by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Aug 9, 2018 | FDA enforcement
The FDA has made it it’s business to shine a bright light on the evils of illegal fentanyl imports, which are sometimes sold online. That focus seems like it’s a good one. Illegal fentanyl imports get into the hands of drug dealers who use the ingredients to make counterfeit, opioid-based drugs. They sell them to addicts who too often overdose and die. I’ve written a lot about the FDA’s crackdown on illegal fentanyl imports being misused to stop imports of prescription medicines on their way to American patients from Canada and other countries. However, something much more troubling actually has gone down over the past few years.
According to documents obtained through a Freedom of Information Act request by the John’s Hopkins Bloomberg School of Public Health, the FDA ignored information about off-label prescribing of the most dangerous prescription opioid drugs: fast-acting fentanyl or transmucosal immediate release fentanyl (TIRF). Those drugs were approved to treat the most serious pain experienced by cancer patients. Instead, drug companies encouraged off-label prescribing for patients experiencing lower levels of pain and certainly did not have terminal illnesses.
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Tagged with: Enforcement, fentanyl, opioids
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Aug 1, 2018 | Drug Importation
Here’s a real story about online opioid drug dealers getting indicted and how pharma front groups conflate the opioid crisis with prescription drug importation. I write “real” to juxtapose rogue online pharmacies—that illegally sell addictive drugs—and safe international online pharmacies that don’t sell addictive drugs at all.
On July 9th, the U.S. Department of Justice for the Southern State of New York announced the indictment of Evelin Bracy and Jorge Rodriguez Lopez for illegal distribution of controlled drugs, including an analog of the opioid pharmaceutical Fentanyl – called U-47700. They are also accused of selling these drugs on the Internet from what the DOJ refers to as a website “purporting to be an online pharmacy.” The indicted parties were also alleged to have sold drugs under pharmaceutical names, oxycodone and alprazolam, that were found to have other ingredients, implying that the products were counterfeit. These counts can technically land a person in jail for 40 years.
If the allegations are true, then we’re dealing with bona fide drug pushers. The Partnership for Safe Medicines (PSM), a Pharma-funded non-profit group that seeks to conflate such drug dealing and counterfeiting with pharmacies in other countries that sell affordable prescription medicines to people here in the U.S. PSM is keeping a web diary of law enforcement busts that help stop the deadly fentanyl trade, which is taking the lives of thousands of Americans each year. We applaud law enforcement for disrupting these opioid dealing operations and bringing their orchestrators to justice.
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Tagged with: Enforcement, opioids
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jul 26, 2018 | FDA enforcement
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.
Tagged with: Bill Hepscher, Enforcement, Florida, imports
