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…)
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.
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.
As we close out 2017, personal drug importation via online pharmacies remains a viable lifeline for American patients who can’t afford prices at their local pharmacies. Recent FDA actions against pharmacy storefront offices in Florida, ones that help Americans buy more affordable meds internationally, are troubling. On a positive note, a backlash against that crackdown by members of Congress, including Senators Bill Nelson (D-FL), Chuck Grassley (R-IW), and Amy Klobuchar (D-MN) has begun and will certainly grow. But what’s most on my mind is the FDA’s vocabulary about drug importation and how people tend to confuse certain terms.
In its efforts against personal drug importation, the FDA tells the public that it’s protecting them from misbranded and unapproved drugs. Those designations sound scary and who would want such drugs? Well, Americans would. The fact is, whatever the FDA wants to call them, if medications are lawfully-produced under Good Manufacturing Practices, properly dispensed by a licensed professional and shipped by mail order, Americans are interested.
Oh, and these drugs are a hell of a lot cheaper.
Despite the clear advantages, these medications deemed to be misbranded or unapproved under U.S. law can be refused import by the FDA even if they are equally as safe and effective or the exact same as the medications sold in the U.S.