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Unapproved but safe and effective…

Personal drug importation works! This week, drug company Marathon announced  it is postponing the launch of Emflaza, its recently FDA-approved version of an off-patent drug called deflazacort, in the face of heavy scrutiny by Senator Bernie Sanders and Congressman Elijah Cummings over its price tag – $89,000 a year. This drug, which treats Duchenne Muscular Dystrophy (DMD), is available under the brand name Calcort in the United Kingdom at about 99% less (about $750) than the current U.S. “postponed” price. Generic versions of deflazacort are also available internationally among verified online pharmacies at an annual price tag of about $650.

For some background on the disease and treatment: DMD is a “genetic disorder characterized by progressive muscle degeneration and weakness.” It mostly afflicts boys, with onset ranging from ages 3-5. It’s caused by the absence of a protein called dystrophin. For more, see the Muscular Dystrophy Association’s (MDA) website. According to the MDA, corticosteroids, including deflazacort, help slow the disease’s progression.

For a critique of the Emflaza price read Sanders and Cummings’ letter. No one could do better than that. Marathon CEO Jeff Aronin attempts to rationalize the price here but it almost reads like an apology. They argue that no consumer will deal with the $89,000 price tag because health insurers only charge a $20 co-pay and they have patient assistance programs to help the uninsured. It’s never that perfect, at all: people always slip through the cracks and we’re not forcing people to go without needed medication or go into bankruptcy to get it. Right?

So now a fist full of truth about this medication and safe online access to affordable medicines to shine a bright light on the lifeline that is personal drug importation…

Marathon, in a letter to the Duchenne community explaining its decision to postpone launching the Emflaza, states that 7-9% of patients in America already import the drug for personal use. That importation is in line with FDA’s policy, developed so that medications not available domestically could be imported for personal use.

Bizarrely, the drug company is communicating its concern that patients won’t have access IF they launch the drug! How can it be that not launching the drug in the U.S. market will protect access for Americans? There’s a twilight zone explanation. Technically IF it’s available for sale in the U.S., including for a price of $89,000 a year, the personal exemption for importation may no longer be expressly permitted – meaning access denied.

Still confused? MDA gives a long and forgiving (to the drug company), but very enlightening description of what FDA’s approval of Emflaza means for patients (and it ain’t simple or pretty) but I’m going to quote its full answer about importation of deflazacort and then try and explain it:

“Now that Emflaza is approved, will patients still be able to get deflazacort from abroad? If so, for how long?

Marathon has no control over deflazacort availability from overseas pharmacies, and will be focused on making Emflaza available to patients in the U.S. Marathon is working very closely with healthcare providers and Masters, a UK-based pharmacy that has been a large supplier of deflazacort, to help ensure a smooth transition. To that end, Marathon has developed robust patient support services including patient assistance programs and will be using a specialty pharmacy to provide prescription fulfillment and support.”

Wow! This verbiage affirms a few important facts about drug importation and online pharmacies: 1) Americans can and do get very affordable deflazacort from the UK; 2) According to MDA, they may not be able to any longer. Why? Because there’s a more expensive version available in the U.S.! 3) Marathon is working with an online pharmacy in the UK (which PharmacyChecker has not verified but presumably MDA has), one that ships a version of deflazacort that the FDA would consider unapproved – but is permitted for sale in the UK!

For years, parents of kids with MDM have been importing what is, according to the FDA, an unapproved drug, but is nonetheless safe and effective, at a price they can afford, which has helped their kids live better lives. Why stop them now? Because there’s a more expensive version here?

This story aptly explains why tens of millions of Americans have used personal drug importation, often placing orders online, despite federal restrictions. It enables them to obtain FDA-approved and foreign versions of FDA-approved safe and effective medications, which they can’t afford here. With forty-five million Americans not filling prescriptions each year because of cost, I have no doubt they will need to continue doing so.



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