA approved isotretinoin capsules are only available through restricted distribution in the United States, and patients purchasing unapproved products containing this active ingredient are placed at a higher risk because, among other issues, they bypass existing safety controls.
The FDA sent Warning Letters to the operators of the identified websites, all of which appear to be associated with the same individuals and corporate entities located outside of the United States.
As a follow up, the agency sent notices to the Internet Corporation for Assigned Names and Numbers, Registries, Internet Service Providers (ISPs), and Domain Name Registrars (DNRs) informing them that these websites were selling products in violation of U.S. law.
In many cases, conducting illegal activities also violates ISP and DNR policies and agreements, giving the hosting companies the opportunity to terminate the websites and suspend the use of the domain names. Of the 717 websites addressed in the Warning Letters, a total of 578 have been suspended or no longer offer pharmaceuticals for sale. The FDA is working with its foreign counterparts to address the remaining websites, which continue to offer unapproved or misbranded prescription medicines to U.S. consumers.
The FDA encourages consumers to report suspected criminal activity at www.fda.gov/oci
The IIWA is a coordinated effort by INTERPOL, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, the Heads of Medicines Agencies Working Group of Enforcement Officers, as well as national health and law enforcement agencies from 81 participating countries.
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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, products that give off electronic radiation, and for regulating tobacco products.