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Is the FDA Summit about Online Opioid Sales or Opposing Drug Importation?

Americans censored from affordable insulin

For years, the pharmaceutical industry and the FDA have used the global problem of counterfeit drugs to lobby against importation of lower-cost prescription medicines. They have used the online sale of controlled drugs without a prescription as a pretext to curtail online access to licensed pharmacies in Canada. And now they’re using the opioid addiction and overdose crisis as well. So, when I learned that there will be a meeting hosted by the FDA, a “Summit” to address the problem, my radar went up. What is this really about, and who has a seat at the table?

The event is called “FDA Online Opioid Summit: Reducing Availability of Illicit Opioids Online.” I have no doubt that the participants genuinely want to stop illegal opioid sales on social media sites and rogue pharmacy sites, but Panel #1 is essentially the usual pharma suspects from the Alliance for Safe Online Pharmacies, who spent about half a million bucks lobbying Congress to stop prescription importation legislation that doesn’t even allow imports of controlled substances at all. Since 2009, that group has been pushed by Eli Lilly on the Obama administration to shut down safe international pharmacies under the guise of going after rogue sites and counterfeiters. (more…)

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Resellers of Illegally Imported Medications Go to Jail

JailAs I’ve written many times, though technically illegal, patients are not prosecuted for importing medication for their own use. I like how the National Academy for State Health Policy phrases it:

“The FDA chooses to exercise enforcement discretion to not prosecute individuals who fill their prescriptions ex-U.S. so long as the drugs are for personal use and the amount does not exceed a personal-use threshold of 90 days.”

But that courtesy does not (and in many cases should not) extend to people who illegally import wholesale quantities or who import for re-sale of any kind. These people get busted. That’s precisely what happened to a New Hampshire couple, John Hayes and Plabpleung Hayes, who ended up pleading guilty to illegally importing wholesale quantities of medication and reselling it in the U.S.

This illegal drug importation threatens public health and should stand in stark contrast to filling a personal prescription from a pharmacy in Canada or other countries. Ordering medication internationally can be of great help to people who can’t afford medication here in the U.S. and should not be confused with illegal drug importation for re-sale. (more…)

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What Really Happened with CanadaDrugs.com

In a plea bargain signed today with the U.S. Department of Justice, the owners of CanadaDrugs.com are forfeiting their website www.CanadaDrugs.com and other websites they operate to the U.S. government. This is an unfortunate outcome of a case that did not involve medication sales of the popular website CanadaDrugs.com, which has been safely selling medication at low cost to Americans for many years. The case involved a separate wholesale business conducted by the owners of the website. Sadly, two counterfeit batches of the cancer medication, Avastin, entered the supply chain of that wholesale business in 2011 and were sold to medical offices in the U.S. To be clear, Avastin was never sold on the CanadaDrugs.com website.

For some balance and context: in the past, CVS and CVS.com were found to be selling counterfeit Lipitor, yet this did not lead to CVS having to forfeit its website to the U.S. government.

CanadaDrugs.com had been a verified member of the PharmacyChecker Verification Program since 2005. During that time, it likely processed millions of prescriptions and filled them from licensed pharmacies in Australia, Canada, New Zealand and the United Kingdom. We have verified the licenses of these pharmacies. CanadaDrugs.com voluntarily withdrew from our program in March, aware of the pending deal with the U.S. government. The FDA recognizes that there is no urgency to shutting down CanadaDrugs.com, giving them 90 days to wind down their international retail pharmacy business. In fact, CanadaDrugs.com remains a licensed pharmacy in Manitoba, Canada.

It was necessary for the FDA to investigate and act to prevent medication from being illegally sold at a wholesale level into the U.S. The enforcement discretion used by the FDA for personal importation never extended to those who illegally import and resell medication. We at PharmacyChecker have never condoned such sales. However, the deal struck is likely to do more harm than good by shuttering a good online pharmacy that was operating safely. Making matters worse, this case has been and continues to be used by the pharmaceutical industry to fuel a campaign carried out by its front groups to scare Americans and stop them from buying lower cost, safe and effective medications from pharmacies in other countries.

Interestingly, just as the indictment in this case was slated for release in February of 2015, I sent a report to the members of congress most responsible for regulating the FDA called: “Online Pharmacies, Personal Drug Importation, and Public Health: Ill-Considered Enforcement Prevents Access to Safe and Affordable Medication.” Basically, it was my attempt to explain, with rigorous analysis and research, why shutting down the safest international online pharmacies is bad for public health. It was bad policy then and it remains so now with tens of millions of Americans not filling prescriptions each year because of cost.

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Recent Arrests in CanadaDrugs Case

On June 14 and 15, 2017, several individuals were arrested in Manitoba and British Columbia, Canada (CBC News – Manitoba) pursuant to a U.S. extradition request relating to a 2015 U.S. federal indictment of the parties on charges of illegal wholesale importation of medication into the U.S. including one batch of Avastin alleged to be counterfeit. That indictment pertains to events occurring between 2009-2011. PharmacyChecker.com strongly condemns any manufacturing and trafficking in counterfeit drugs.

Some of the individuals arrested in Manitoba, all of whom have been released on bail and are scheduled to appear in court in Canada on July 12, are also owners and/or executives of CanadaDrugs.com, Ltd. which operated a wholesale business and an online retail website. The indictment focused on the wholesale business (an area which CanadaDrugs has long since exited) and not on its website that sells medication directly to individuals for their own use pursuant to a valid prescription, does not sell Avastin, and remains licensed by the College of Pharmacists of Manitoba and an approved member of the PharmacyChecker Verification Program. We are not aware of any incident involving the sale of counterfeit medicine from CanadaDrugs.com during its 12 years operating as an approved member of our PharmacyChecker Verification Program.

We continue to closely follow this case and will post information about it, as we have done in the past.

Update: It was falsely reported on the LegitScript.com blog on July 6, 2017 that individuals connected with this case “had been extradited to the United States” (as shown below). This is incorrect and no such extraditions have occurred.  False and/or misleading reporting by LegitScript has occurred in the past in what appear to be attempts to foster negative perceptions of the practice of personal drug importation and of our own work in helping to make it safe. LegitScript is a company founded by John Horton, whom we have asked the House Committee on Oversight and Government Reform to investigate for possible government ethics violations.

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