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HHS and FDA Drug Importation Idea: Important Takeaways

Alex Azar, Eli Lilly

Azar is proposing a discussion about allowing imports of single-source drugs to lower costs

Yesterday, Health and Human Services Secretary Alex Azar announced that he was tasking FDA Commissioner Scott Gottlieb with forming a working group to explore how drug importation could be used to lower prices. See Gottlieb’s remarks on the proposal.

The crux of the proposal is very narrow. Azar is considering allowing imports of foreign versions of off-patent medicines that only one manufacturer (also referred to as “single-source” drugs) is selling in the U.S. market. That would be a drug without any competition where the company with the marketing license jacks the price. Keep in mind that he has simply called for a working group to discuss it.

I’m getting asked a lot of questions about this proposal and realize that many people, including well-informed journalists and policy professionals, don’t really get this.

People who already import medicines, through buying them online or carrying them home from Canada to save money may also be confused!

So, to help any and all understand what HHS and the FDA are considering when it comes to drug importation, below are some important takeaways. My general take, as noted in the Washington Post, is that it’s a step in the right direction (if it goes forward), and it could help educate the public about greater potential benefits to larger scale importation.

  • This is not legalizing buying cheaper, FDA-approved meds from retail pharmacies in Canada online or otherwise.
  • Millions of Americans already benefit from importing lower-cost, safe and effective medicines for personal use. They do this despite the existing federal prohibitions and scare tactics employed by industry-funded groups to deter such purchases. To do so safely, they stick to credentialed online pharmacies, such as those verified by PharmacyChecker.com. Today, Roger Bate, who is affiliated with the American Enterprise Institute, wrote: “All the FDA has to do is allow Pharmacy Checker to do its job and tell the American people about it.”

(more…)

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A Drug Importation Vocabulary Lesson: Misbranded and Unapproved Drugs

Words matter when it comes to drug importation

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.

Here’s why… (more…)

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Do Board Members of PhRMA Support Importing Unapproved Medication?

Since Americans started importing medications for personal use in larger numbers at the beginning of the last decade, the Pharmaceutical Researchers and Manufacturers of America (PhRMA), Big Pharma, has engaged in media and government relations scare tactics to try and stop them.  Apparently, when it comes to foreign versions of the new FDA-Approved Emflaza, which treats Duchenne Muscular Dystrophy, one board member of PhRMA supports importation!

Last week, I wrote about the decision of drug company Marathon Pharmaceuticals to postpone selling Emflaza over pricing concerns and how the issue shines a bright light on the benefits of personal drug importation. To summarize: some folks are outraged because Emflaza (deflazacort) was launched at a price of $89,000 for a one year supply. This seems insane when foreign versions of deflazacort, which cost 1% that amount (less than $1000), are already imported for personal use.

PhRMA is trying to distance itself from Marathon, just like it did with Martin Shkreli, former CEO of Turning Pharmaceuticals, when the price of Daraprim jumped from $13.50 to $750 a pill overnight. The CEO of Marathon, Jeff Aronin, however, sits on PhRMA’s Board of Directors! Last week, John Carroll of Endpoints News predicted last week that Aronin might be dropped. As of today, he’s still there.

Mr. Aronin wrote a letter to the Duchenne community that fully acknowledged American kids were already being treated with an unapproved foreign version of deflazacort. In his words: “As we all know, deflazacort was being used without FDA approval — and without ever having been approved anywhere in the world for Duchenne — by a very small group of patients (roughly 7 to 9 percent) in the Duchenne community who imported it from overseas.”

But does he support it? I mean, after all, the “score” for Marathon is that once it’s available for sale in the U.S., it will be purchased here. At least for the time being, this PhRMA board member does support it and seems to have no concern whatsoever whether the foreign version is safe and effective, not should he, since, like other medications, it was approved for safety and efficacy elsewhere. In noting that Marathon will “pause our commercialization” of Emflaza,” maintain its Expanded Access Patient Assistance Program, Aronin also state: “Patients currently receiving deflazacort from other sources may continue to have that option.” Damn right.

Is it hypocritical of PhRMA to diss Marathon? After all, brand drug companies jacked prices 130 times the inflation rate in 2015. Forty-five million Americans didn’t fill a prescription in 2016 due to cost. PhRMA will continue its practice of legal bribery and unleash a new, shiny PR campaign about life sciences and innovation — to prevent legislative and regulatory reforms that would lower drug prices. It’s going to take an unpredictable, unexpected populist wave of American anger at drug companies to bring their house down. In the meantime, maybe the people will take a hint from one PhRMA board member and import unapproved and lower cost medications.

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