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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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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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Sen. Nelson Wants Answers from FDA on Actions Against Affordable Rx Imports in Florida

Sen. Nelson.

Standing up for his constituents on drug prices

Last month, I blogged about the FDA Office of Criminal Investigations’ sending agents with search warrants to pharmacy storefronts in Florida that help older people buy more affordable medications from Canada and other countries. The FDA tried unsuccessfully to get one of the stores’ owners, Bill Hepscher, who runs Canadian MedStore, to sign a statement acknowledging that reimportation of prescription drugs is illegal. The Florida pharmacy storefront story was first reported in Kaiser Health News.

Yesterday, Senator Bill Nelson (D-FL) sent a letter to FDA Commissioner Scott Gottlieb demanding to know why some prescription orders coming from Canada and other countries were seized, and inquiring why the FDA raided the storefront offices.

Clearly, Sen. Nelson understands the technical illegality of personal drug imports and the need to protect people from counterfeit drugs and Fentanyl. However, his letter underscores his confusion about why the FDA is stopping people from getting non-controlled, regular prescription drugs now. He wants to know specifically if there is a change in FDA’s overall enforcement policy.

I’ve been warning about the serious public health ramifications of overzealous FDA enforcement on access to affordable medication for a long time. In 2015, I wrote a report about online pharmacies and personal drug importation, and sent it to the Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce.

Back in 2006, Senator Nelson played the leading role in ending stepped-up enforcement efforts by U.S. Customs and Border Patrol (more…)

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