The 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:
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.
Tagged with: fentanyl, opioids, tarbell, tramadol, warning letters
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.”
Tagged with: Bill Hepscher, Florida, imports seized, The Canadian Medstore
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.
Tagged with: canadadrugcenter, canadadrugpharmacy, canadadrugs, canadadrugstop, LegitScript, quantum solutions
[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, DOJ, montana
Last week, I published an article about new cooperation between Internet companies and the FDA undertaken to supposedly stamp out illegal opioid sales on the Internet, yet slides consciously into stopping imports of safe, lower-cost medicines. The article talked about the FDA’s Online Opioid Summit, which was held last Wednesday.
That summit was covered effectively (as much as possible) in this article from Tarbell to uncover further proof that the agency is, in fact, targeting online sales of regular, lower-cost medicines, which are imported for personal use. Reporter Michael McAuliff noted that the so-called public summit was mostly closed-door and very secretive. Reporters were not invited. Pharma, however, was well represented.
Apparently, it was the Internet companies who wanted privacy, perhaps to conceal efforts at stopping opioid sales on their platforms to not tip off the drug dealers. It could also be that they are ashamed of bowing to demands to censor content that Big Pharma/the FDA finds objectionable. Time will tell.
To his credit, Mr. McAuliff asks how big of a contributor to illegal opioid sales the Internet actually is. According to a division of the Centers for Disease Control and Prevention, only one tenth of one percent (0.1%) of illegally obtained prescription narcotics (opioids) are purchased online.
According to staff at the Internet Association, a trade group that represents about 40 large Internet firms, including Microsoft, Google, Amazon, Facebook, and Go Daddy, 3.4% of people abusing opioids obtain them from online sources. I have yet to find the survey, but will try to do so and write about it soon.
So how do we know that actions taken by the FDA to curtail illegal opioid sales online are being used against safe personal drug importation as well? The best example is the increased numbers of prescription orders being seized by the FDA using funding by Congress that was appropriated for stopping illegal opioid imports, particularly the drug Fentanyl and its analogs. As Tarbell finds, most such seizures are not opioids but regular prescription medicines.
The Tarbell article quotes FDA Commissioner Scott Gottlieb owning up to this:
“We’ll use [the increased funding from Congress] to interdict more illegal products flowing across our borders, including products ordered online, as well as shifting more of our criminal investigative resources to target these online sales. This is a conscious policy decision by the FDA, and we believe these online sales represent one of the highest areas of risk facing Americans right now.”
Tens of thousands of deaths occur each year from opioid overdose. A small fraction of those drugs were purchased online and those sales must be stopped! However, the tragedy of opioid abuse should not be used like this to stop people from getting more affordable medicines from Canada and other countries.
Tagged with: Internet association, opioids, summit, tarbell
This past month, Congress passed a flurry of bills dedicated to stopping the devastation of the opioid crisis. One focus is on stopping illegal opioid imports from coming in though the U.S. mail. The Synthetics Trafficking and Overdose Prevention Act, which passed in the House, is one such bill. But as I wrote in the The Hill last year, the STOP Act could also enable the FDA to more easily prevent Americans from importing lower-cost, safe and effective medicines from Canada and other countries.
The FDA is also fighting the opioid crisis by scrutinizing the Internet as a channel of illegal sales. That, too, could lead to the curtailment of access to lower-cost, imported medicines from pharmacies, ones which don’t sell opioids or controlled drugs at all, but do help people afford medicines.
Ideally, people who use a search engine, such as Google, find information based on an objective search algorithm. With tens of millions of Americans not filling prescriptions due to high prices here at home, many are Googling to find and order cheaper medication from international online pharmacies. (more…)
Tagged with: Eli Lilly, Google, Kaiser Family Foundation, Sheryl Sandberg, Volokh