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A Letter from 33 Members of Congress to Obama Commends Expressly Permitting-Legalizing Importation

We The PeopleEarlier this month 33 members of Congress sent a letter to President Obama asking him to use executive authority to tackle the crisis of high drug prices in the U.S. The gist of the letter is that Congress is paralyzed (surprise surprise) to act. So, while we wait, and wait, and wait for Congress — the urgency of high drug prices calls for executive action.

One of the steps recommended is to expressly permit Americans to import lower cost medications for personal use. Well, Americans already do that and while its technically illegal, people aren’t prosecuted for doing so, and thus it’s generally permitted. But if it was expressly permitted it would remove the stigma of illegality, embolden many more consumers to import lower cost medication, deflate and defang the scare tactics of the pharmaceutical industry about importation and online pharmacies, and would instill more price competition into the U.S. market to bring down prices at local pharmacies.

A few questions. Don’t we need to pass a new law to “legalize” importation? Why do I choose to bold the phrase expressly permit? Would it be legal or expressly permitted? Maybe both? (more…)

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What do Donald Trump, Hillary Clinton, and Bernie Sanders have in common? Support for Drug Importation.

Donald Trump, Hilary Clinton and Bernie Sanders

Yesterday, our CEO, Tod Cooperman, MD, applauded leading presidential candidates for supporting legal reforms to make it easier for Americans to buy lower cost medications from other countries.

“With millions of Americans doing this safely for more than a dozen years, it’s time for our government to stop threatening and scaring consumers and simply do what’s right: Make personal drug importation fully legal. Every presidential candidate should support this,” says Dr. Cooperman.

To read the full press release, go here: http://www.pharmacychecker.com/news/trump-clinton-sanders-support-drug-importation.asp.

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John and Laura Arnold Foundation Helping To Tackle High Drug Prices…But What about Personal Drug Importation?

With its gift of $7.2 million to fund various research projects, the John and Laura Arnold Foundation gave a boost this week to the cause of lowering drug prices in America. According to the Foundation’s press release: “The research projects will focus on analyzing how regulatory policies and programs impact drug pricing, drug development, and patients’ access to medication.”

The lion’s share of the funds will go to the Memorial Sloane Kettering Cancer Center’s Evidence Driven Drug Pricing Project. Led by Dr. Peter Bach, the effort pursues strategies to evaluate the relative effectiveness of medications. The goal of Dr. Bach’s project is to make sure that medications are priced according to how well they actually work. Sounds like common sense, but too often medications that often don’t work are widely prescribed, and very expensive!

The money will also go toward various evidence-based studies looking into the workings of the drug development pipeline, state and federal regulations that affect Medicaid drug purchasing, and alternative Medicaid purchasing models that tie reimbursement to patient health outcomes.

One smaller project caught my eye, because it looks at pharmaceutical regulations and law that affect innovation. The Brigham and Woman’s Hospital’s Program on Regulations, Therapeutics, and Law will receive $748,445 to analyze existing regulations enacted to incentivize pharmaceutical innovation. The press release reads: “Researchers will analyze programs and incentives such as tax breaks, market exclusivity protections, and the Food and Drug Administration’s (FDA) fast-track approval pathways.”

In looking at regulations and law, the cause of lower drug prices would be well served by a research project dedicated to evaluating the effects of federal restrictions on prescription drug importation. Ostensibly, drug importation restrictions are in place to prevent unsafe and counterfeit medications from reaching patients, but we know that they also curtail access to lower cost, safe and effective medication as well. That’s why millions of Americans buy foreign medication online despite the prohibiting regulations.

New research would help determine a more suitable regulatory framework to protect patient health, but also expand access to more affordable medication through safe personal drug importation. This recent grant by the John and Laura Arnold Foundation is its second in the area of prescription drug prices. Three’s a charm!

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Fewer Americans Importing Medications in 2016: Good or Bad? Oh, and Happy New Year!

Times Squaer Crowd New Year's Eve
As we move out of 2015 and into 2016 with a strong wave of hostility rising throughout the country about high drug prices, what I’m about to report may seem incongruous. Fewer Americans seem to be buying lower cost medications from other countries. For the past few years, largely based on data from the CDC in 2013, I’ve published the number five million as the approximate number of Americans who, due to high drug prices, import medication annually for personal use. But a newer CDC report published in 2015 (that I recently came across) puts that number closer to four million, a 20% decrease.

If drug prices are going up, and Americans are fed up with prescription costs, wouldn’t you expect more people to be buying lower cost medications from outside the country? With fewer Americans buying medication internationally, potentially one million, how many of them are simply not taking prescribed medication? Are our most trusted authorities scaring Americans away from obtaining lower cost medications from other countries, or has affordable access improved over the past few years?

(more…)

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A New Non-Profit Is Born – Prescription Justice Action Group – To Help Americans If Their Meds Are Taken by the FDA

pjag_banner_med

Today, as the Obama administration hosted a “public” forum (think invitation only) about pharmaceutical innovation, access and affordability, I announced the formation of a non-profit organization dedicated to helping Americans get justice when it comes to prescription drug prices: Prescription Justice Action Group (PJAG). Whereas the administration’s public forum ignored personal drug importation, PJAG is providing guidance to Americans on what to do if their prescription drug orders are refused import by the FDA so they can try to have their medications released.

For about fifteen years, tens of millions of Americans have purchased medication from outside the U.S. –usually ordering it online. They do it because they want to save money or they really cannot afford the medication here at local pharmacies. The fact is that it has become a lifeline of lower cost medications for Americans.

But a new law – Section 708 of the Food and Drug Administration Safety and Innovation Act – gives the FDA expanded powers to destroy your personally imported medications, whether bought from a Canadian, Indian, Turkish or U.K. pharmacy. That doesn’t mean they will. It just means that they can. That law became effective over a month ago, and we haven’t heard of increased FDA seizures and destructions of international prescription orders.

The FDA has stated, and we have re-affirmed on our blog and main website, that under most circumstances it’s technically illegal to import prescription medication for personal use. But is it really? Is it always?

Section 708 allows the FDA to detain and potentially destroy your prescription order if it appears to be misbranded, unapproved, counterfeit or adulterated. If they take your adulterated or counterfeit drugs then the FDA has done their job. Misbranded or unapproved drugs, in contrast, could be entirely safe and effective medications, the same or foreign versions of the ones you buy in the U.S., but much less expensive. Under Section 708, you must be notified by the FDA if they take your prescription drug import, and you have 20 days to challenge them on their action. PJAG, in consultation with legal advisers, believes that you can make a good case that FDA should not destroy the medication but instead send it to you.

There are many dangerous online pharmacies out there from which you don’t want to buy or import medication. We call them rogue online pharmacies. But if you import a genuine, safe and effective medication, one that was purchased from a PharmacyChecker.com-approved online pharmacy and you get a notification from the FDA telling you that your prescription drug order is subject to destruction…PJAG!

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On The Newly Formed Congressional Task Force on Prescription Drug Prices…

Affordable Drug Pricing Task Force Press Conference November 4, 2015
Americans should know about the heat coming down against the pharmaceutical industry from certain members of Congress in an effort to combat the public health crisis of high drug prices. This week, nine lawmakers from the House of Representatives announced the formation of a new group called the Affordable Drug Pricing Task Force. Its goals are clear, to lower cost barriers to life saving medication and to demand greater transparency about drug cost decisions made by the pharmaceutical industry.

Two pertinent facts were continually raised. One, high drug prices are the No. 1 healthcare issue in America. Two, medication prices are much lower in other countries, about 50% lower in the UK.

To announce the task force, a press conference was led by Congressman Lloyd Doggett (D-TX) and included speeches by Rep. Sander Levin (D-MI), Rep. Jan Schakowsky (D-MI), Rep. Jim McDermott (D-WA), Rep. Rosa DeLauro (D-CT), Rep. Peter Welch (D-VT), Rep. Marcy Kaptur (D-OH), Rep. David Cicilline (D-RI), and Congressman Elijah Cummings (D-MD). We wrote about Rep. Cummings’ efforts a couple of weeks back as Congressman Cummings noted PharmacyChecker.com as a supporter of the Prescription Drug Affordability Act of 2015. I also want to note  thank Congresswoman DeLauro for recently becoming a co-sponsor of the Personal Drug Importation Fairness Act of 2015.

The speakers have supported a variety of solutions to lowering drug prices, including allowing Medicare to negotiate drug prices with pharmaceutical companies; ending “pay-for-delay,” a practice sometimes described as payoffs by brand drug patent holders to generic drug companies to that the latter will postpone launching a lower cost generic; reforming prescription drug importation laws to make it easier to access lower cost medications from other countries; and greater oversight into pharmaceutical industry pricing practices.

Some highlighted quotes or phrases:

  • “If the people are not able to afford their prescriptions that means they suffer and in some instances they die.” Rep. Cummings.
  • McDermott’s take: “The pharmaceutical companies have got the Congress in the palm of their hand and they will not let us go.”
  • The problem of high drug prices was referred to as an “emergency situation” by Rep. Sander Levin.

It’s no secret that I support much of this agenda. But what is needed is bipartisanship, and I’m waiting for these leaders, as part of their noble effort, to consider looking critically at the Obama administration’s record on personal drug importation and online pharmacies. Candidate Obama in 2007 supported reforming the law to make it easier for Americans to import lower cost medication. Unfortunately, in its efforts to pass the Affordable Care Act, which I supported, the Obama administration made a deal with big pharma to change course and dump drug importation legal reform in exchange for pharma’s support for Obamacare and agreement to new discounts on Medicare Part D medications through the coverage gap (the “Donut hole”).

On that final note, the Obama administration, though the Department of Health and Human Services (HHS), has announced a forum on drug prices to be held on November 20th. Maybe we’ll learn that the Obama administration’s position on prescription drug importation has returned to one more in line with most Americans. We’ll keep our fingers crossed.

(You can view the complete press conference below)

Affordable Drug Pricing Task Force Press Conference

Members of the newly formed Affordable Drug Pricing Task Force will hold a press conference announcing meaningful action to combat the skyrocketing costs of pharmaceuticals. Who: Reps. Cummings, Doggett, McDermott, DeLauro, Schakowsky, and Welch.


Affordable Drug Pricing Task Force Press Conference – Nov 4, 2015

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