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"I represent safe and affordable imported medication. This bathwater is dangerous rogue pharmacy sites!"

“I represent safe and affordable imported medication. This bathwater is dangerous rogue pharmacy websites!”

Earlier this month, the U.S. Food and Drug Administration published a press release about Operation Pangea, an annual global initiative led by INTERPOL “to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products on the internet.” This is the ninth annual operation, and each year I wonder if FDA will throw the baby out with the bathwater.


There are, according to FDA’s own sources, tens of thousands of drug-selling websites. Most of them are considered “rogue” by Where the FDA and Operation Pangea successfully shut down sites (whether lawful or not) that intentionally sell counterfeit medications, or even online pharmacies that sell real medications but without the qualifications or pharmacy safety protocols to do so, we applaud their actions. Shutting down dangerous online pharmacies – throwing out the bathwater – is noble.

In February of last year we submitted a policy paper that I wrote to congressional committees with jurisdiction over laws and regulations that affect access to safe and affordable medications. Entitled “Online Pharmacies, Persona Drug Importation, and Public Health,” I argued that safe international online pharmacies are a boon to public health because they enable consumers to afford prescribed medications, and that overzealous enforcement of drug importation regulation could negatively affect access to those sites. Actions taken by FDA and through Operation Pangea would seem to cross the line from public health to Big Pharma profit protection where they curtail access to the safest international online pharmacies, which is throwing out the baby.

So did they throw out the baby with the bathwater? I don’t know but I don’t think so. FDA writes that it took action against 4,402 websites that “illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers.” In these cases, they contacted domain registrars – the companies that license website names – asking them to take down those sites. They also write that they sent warning letters to 53 websites “illegally offering unapproved and misbranded prescription drug products for sale to U.S. consumers.”

Here’s the thing: Even the prototype of the safest international online pharmacy selling to consumers in the U.S., say a licensed pharmacy in Manitoba, Canada that is expressly permitted by law to sell medications internationally, requires a valid prescription, and practices mail-order pharmacy in accordance with the highest global standards, could be swept up into this enforcement action. Why? How could that be? Here’s one reason: When a lawfully manufactured, safe and effective medication produced in a U.S. FDA registered manufacturing plant is labelled differently than the exact same medication sold here –it’s deemed MISBRANDED. In other words, lawfully and ethically operating international pharmacies, whether in Canada, the U.K., India or Turkey, are potentially impacted by Operation Pangea due to unjust U.S. drug importation laws.

Should we blame FDA for those laws? No. Those laws are the responsibility of Congress and the product of a pharmaceutical lobbying leviathan.

As I learn more about how FDA actually works, I realize that the FDA can use common sense and humanitarian discretion in the enforcement of federal regulations – and it often does. But FDA can also overreach…

But as far as I’m aware, the safest international online pharmacies, which are those found in the Verification Program, are still online and able to serve consumers, wherever they are, who need affordable and safe medication. Rock-a-bye baby.

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