Battle fronts in the illicit online pharmacy war

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Pharmaceutical CommercePharmaceutical Commerce - July/August 2016

The annual Operation Pangea nets a next crop of crooks; consumer groups raise awareness

online pharmacy war

Fake drugs being smuggled inside a car were intercepted in Hungary under Operation Pangea IX. Source: Interpol

Pangea IX, this year’s effort to police the distribution of fake or illicit drugs, and the websites that promote them to unwitting consumers, concluded on June 7. According to press statements from FDA and Interpol, the international police organization, the takedown this year included suspending 4,932 websites, seizure of $53 million worth of potentially dangerous medicines, 393 arrests worldwide and the launching of 700 more investigations that could lead to further arrests.

Operation Pangea IX was coordinated by Interpol with support from the World Customs Organization (WCO), the Permanent Forum of International Pharmaceutical Crime (PFIPC), the Heads of Medicines Agencies Working Group of Enforcement Officers (WGEO), Europol, the Pharmaceutical Security Institute (PSI), the Center for Safe Internet Pharmacies (CSIP) and private sector companies including Discover, G2, LegitScript, MasterCard, PayPal and VISA. The latter three organizations, members of the Center for Safe Internet Pharmacies, are involved because e-commerce transactions from the illicit websites often involve their payment clearance systems; that Center is also supported by some of the leading web search engines, such as Google and Bing (but not, it’s worth noting, China’s Alibaba; China is widely recognized as the source of much of the fake medicine circulating in the world).

Pangea and related enforcement activities are part of a never-ending process of trying to regulate the distribution and sale of fake, adulterated or illicitly marketed drugs. In the developed world, drug-traceability systems like the US’ Drug Supply Chain Security Act, or Europe’s Falsified Medicines Directive, will tighten global supply chains but not close off the illicit activities. Interpol noted in its press statement that at least 40 of the ongoing investigations point to organized crime as participants.

LegitScript produced a report for the Center for Safe Internet Pharmacies back in January, summarizing current activities and projecting future trends.* It noted that restrictions on broad online advertising through search engines has been mostly successful; rogue pharmacies are gravitating toward social media where such restrictions are not as effective. In terms of what is being marketed, there’s a shift toward synthetic cannabinoids and psychoactive “designer drugs” (which are formulated to get around restrictions on specific chemicals, and which continually change their composition); and the practice of “affiliate marketing,” where individual webmasters serve as conduits to a centralized ordering service, toward a more organized network of domain registrars that allow the illicit practices and webmasters more closely affiliated with the drug providers. Looking ahead, LegitScript predicts that the number of rogue pharmacies will continue, with 30,000 or so domains that are connected to 125–150 providers. The range of activity of illicit pharmacies has tightened (another factor is the success that the National Assn. of Boards of Pharmacy has had with controlling the “.pharmacy” domain name—only verified online pharmacies can use that domain extension); but they are far from disappearing.

Public education

“An educated consumer is our best customer,” an advertising slogan from a New York retailer in past years, could be adopted with benefit by the Alliance for Safe Online Pharmacies (ASOP), which launched a public education campaign in early June to highlight both the importance of the dot-pharmacy domain, and to make consumers—especially the elderly—more aware of the risks of the too-good-to-be-true bargains seen there. Besides producing an educational website (www.XtheRisk.com), the organization has linked with the National Consumers League to raise awareness through public-service announcements. CSIP is sharing these goals and joining in the effort, and one of the CSIP members, Visa Inc., has just joined ASOP.

“While the vast majority of e-commerce merchants operate legitimate businesses, we recognize the threat presented by illegal online pharmacies that endanger public health and erode trust in the payment system by selling consumers counterfeit drugs,” said Martin Elliott, global head of brand protection for Visa, in a statement. “We are proud to join ASOP Global to protect cardholders and the integrity of electronic payments systems.”

FedEx is exonerated

Another front in the regulatory battle over online pharmacies was the Dept. of Justice/FDA litigation over FedEx’s handling of online pharmacy orders. A years-in-the-making criminal prosecution against FedEx for the controlled-substances shipments that flowed through its network in the early 2000s collapsed on June 17, as federal prosecutors filed a request to dismiss all charges. An AP report of the development, noting that this was a non-jury trial, said that the judge called FedEx “factually innocent,” according to trial transcripts. Had the case resulted in a verdict, FedEx could have been at risk for a $1.8-billion fine.

The case opened on Monday, June 13; the original charges were made in 2014, and recounted incidents going back to the early 2000s of shipments being made to suspect online pharmacies—even to individual drug users. FedEx aggressively maintained its innocence at the time. The year before, UPS had settled similar charges with the Dept. of Justice and paid a $40-million fine as part of a “non-prosecution agreement.”

“FedEx is and has always been innocent,” said Patrick Fitzgerald, FedEx SVP, marketing and communications, in a statement. “The case should never have been brought. The government should take a very hard look at how they made the tremendously poor decision to file these charges. Many companies would not have had the courage or the resources to defend themselves against false charges. The power of the government was greatly misused when the case was initiated, but the government’s integrity was redeemed by the decision to dismiss the charges today.”

Earlier this spring, Congress passed the Ensuring Patient Access and Effective Drug Enforcement Act, which, among other things, calls for better coordination between the Drug Enforcement Administration 
and legitimate drug distributors. That ought to make disputes like the FedEx case a rarity.

*http://www.safemedsonline.org/wp-content/uploads/2016/01/The-Internet-Pharmacy-Market-in-2016.pdf

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