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.
(more…)Tagged with: Arthrotec, Due Process, misbranded, prescription justice
As I’ve written many times, though technically illegal, patients are not prosecuted for importing medication for their own use. I like how the National Academy for State Health Policy phrases it:
“The FDA chooses to exercise enforcement discretion to not prosecute individuals who fill their prescriptions ex-U.S. so long as the drugs are for personal use and the amount does not exceed a personal-use threshold of 90 days.”
But that courtesy does not (and in many cases should not) extend to people who illegally import wholesale quantities or who import for re-sale of any kind. These people get busted. That’s precisely what happened to a New Hampshire couple, John Hayes and Plabpleung Hayes, who ended up pleading guilty to illegally importing wholesale quantities of medication and reselling it in the U.S.
This illegal drug importation threatens public health and should stand in stark contrast to filling a personal prescription from a pharmacy in Canada or other countries. Ordering medication internationally can be of great help to people who can’t afford medication here in the U.S. and should not be confused with illegal drug importation for re-sale. (more…)
Tagged with: DEA, DOJ New Hampshire, misbranded, wholesale importation
Why does Gleostine (lomustine), above, cost 1400% more than…
Lomustine is a medication that treats cancer, which was discovered in 1976. Recently, a drug company bought the rights to market the 100 mg version of Lomustine in the U.S. and increased its price by 1400%. As a result, Americans with brain tumors are now struggling to afford this off-patent drug or simply going without it altogether. They don’t have to because Lomustine is available in Canada. There, Lomustine is marketed under the name “CeeNU” at a 97% discount.
Here are some price comparisons for CeeNU 100mg.
Until 2013, CeeNU was sold by Bristol-Myers Squibb, Co. and even available at U.S. pharmacies for about $50/pill. Now, made by a company called Corden Pharma Latina SPA, the drug is sold in the United States under the name Gleostine, which is the new – and only – FDA-approved version. Gleostine is distributed by a “start-up” drug company called Next Source Biotechnology LLC, for $768/pill. Yes, this sounds like what Martin Shkreli of Turing Pharmaceuticals did back in 2015 with Daraprim when he jacked the price from $13.50 to $750 a pill.
CeeNU 100 mg, made by Bristol Myers Squibb, can be purchased online from Canada for about $25/pill from PharmacyChecker-verified pharmacies. You can compare prices for all strengths of CeeNU. (more…)
Tagged with: cancer, ceenu, gleostine, italy, lomustine, misbranded, Next Source Biotechnology, unapproved