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Helping Americans Get The Truth About Prescription Drug Savings
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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:

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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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NABP Changing Its Tune on Drug Importation?

For years, the National Association of Boards of Pharmacy (NABP) has opposed new drug importation proposals that would improve access to more affordable medication from Canada and other countries. Led by its executive director, Carmen Catizone, PharmD, the NABP’s efforts pertaining to drug importation have focused mostly on opposing online access to imported medications – meaning Americans getting cheaper meds from Canada and other countries. This is not surprising. NABP has received a lot of money from pharmaceutical companies for these efforts. Also, NABP represents U.S. pharmacy boards and the members of those boards often have financial interests in U.S. pharmacies. But here’s a surprise…

Earlier this week, an article in the Washington Post focused on various prescription drug importation programs offered by cities, counties and schools to lower pharmaceutical bills for retirees and municipalities. According to the article, the FDA may view these programs as illegal. The FDA recently raided some pharmacy storefronts in Florida but did not shut them down. Those programs help Americans—especially the elderly— order affordable medications from other countries. Operating for 10, some even 15 years without interruption, they continue to save millions of dollars a year.

Mr. Catizone had the last word in the article. (more…)

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Eli Lilly’s and Alex Azar’s Position on Importation is a Canard

Alex AzarThis week, President Trump potentially handed Big Pharma one of its greatest victories by appointing Alex Azar the new Secretary of Health and Human Services (HHS). Why? Until earlier this year, Alex Azar was the president of Eli Lilly USA and few people (companies are people?) on earth personify Big Pharma like Eli Lilly.

This matters to Americans who import lower cost medication to fill prescriptions because the FDA is an agency housed in HHS, and HHS has a lot of statutory power when it comes to importation of prescription drugs.

President Trump campaigned on making it legal for Americans to buy lower-cost medications from other countries, but Eli Lilly and Alex Azar are leading opponents of safe importation. In fact, Eli Lilly is perhaps the leader when it comes to hatching, or funding, strategic communications and lobbying campaigns to stop Americans from using safe, international online pharmacies. Its efforts through the non-profit group, Alliance for Safe Online Pharmacies—FUNDED BY ELI LILLY—have been frighteningly successful at fooling our elected officials and the public that international online pharmacies are inherently bad for Americans. They do so by conflating counterfeit drugs and even fentanyl abuse with safe international online pharmacies. As I see it, Eli Lilly’s narrative on online pharmacy and importation incorporates the most sinister aspects of fake news. Really. (more…)

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FDA Relinquishes Control to Foreign Drug Regulators

FDA Commissioner, Scott GottliebThis week, FDA Commissioner Scott Gottlieb announced that inspections by drug regulatory authorities of foreign manufacturing plants that export pharmaceuticals to the U.S. are sufficient to ensure the integrity of those products: meaning the FDA doesn’t also need to inspect them. The countries identified are Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom. All are currently members of the European Union (the UK is soon Brexiting).

Although this has made headlines as an unprecedented practice, the FDA relying on inspections from foreign regulators is not an entirely new development. The FDA does not inspect all foreign plants that export medicine to the U.S. even though most pharmaceuticals sold in the U.S. are foreign-made.

So what’s with the big announcement then?

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Why Pharma Is So Focused on Importation

Last weekend, Jay Hancock of Kaiser Health News wrote an article entitled “Everyone Says We Must Control Exorbitant Drug Prices. So, Why Don’t We?” I’ve been thinking about it all week, as it ubiquitously made the rounds among our community of activists, journalists, policy wonks, etc.—many passionate people that focus on drug pricing and viable solutions.

Mr. Hancock’s answer was most cogently provided by writing that momentum has slowed on drug prices: “amid rancorous debates over replacing Obamacare (…) stalled by roadblocks erected via lobbying and industry cash.” Yesterday, with the threat of Obamacare’s demise alleviated, it’s worth noting, Congressman Elijah Cummings (D-DE) called out President Trump’s inaction on drug prices and for flouting his campaign promises. I suspect there will be more hearings, and talk, and talk, and condemnation, more talk, and exasperation with Big Pharma, mostly from Democrats but also from Republicans.

While pharmaceutical company lobbying initiatives loom over Congress’ every move preventing legislation and regulatory reforms to actually help Americans, patients are forced to ration and tens of millions skip taking critical meds due to cost. Mr. Hancock gives a rundown of the policies on the table to tackle high drug prices: drug importation, transparency, Medicare drug price negotiations, improved generic availability and competition. (more…)

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