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Due Process Exercised to Obtain Personally Imported Medicine

As announced on the Prescription Justice Blog, a person recently exercised their right to defend a prescription drug import that the FDA had detained and she won the case. The drug, Arthrotec, is available for sale at U.S. pharmacies. However, according to the patient, the drug was not affordable here in the U.S. This example shows the FDA exercising its enforcement discretion to permit medicine imports where the patient cited lower costs as the reason for the importation.

If personal drug importation is illegal under most circumstances, then what is behind this“right” to argue with the FDA?

It’s pretty straightforward:

U.S. law that affects personal prescription drug importation explicitly prevents the FDA from destroying a patient’s prescription drug import without “due process” to defend that order. That comes from Section 708of the Food and Drug Administration Safety and Innovation Act of 2012. The purpose of that law was to make it easier, ironically, for the FDA to refuse and destroy imported medicines for personal use. That can be helpful if the drugs are counterfeit or adulterated, but harmful if they are from licensed pharmacies and the patient importing them can’t afford them here—such as the case noted here.

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Want to go to jail for illegal drug importation? Here’s how…

People buying medications to fill prescriptions in Canada or other countries because prices are too high domestically don’t get prosecuted for it. But people who import drugs illegally and resell them—especially controlled drugs, like prescription opioids, benzodiazepines, and amphetamines— get busted and go to jail for a pretty long time. Even seemingly small-time drug dealers.

As reported in Madawaska, Maine’s local news WABI5, Tristan Nelson was sentenced to a year and a half behind bars for illegally importing 950 pills of Ritalin (an amphetamine) and 450 pills of Xanax (a benzodiazepine) from the Philippines with intent to sell.

Of note is that neither of the medications was a prescription opioid, which is the highest enforcement priority of the U.S. FDA. Addiction to non-opioid controlled drugs, however, is also a public health problem, and clearly law enforcement takes illegal imports of them seriously.

The short story reported in WABI5 simply noted: “Nelson admitted to investigators he ordered the pills and planned to sell them.” It did not say how he ordered them, such as from a rogue online pharmacy, but perhaps I’ll find his court documents later this month to find out more.

Rogue online pharmacies selling controlled drugs for import, and domestic drug dealing, menace the Internet. But according to government data, they are not a major factor in the nation’s crisis with drug addiction and overdose.

FDA enforcement actions leading to prosecution, fines and/or jail for illegal drug importation focus on illegal wholesale importation of all prescription drugs, whether controlled or non-controlled prescription drugs. While it prioritizes counterfeit drugs, the illegal imports can be lawfully-manufactured, safe and effective. Recently, its focus is on stopping imports of fentanyl, mostly its ingredients. Part of that battle is stopping Internet activity that leads to the illegal fentanyl trade. Such ingredients, ordered online and then imported, are used to make fake opioid prescription drugs, which have exacerbated our nation’s crisis with drug addiction and overdose.

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FDA’s Inaccurate Public Information about CanadaDrugs

The FDA’s recent press release announcing its activities in Operation Pangea XI, an enforcement operation to “crack down on websites selling illegal, potentially dangerous drugs; including opioids,” is conspicuously inaccurate about CanadaDrugs.com, which was forced to close its operations back in July. For a more general analysis of Operation Pangea XI, see my post from last week.

CanadaDrugs.com vs. CanadaDrugs

CanadaDrugs.com was the biggest Canadian online pharmacy for well over a decade. During its 17 years in business, it estimated that people ordered one billion dollars in medicines. During that time, not a single adverse reaction was ever reported by the FDA or any health agency. Their business relied on the fact that Americans are never prosecuted for personal drug importation. The law permits, and Congress has recognized the importance of, the FDA using enforcement discretion to allow personal drug imports so people can afford medicine.

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Operation Pangea XI and the Opioid SUPPORT Act vs. Safe Online Personal Drug Importation

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.

Tug of war (more…)

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FDA Warns 21 Online Pharmacies to Stop Selling Unapproved Opioids

FDA Crackdown on Illegal Online PharmacyThe FDA is warning 21 online pharmacies to stop selling certain prescription opioid drugs to people in the U.S.

According to the FDA, the 21 websites at issue are operated by four separate networks:

CoinRx,

PharmacyAffiliates.org,

PharmaMedics,

and MedInc.biz.

Each network received a similar warning letter from the FDA, which singles out their alleged illegal sales of unapproved and misbranded tramadol, also noting that a prescription was not required.

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Medicine Imports Seized by FDA in Florida

Lee Fiorentino

Click here to watch Lee tell her story

This week I’m highlighting a troubling local news story from earlier this month about the FDA seizing medicine imports from patients. Imports of medicines for personal use are under most circumstances prohibited under federal law, but millions have relied on the international pharmacy option for years. In fact, most medicines that Americans import to save money reach their destination. Recently, it seems there is a slight uptick in seizures, one that may be a casualty in the battle to stop dangerous opioid drugs. Or, like drug companies, the FDA is using the opioid crisis as a pretext to crack down on safe personal drug importation.

The report, on Spectrum News 13, comes out of Central Florida where hundreds of customers of The Canadian Medstore, a pharmacy assistance office, have said that the FDA has taken and held medicine imports shipped by mail. The FDA has received $94 million in additional funding to address the opioid crisis, including stopping illegal imports of opioid drugs, most prominently Fentanyl, which is known to be illegally imported from China. However, according to the Spectrum News report, the imports that the FDA is refusing are for regular medicines that treat maintenance conditions such as asthma, high blood pressure, and high cholesterol. The Canadian Medstore states that it does not sell prescription opioids or controlled substances of any kind.

This company was the subject of an FDA raid last fall, one that seemed overzealous if not unwarranted, which I blogged about here. It appears that as part of an investigation, imported medicines were seized and tested by the FDA at the time. According to the FDA, the medicines contained the correct active ingredients in the correct amounts.

Members of Congress Defend Safe Personal Drug Importation

Senator Bill Nelson (D-FL) has written to the FDA to express his concern about what appears to be a more aggressive stance by the agency against people buying more affordable medicine internationally. Other lawmakers who have sent other letters of concern include Representatives Kathy Castor (D-FL) and Gus Bilirakis (R-FL). Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) have also sent a letter asking the FDA if they have changed the personal drug importation policy.

Patient Asks Why?

Lee Fiorentino, 72, suffers from asthma and COPD. She was interviewed as part of the Spectrum News report because her asthma medication was detained by the FDA. The reporter did an online price search on GoodRx for Ms. Fiorentina’s medicine and the cost was $338/month in the U.S., which is over six times higher than the $52/month she pays purchasing them internationally.

Ms. Fiorentino says: “I don’t understand why [the FDA] would want my asthma medication. It just seems like a strange thing to do.”

Indeed.

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