The following article appeared in Drug Industry Daily.

Global regulatory agencies seized more than $41 million worth of counterfeit and illicit drugs and blocked 1,677 fake pharmacy websites as part of a large internet-based enforcement action.

The dragnet continues to expand each year, with this year’s spring sting coming two seasons ahead of schedule and far outpacing the previous crackdown, which netted an estimated $10.5 million in fake pharmaceuticals (DID, Oct. 5, 2012).

Dubbed Operation Pangea VI, the effort ran from June 18-25 and involved law enforcement, customs and regulatory authorities from 99 countries. The sting resulted in action being taken against 9,600 websites that illegally sell potentially dangerous, unapproved drugs.

Many of the seized websites appeared to be operating as a part of an organized criminal network that falsely purported its websites to be Canadian pharmacies, the FDA said Thursday. The websites displayed fake licenses and claimed to sell brand-name and “FDA-approved” products.

A 2005 agency operation found that nearly half of the imported drugs the FDA intercepted from four selected countries were shipped to fill orders that U.S. consumers believed they were placing with “Canadian” pharmacies. Of the drugs being promoted as such, 85 percent actually came from 27 countries around the globe, and many were counterfeit (DID, Aug. 31, 2006).

The websites seized in the latest sting also used major U.S. pharmacy retailer names to trick consumers into believing an affiliation existed with the fake pill peddlers. The FDA’s Office of Criminal Investigations Cybercrime Investigations Unit banner is now displayed on the websites.

During the operation, the FDA encountered sales of unapproved versions of Celebrex (celecoxib), misleadingly marketed on these sites as a generic, and clozapine, a treatment for severe schizophrenia associated with potentially fatal drops in white blood cell counts. To minimize risks, consumers who are prescribed the FDA-approved version of the drug, Clozaril, are required to enroll in a registry that ensures regular monitoring of their blood counts.

Sales of Viagra (sildenafil citrate) without requiring a valid prescription continue to be rampant.

The collaborative crackdown involved INTERPOL, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime and various pharmaceutical companies. Drugmakers earlier this year announced a $5.8 million team-up with INTERPOL to battle counterfeit drugs (DID, March 14). The three-year program will focus on the prevention of all types of pharmaceutical crime, including brand- and generic-drug counterfeiting as well as identifying and dismantling of organized crime networks.

The Center for Safe Internet Pharmacies, a coalition of major internet players such as Google, Microsoft, PayPal and various credit providers, also took part, responding to law enforcement requests to shut down suspect websites’ payment portals or to pull advertisements. “From our understanding, the very prolific sites are coming from a small number of criminal networks,” Marjorie Clifton, the group’s executive director, said Thursday. While unable to provide metrics to show that Pangea’s efforts have proven to be fruitful year-on-year, she emphasized the operation’s “imperative” strategy and relative success at targeting the problem from the roots up. — Melissa Winn