by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Nov 16, 2018 | Big Pharma
This week, I attended ASOP Foundation’s symposium titled: “Spotlight on Illegal Online Sales of Medicine.” ASOP is short for the Alliance for Safe Online Pharmacies. That organization, which started with funding from Eli Lilly and the National Association of Chain Drug Stores, has often received criticism on these blog pages. Like other Pharma-funded initiatives, its goals are aligned with the pharmaceutical industry and one of its main objectives is lobbying against personal drug importation. It often conflates, through its public education programs, safe international online pharmacies with dangerous rogue websites. However, a good part of its work is helping raise awareness and policy development to stop rogue sellers of counterfeit and substandard medicines from harming patients, and that’s something PharmacyChecker is 100% behind.
Much of ASOP’s work was the brainchild of LegitScript, a founder of ASOP. Truth be told, PharmacyChecker is the expert in safe international online pharmacies and providing consumers with useful guidance about them, but LegitScript/ASOP are the experts in rogue online pharmacies and pushing policies to shut them down. It’s disheartening that they seemingly refuse to separate safe importation from rogue online drug sellers. But I’ll put that aside for now.
I’m going to focus today’s post mostly on presentations by two high-ranking FDA officials. The first was the morning’s keynote speaker, Donald Ashley, JD, FDA’s Center for Drug Evaluation and Research Director of Compliance. His focus was the FDA’s efforts to combat illegal opioid sales online and those being imported through international mail facilities. I’ve written about how such actions can be used against safe personal drug imports. While that would be unfortunate, Mr. Ashley was meticulous in communicating that his efforts are strictly focused on opioids: shutting down fentanyl and other opioid-selling sites; detecting and stopping illegal opioid imports; and, through the Office of Criminal Investigations, charging and prosecuting these online opioid drug dealers.
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Tagged with: Alliance for Safe Online Pharmacies, U.S. Food and Drug Administration
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Nov 7, 2018 | FDA enforcement
The FDA’s recent press release announcing its activities in Operation Pangea XI, an enforcement operation to “crack down on websites selling illegal, potentially dangerous drugs; including opioids,” is conspicuously inaccurate about CanadaDrugs.com, which was forced to close its operations back in July. For a more general analysis of Operation Pangea XI, see my post from last week.
CanadaDrugs.com vs. CanadaDrugs
CanadaDrugs.com was the biggest Canadian online pharmacy for well over a decade. During its 17 years in business, it estimated that people ordered one billion dollars in medicines. During that time, not a single adverse reaction was ever reported by the FDA or any health agency. Their business relied on the fact that Americans are never prosecuted for personal drug importation. The law permits, and Congress has recognized the importance of, the FDA using enforcement discretion to allow personal drug imports so people can afford medicine.
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Tagged with: canadadrugs, Enforcement, Operation Pangea
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Nov 1, 2018 | FDA enforcement
Last week, the FDA reported on its enforcement efforts against illegal and “potentially dangerous” online drug sales in Operation Pangea XI, a global initiative run by INTERPOL in cooperation with over one hundred drug regulators. Also, President Trump signed H.R. 6, The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. I wish it was all about stopping rogue online pharmacies and ending the opioid crisis, but it’s not.
How Pangea XI and the SUPPORT Act are Related
The FDA is highlighting the SUPPORT Act and its effort in Pangea as important parts of the solution to stopping illegal online sales of addictive opioid drugs. The SUPPORT Act gives the FDA new authorities to stop illegal drug imports. So, what does this have to do with safe personal drug importation from pharmacies that require a prescription?
Before continuing, I can’t help note and show you that INTERPOL’s Pangea is funded by drug companies for this work. It’s this Pharma-funded initiative in which FDA plays a crucial role. The FDA does focus resources on shutting down some bad rouge sites, but it seems to also assist PhRMA in ways that curtail online access by Americans to lower-cost medicines from pharmacies in other countries.
There seems to be a tug of war: FDA’s enforcement efforts against safe personal imports vs. FDA’s lawful use of enforcement discretion to allow safe personal imports.
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Tagged with: Enforcement, Interpol, Operation Pangea, opioid
This week, I attended ASOP Foundation’s symposium titled: “Spotlight on Illegal Online Sales of Medicine.” ASOP is short for the Alliance for Safe Online Pharmacies. That organization, which started with funding from Eli Lilly and the National Association of Chain Drug Stores, has often received criticism on these blog pages. Like other Pharma-funded initiatives, its goals are aligned with the pharmaceutical industry and one of its main objectives is lobbying against personal drug importation. It often conflates, through its public education programs, safe international online pharmacies with dangerous rogue websites. However, a good part of its work is helping raise awareness and policy development to stop rogue sellers of counterfeit and substandard medicines from harming patients, and that’s something PharmacyChecker is 100% behind.
