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.
FDA Targets Safe International Online Pharmacies
In an ideal world, where protecting the public health is the only goal of the FDA, safe international online pharmacies, ones that facilitate personal prescription drug import orders from licensed pharmacies, would not be implicated by the FDA or the SUPPORT Act. Unfortunately, the FDA is willing to target safe international online pharmacies and other forms of safe personal drug importation.
However, in most instances, the companies and people who operate those targeted safe online pharmacies were also engaged in some form of wholesale importation. Such was the case with CanadaDrugs and CanadaDrugCenter. In the case of CanadaDrugs.com, certain companies operated by its owners were exporting oncological and other medicines to wholesalers in the U.S. who then distributed the products to medical clinics. Under U.S. law, the drugs were generally deemed to be misbranded even if manufactured lawfully. A batch of counterfeit Avastin was discovered in 2011 by authorities in Europe, leading to a vigorous investigation and prosecution instigated by the FDA Office of Criminal Enforcement against the owners of CanadaDrugs.com. In the case of CanadaDrugCenter, its owners pled guilty to selling misbranded medicines to U.S. pharmacies who imported them for re-sale. Neither of those companies were alleged by the FDA to have ever sold counterfeit or substandard medicines online as part of their retail operations. Both companies had to forfeit their websites as part of their plea agreements. Oddly, the FDA claims that the www.CanadaDrugs.com was seized not forfeited.
Pangea XI Targets Rogue Online Pharmacies
As part of Pangea XI, the FDA seems to be keeping its enforcement actions in line with targeting rogue online pharmacies, which is great. The FDA issued warning letters to websites marketing and selling opioid drugs into the U.S. without a valid prescription. It also issued warning letters to online pharmacies selling non-controlled prescription medicines, without requiring a prescription. As far as I’m aware, no safe international online pharmacies, meaning ones that are verified by PharmacyChecker or other organizations that have similar standards to our verification program, were targeted.
There was some vague language about the FDA Office of Criminal Investigations continuing “an effort that started back in 2012. As part of Operation Pangea V conducted in 2012, the FDA sent warning letters to the Canada Drugs Online Pharmacy Network.” It seemed to serve as a reminder for international online pharmacies not to consider wholesale importation in any manner. If that’s the case, then I agree with the FDA’s warning.
SUPPORT Act – A Double-edged Sword for Personal Importation
The SUPPORT Act includes language that protects people who import medicine for personal use from debarment. A person who is debarred can no longer work in an FDA-regulated industry. The protection built into the SUPPORT Act makes it clear that personal importers and those who offer imports for sale for personal use are not the target of debarment. And, as I’ve argued recently on these pages, the law, while ambiguous, has a lot to say about protecting personal imports to help Americans afford medicines.
Still, it’s a double-edged sword: SUPPORT also makes it easier to stop personal imports, whether counterfeit opioids or lower-cost blood pressure medicine at international mail facilities. It provides new channels of cooperation between the FDA and U.S. Customs and Border Protection. It also requires new rules for the U.S. Postal Service that can stop personal imports by incorporating the provisions of the Synthetics Trafficking and Overdose Prevention Act (STOP).
See the pro-industry media outlet, Securing Industry, to explain these powers in SUPPORT: FDA gains new powers to block illicit drug imports
See my op-ed about the STOP Act: A tale of two drug bills — one proposed bill will worsen the drug prices crisis
The bottom line is that the FDA is now more legislatively and resource empowered to stop safe personal drug imports, even if federal law indicates that the FDA should only focus on stopping dangerous drug importation. An amazing irony.
So Where Does This Go?
There are many examples of safe personal drug importation and using it wisely as a channel of affordable medicine in America. Economist and medicine quality expert Roger Bate reminds policy-makers in AEI’s blog that medicines ordered from properly-verified international online pharmacies have a great track record of safety:
“All the FDA has to do is allow PharmacyChecker to do its job and tell the American people about it.”
Hundreds of thousands of Americans participate in local government and other programs offered by self-insured cities, counties, towns and schools that reduce their drug costs through personal importation. Just this week, it was reported that a health insurance company in Utah announced a program that incentivizes its members to go to Mexico and obtain certain very expensive medicines at a much lower cost than they could find domestically.
But, in fact, there are people going online everyday and ordering products from rogue sites shipped from foreign pharmacies from who knows where. Many of those orders are dangerous.
So, how will the FDA use its new authorities? The law says it can use them to help people obtain lower-cost medicines from other countries, or at least not prevent them from doing so.Tagged with: Enforcement, Interpol, Operation Pangea, opioid