Crackdown On Illegal Online Pharmacies Like Playing Internet 'Whack-A-Mole'
Executive Summary
US FDA sends warning letters to online businesses operating a total of 465 websites selling unapproved Rx drugs for indications including breast cancer, chicken pox and pain relief. Warning letters were part of Interpol's annual Operation Pangea against online sales of illegal medical products; this year, US and 115 other countries made 859 arrests worldwide and seized $14m in potentially dangerous pharmaceuticals.
US FDA isn't the only national drug industry regulator attempting to curb online nonprescription sales of unapproved opioid and other Rx drugs. The violations are so rampant, Interpol is coordinating an annual worldwide crackdown.
Shutting down, or ordering a halt to online businesses selling unapproved opioid and other Rx drugs is part of FDA's public health mission, but experts say the activities are like an internet "whack-a-mole" game due to the number of illegal e-commerce pharmacies.
FDA on Oct. 23 announced warning letters to separate online businesses operating a total of 465 websites selling unapproved Rx drugs for indications including breast cancer, viral infections such as chicken pox, and pain relief (see list below). The agency said it sent the warnings as part of the Interpol's annual Operation Pangea to combat the sale and distribution of illegal and potentially counterfeit medical products sold online.
Interpol says police, customs and health regulatory authorities from the US and 115 other countries made 859 arrests worldwide and seized $14m in potentially dangerous pharmaceuticals during its 12th Operation Pangea, Oct. 9-16.
The Singapore-based international police agency said 500 tons of illicit pharmaceuticals were seized worldwide from nearly 1m packages inspected during the week. The operation focused on services "manipulated by organized criminal networks" shut down 3,671 web links, including social media pages as well as online marketplaces.
Results from countries active in the operation included Canada reporting that 87% of the 3,586 packages its customs officials inspected were either seized or refused because they contained counterfeit or unlicensed health products, such as illegal Rx drugs with indications such as blood pressure, erectile dysfunction and cancer and also including nutritional supplements, some of which are regulated as drugs in Canada. The street value of all the illicit products seized or blocked from entry is estimated at around CAD 1.4m ($1.07m).
In Ireland, the Health Products Regulatory Authority said it detained almost 90,000 dosage units of illegal Rx medicines valued at over €375,000 ($430,183) during the latest Operation Pangea. The authority said the units of seized drugs included 29,518 anabolic steroids; 25,241 sedatives; 5,477 analgesics; 5,700 erectile dysfunction products; and 14,009 of other types found in small quantities.
The Irish agency also said that through September, in 2018 it has detained nearly 400,000 dosage units of illegally supplied online medicines valued at €1.39m ($1.6m). Its ongoing action, focused on disrupting supply lines and reducing this type of supply, has taken down 14 social media pages and 10 e-commerce advertisements and has halted sales by 56 websites.
FDA Notes Criminal Cases
FDA has not disclosed details on the number or volume of products seized in its Pangea crackdown.
It noted that its Office of Criminal Investigations initiated multiple criminal investigations involving illegal online pharmacies, including one that led to the recent arrest and indictment of a 31-year-old San Diego woman, Melissa Scanlan, 31, also identified as “The Drug Llama.” Scanlan conducted business on the "dark web" within the internet intended to prevent tracking and identification of users. In an indictment filed in September in US District Court for Southern Illinois, she was accused of shipping more than 50,000 fentanyl tablets around the US.
URLs State Sites' Intent
The latest online pharmacies warned by FDA operate with names such as "Farma Glow" and "MyRxAffiliate Program." The seven operators FDA warned in letters submitted earlier in October use descriptive internet addresses such as "royalrxdrugs.com," "yourmedicinesrxxx24.com," "kingdompills.com" and "all‐rxcenters365.ru."
None of the warnings included addresses for the businesses. The website addresses ending with ".ru," indicate a Russian registration.
The agency also reported that its 2018 Pangea work closed an investigation that started in 2012. FDA warning letters sent to a firm identified as "Canada Drugs Online Pharmacy Network" were ignored. But as the result of an an OCI investigation, Kristjan Thorkelson, of Manitoba, Canada, pled guilty in April 2018 too charges of illegal sales of misbranded and counterfeit prescription drugs in the US via Canada Drugs Network as well as other companies. Thorkelson was sentenced to a $250,000 fine and a five-year probation and ordered to permanently cease illegal operations, surrender to the US thousands of domain names and websites from the businesses and to cooperate with the Department of Justice and FDA in criminal investigations.
"Today’s major operation by FDA, together with our international regulatory and law enforcement partners, demonstrates that we’ll aggressively pursue those who place patients at risk and seek to profit from illegal products,” said FDA Commissioner Scott Gottlieb.
In 2017, FDA announced a series of crackdowns on online pharmacies. The most recent, in August 2017, highlighted products formulated with the opioid ingredient tramadol. (Also see "OTC Tramadol Sales By 21 Online Pharmacies Found In US FDA Sweep " - Pink Sheet, 28 Aug, 2018.)
FDA said the warning letters it announced in June 2017 marked the start of it enforcement to rein in e-commerce "virtually awash in illegal narcotics." (Also see "Opioid Drug Sales Online Draw US FDA Warnings, Prompt Summit Meeting" - Pink Sheet, 5 Jun, 2018.)
One Closes, Dozens Remain Unknown
Disclosing details on seizures from the warned businesses might add little significance to FDA's report. While the crackdown is part of the agency's public health mission, for every website it stops at least dozens more still are operating, including additional, unknown online addresses operated by businesses that FDA warns about sites it has found.
"It is this type of action that will likely yield results but how significant is difficult to judge. The internet and globalization simply makes it difficult to police everyone and it often times appears to be nothing more than whack-a-mole so I believe FDA is doing the right thing in coordinating its actions," said attorney Todd Harrison, chair of Venable LLP's FDA practice in Washington.
Harrison added that illegal online pharmacies quickly regroup under different guises. That capability renders FDA's enforcement effective in the short term but not so in the long term.
"It is similar to the war on drugs. As long as people are willing to buy, there will be people willing to sell. The problem is you do not know what you are really buying," he said.
The Center for Science in the Public Interest also sees the crackdown as a small step in the right direction. "The problem is that they're dealing with a massive problem," said Peter Lurie, the public health advocacy group's president.
"In effect, they're playing cyber whack-a-mole with these companies. All the same, it's worthwhile to take action against the worst offenders, which clearly includes the opioid sellers, as a message to the larger community of illegal online pharmacies," Lurie said in an interview.
Long-Term Play Of Shorter-Term Scams
FDA's warning letter submitted to each of the seven online operations does not state an address, a registered company name or the name of a person identified as a principal for a firm. Those omissions could be a sign that the warnings might not resonate with the targets.
"I suppose they're counting on those companies who live on the web to be cooperative," Lurie said.
On the other hand, that type of information for some online operators can be elusive. "The absence of the names underscores the difficulty in bringing enforcement actions in these cases. It also underscores the fact that these companies operate in a virtual world," Lurie said.
Illegal online sales of opioid and other drugs appear to be an long-term problem of the type that typically occur for short periods, when FDA and regulators in other countries find bogus online offers of remedies during health scares, such as an emerging virus. (Also see "Fraudulent Zika Claims Are CDER's Latest Extermination Target" - HBW Insight, 13 Jun, 2016.)
And the online businesses selling those products likely are the same operators targeted in the recent Interpol-coordinated crackdown.
"These people are so nimble and so creative, the FDA really faces an uphill battle here. As sure as there will be a new health crisis, you can predict that these things will pop up on the internet," Lurie said.