Friday, June 28, 2013

FDA Trounces Illegal Online Pharmacies

FDAAccording to a news release [here], the U.S. Food and Drug Administration (FDA), in partnership with international regulatory and law enforcement agencies from 99 participating countries, took action against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and more than $41-million worth of illegal medicines worldwide.

The action occurred as part of the 6th annual International Internet Week of Action (IIWA), a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. As part of this year’s international effort — called “Operation Pangea VI” — the FDA’s Office of Criminal Investigations, in coordination with the United States Attorney's Office for the District of Colorado, seized and shut down 1,677 illegal pharmacy websites during June 18-25, 2013.

Many of those websites appeared to be operating as a part of an organized criminal network that falsely purported its websites to be “Canadian Pharmacies.” These websites displayed fake licenses and certifications to convince U.S. consumers to purchase drugs they advertised as “brand name” and “FDA approved.” The drugs confiscated as part of Operation Pangea were not from Canada, and were neither brand name nor FDA approved. These websites also used certain major U.S. pharmacy retailer names to trick consumers into believing an affiliation existed with these retailers.

The FDA’s Office of Criminal Investigations Cybercrime Investigations Unit banner is now displayed on seized websites to help consumers identify them as illegal. Here are some examples:
> http://www.canadianhealthandcaremall.com/
> http://www.walgreens-store.com
> http://www.c-v-s-pharmacy.com

During Operation Pangea VI, the largest Internet-based action of its kind, the FDA targeted websites selling unapproved and potentially dangerous prescription medicines that could pose significant public health risks. Products purchased from the websites targeted during Operation Pangea also bypassed existing safety controls required by the FDA, and the protections provided when used under a doctor’s care.

The goal of Pangea VI, which involved law enforcement, customs, and regulatory authorities from 99 countries, was to identify the makers and distributors of illegal drug products and medical devices and remove those products from the supply chain. Some of the medicines that were sold illegally by the targeted websites included: Avandaryl (glimepiride and rosiglitazone), “Generic Celebrex,” “Levitra Super Force” and “Viagra Super Force,” Clozaril (clozapine), and many others sold as pain relievers, sleep aids, hormone replacement therapies, antidepressants, etc.

In addition to health risks, these illegitimate pharmacies pose non-health-related risks to consumers, including credit card fraud, identity theft, or computer viruses. The FDA encourages consumers to report suspected criminal activity at www.fda.gov/oci. The FDA provides consumers with information to identify an illegal pharmacy website and advice on how to find a safe online pharmacy through BeSafeRx: Know Your Online Pharmacy, plus there is important information for consumers in this regard at Pain-Topics.org [here].

COMMENTARY: The above news release tells the story — and, we would add, “Bravo!” It is time that the worldwide plague of illegitimate online pharmacies is recognized as a form of international terrorism — a growing threat to public health and safety.

Of particular concern for the pain field, the spate of alleged analgesics — including bogus opioids in many cases — proffered by these unscrupulous website operators can be harmful to unwary consumers and it also floods communities with illicit drugs that may be misused and abused. Since the origins of these fugitive drugs are often unknown, they may be erroneously assumed to be diverted from legitimate prescribing and distribution channels; thus tarnishing the reputations of law-abiding prescribers, pharmacies, and wholesalers — as well as patients with pain.

Taking action against nearly 10,000 felonious websites worldwide, as happened this month, sounds impressive; yet, this is a proverbial “drop in the bucket,” since a single offending operation may have hundreds of interconnected sites. It is unfortunate that government funds and resources must be dedicated to chasing down and trouncing these online operations, but it is tax-payer money well spent. The FDA should be commended for these actions in helping to safeguard the public and, in particular, the pain community.

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