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New FDA Tests Indicate Imported Drugs Are Safe

 

FDA Testing Lower-Cost Imported Medications

Tens of millions of people have bought medications from foreign pharmacies – despite the technical illegality of importing those medications. According to reporting by Kaiser Health News last month, the FDA tested imported medications, apparently to see if what Americans are doing is safe. All medications the FDA tested “contain[ed] the ingredients matching the medicines ordered.”

The Kaiser Health News reporting was focused on international pharmacy options offered by local governments and school. While that’s interesting, it’s not breaking news (I mentioned it here). The FDA testing imports and saying the medications are safe, albeit begrudgingly, is breaking news. (more…)

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“Bring me back some Canadian insulin. It’s 50 percent cheaper up there.” – Shameless Shames Big Pharma

Shameless Showtime TV seriesThe December 17th episode of the television comedy Shameless provides a pathetic commentary on unfairly high prices of drugs in the U.S.  In the episode, the lead character, Frank, announces that, for a fee, he’ll help smuggle Americans into Canada. But, it turns out, what people really want is for Frank to buy and bring back their much-needed medicines–medications such as EpiPens, insulin, Invokana, and Tecfidera from Canada where they are more affordable.

Here’s the dialogue:

(more…)

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Alex Azar is the Wrong Pick to Lead HHS

Last month, I published an op-ed in The Guardian in opposition to Alex Azar for Secretary of Health and Human Services. In advance of the Senate Finance Committee Hearing tomorrow over his nomination, I’m publishing my article in its entirety below. 

Recently, the president announced Alex Azar as his nominee to lead the US Department of Health and Human Services, saying: “He will be a star for better healthcare and lower drug prices!” People like me – experts in drug policy and advocates for lowering drug costs for American patients – know that nothing could be farther from the truth.

On average, Americans pay twice as much for life-saving drugs as consumers in other developed countries. It doesn’t have to be this way, but unfortunately, Azar might think so.

On Wednesday, Azar appeared before the Senate Health, Education, Labor and Pensions committee. While he stated his commitment to lowering drug prices, he declined to support the two solutions that would have the greatest impact on patients. In fact, he and his company have vigorously opposed policies that would make healthcare more affordable for the rest of us. (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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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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