Inspections, Compliance, Enforcement, and Criminal Investigations
June 27, 2013: Colorado U.S. Attorney's Office, in Cooperation with the Food and Drug Administration, Seizes Over 1,600 Websites Selling Counterfeit or Misbranded Medication
DENVER – U.S. Attorney John Walsh announced today that the Colorado U.S. Attorney’s Office, as part of International Internet Week of Action, and in conjunction with Interpol’s Operation Pangea VI, obtained seizure warrants in the United States District Court for the District of Colorado in Denver for over 1,600 websites that were illegally selling counterfeit or misbranded drugs purported to be brand name pharmaceuticals. The seizure of those sites was executed by the Food and Drug Administration’s Office of Criminal Investigations last week.
Many of these websites operated as a part of an online network of pharmaceutical sites, which falsely purported that its websites were legitimate online pharmacies. Many of these sites falsely claimed to be hosted in Canada, while others falsely claimed to be affiliated with major U.S. pharmacy retailers by using the names of those retailers in the website names. The organizers also used bogus licenses and certifications in an attempt to convince U.S. consumers to purchase drugs that the sites falsely advertised as “brand name” and “FDA Approved.” Drugs purchased from these sites proved not to be from Canada, and they were neither brand name drugs nor were they FDA approved. The shipments originated from either India or Singapore. The FDA’s Office of Criminal Investigations Cybercrime Investigations Unit banner is now displayed on all seized 1,677 websites to alert consumers that the sites were identified as engaging in illegal activity. Below is a list of three of the website names seized:
Medications offered and sold by these websites included the following: Avandaryl (a diabetes and heart drug), Celebrex (a non-steroidal anti-inflammatory product used to treat arthritis and to manage pain), Levitra and Viagra (erectile dysfunction drugs), and Clozapine (a severe schizophrenia medication).
“Ordering a prescription medication from a website that doesn’t require a prescription is dangerous,” said Colorado U.S. Attorney John Walsh. “That’s both because a doctor’s authorization and supervision is important, but also because overseas drug manufacturers may not be complying with FDA safety rules. The sites seized as a part of this important operation were selling drugs manufactured overseas without FDA supervision to people who didn’t necessarily have prescriptions, and who can’t be sure they are actually receiving the drug they thought they were ordering. Thanks to the hard work of the FDA Office of Criminal Investigations and the Assistant U.S. Attorneys from the District of Colorado, over 1,600 websites have been shut down ensuring that the public does not accidentally purchase a counterfeit or misbranded drug.”
“Protecting U.S. consumers is the agency’s top priority. We know that illegal online pharmacies put U.S. consumers’ health at risk,” said John Roth, Director of the FDA’s Office of Criminal Investigations. “While this is an ongoing battle in the United States and abroad, the agency nonetheless will not cease its criminal law enforcement and regulatory efforts and is pleased to participate in Operation Pangea to protect consumers and strengthen relationships with international partners who join the FDA in this fight.”
During Operation Pangea VI, the largest Internet-based action of its kind in the United States, the U.S. Attorney’s Office for the District of Colorado and the FDA targeted websites selling unapproved and potentially dangerous prescription medicines that could pose significant public health risks. These medicines should only be used with a valid prescription and under the supervision of a licensed health care provider. In addition, these online-purchased products bypass existing safety controls required by the FDA, and protections provided when used under a doctor’s care.
In addition to health-related risks, members of the public who used these websites also potentially exposed themselves to financial risks, including credit card fraud, identity theft or computer viruses. If you believe you have been a victim of these websites please visit www.fda.gov/oci.
The United States portion of this investigation was handled by the FDA’s Office of Criminal Investigations.
Assistant U.S. Attorneys Tonya Andrews, Ken Harmon and Judith Smith, chief of the Special Prosecutions Section, assisted in obtaining the seizure warrants.