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.
Tagged with: Enforcement, Interpol, Operation Pangea, opioid
“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 PharmacyChecker.com. 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.
Tagged with: Interpol, pangea
The Obama administration is taking actions to address the illegal sale of counterfeit prescription drugs online. These efforts can benefit patients who could fall victim to rogue online pharmacies, but may also limit access to safe and affordable medication provided by non-U.S. international online pharmacies, many based in Canada. Millions of uninsured and under-insured Americans have purchased prescription drugs through, and relied on, such websites to afford medicine.
Last Monday, the White House Intellectual Property Enforcement Coordinator (IPEC), Victoria Espinel, stated that her office was in discussions with Google, Go Daddy, American Express, and Microsoft about cracking down on online pharmacies, and that an announcement about IPEC’s plans moving forward will be made within weeks. This statement seems to be a follow-up to a late-September meeting held by IPEC, which brought together domain registrars and registries to discuss voluntary protocols to combat the sale of non-controlled counterfeit medication online. As we reported, the Internet Corporation for Assigned Names and Numbers (ICANN) notably declined its invitation to attend this meeting, and at least one of its attendees, Go Daddy general counsel Christine Jones, as reported on Domain Incite, communicated that intellectual property protection was not discussed and voluntary protocols were not agreed to. Jones also shared her understanding that an “FDA solution” might be used to combat counterfeit drugs being sold online. Espinel’s statement last week suggests the same. (more…)
Tagged with: Alliance for Safe Online Pharmacies, American Express, drugs from canada, FDA, GoDaddy, Google, I-Save RX, ICANN, intellectual property rights, Interpol, IPEC, Joseph Biden, Katheleen Sebelius, Margaret Hamburg, Microsoft, Obama Administration, Online Pharmacies, Pfizer, public health, Public Library of Science One, Rahm Immanuel, rogue pharmacies, under-insured, uninsured, United States