by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jul 19, 2018 | FDA enforcement
The online pharmacy, CanadaDrugCenter.com, which had been verified by PharmacyChecker, is no longer accessible over the Internet. At the end of June, the managers of the online pharmacy—and others owned by them, CanadaDrugPharmacy.com and CanadaDrugStop.com—informed PharmacyChecker that they were withdrawing from the PharmacyChecker Verification Program because they were going offline, but they did not tell us why.
We still don’t know why, either, but I suspect it has to do with the U.S. government’s case against its owners dating back to 2007-2011.
(more…)
Tagged with: canadadrugcenter, canadadrugs, Enforcement
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jul 17, 2018 | Online Pharmacies
From time to time, we participate in the public policy process by submitting public comments to government agencies requesting them. In May of this year, after introducing the Trump administration’s blue print plan for lowering drug prices, the Department of Health and Human Services (HHS) asked the public to comment on the Trump administration plan and/or make recommendations for lowering drug prices and out-of-pocket prescription costs.
I submitted comments that were laser-focused on PharmacyChecker’s area of greatest expertise, personal drug importation and online pharmacies. My comments clarify why and how properly-verified, international online pharmacies are a lifeline of safe and affordable medicines for Americans.
PharmacyChecker Public Comments to HHS July 13, 2018
The basic recommendations offered in the comments are below:
- Under Section 804 (j) of the Food, Drug and Cosmetic Act, the Secretary of Health and Human Services should expressly permit medicine imports for personal use to empower patients seeking affordable medication.
- Per the above, implement the Australian model of making personal drug importation legal with caveats to prohibit personal use imports of controlled drugs, especially prescription narcotics.
- The FDA should end its blanket warning against ordering medicines online, imported for personal use from pharmacies in Canada and other countries, and instead provide guidance on best practices for those who choose to import.
- The FDA should stop seizing personal imports of non-controlled medicines arriving from pharmacies that the FDA knows are licensed and require valid prescriptions.
- The FDA should take no enforcement actions against international online pharmacies that it has reason to believe are the safest international options available to Americans and instead focus on those that represent the gravest threats, particularly ones that sell prescription narcotics.
Tagged with: imports, politics, public comments
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jul 13, 2018 | FDA enforcement
[UPDATE: Today (July 13th, 2018), CandaDrugs.com, and other sites it owns, such as JanDrugs.com, have stopped selling medicines to patients in the U.S. in accordance with an agreement with the U.S. Attorney in Montana. Below, please read to understand why this happened. Several stories in the media are reporting that the reason is that patients bought counterfeit drugs from the online pharmacy, which is not true.
Bottom line, as I see it: a very well-run, safe, international online pharmacy was forced by the U.S. government to stop helping Americans afford prescription drugs because the pharmaceutical industry wanted that outcome.
It’s a shame and American patients struggling with prescription costs are worse off for it.]
[FIRST PUBLISHED APRIL 13, 2018]
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.
Tagged with: avastin, canadadrugs, Enforcement
