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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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Cancer Drug Lomustine Sold in Canada for 97% Cheaper

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…)

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