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Omnibus Bill Empowers FDA to Confiscate Imported Drugs

The recently signed appropriations or “omnibus” bill to fund the federal government includes an additional $94 million (Section 778) for the FDA to screen and stop drug imports at international mail facilities (IMFs). That could mean fewer people receiving their prescription medications that they have ordered from Canadian or other international pharmacies.

As I wrote a couple of weeks ago, the FDA’s coming crackdown against opioids could be a cover for greater import refusals and destruction of imported medications. This new appropriation of $94 million is a lot of money. In the case of drug importation, that money could be used for good (intercepting opioid ingredients en route to drug dealers or addicts) or evil (refusing and destroying prescribed medication en route to a patient who can’t afford the drug here).

You can read the section of the bill showing the appropriation and what it’s for at the end of this post. It states that the money is for “necessary expenses of processing opioid and other articles imported or offered for import through international mail facilities of the U.S. Postal Service.” Those “other articles” include prescription medications from pharmacies in Canada and other countries. Since the FDA considers those imports illegal, at least under most circumstances, it can refuse them and even destroy them – but must first alert the patient who ordered them giving them due process to defend their prescription order. (more…)

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Bloomberg Editors Call U.S. Drug Prices A Crime

The heat is rising on the pharmaceutical industry because of high drug prices. The politically and economically middle-of-the-road editors at Bloomberg published an opinion piece this week called “U.S Prescription Drug Costs Are a Crime.” The gist in the article is that policy tweaks are not enough, pointing out that President Trump’s rhetoric on drug prices is much stronger that the reality of his actions. Major changes are needed, such as drug price negotiations in Medicare and making importation of lower-cost medication legal (something one in ten Americans already do, according to Bloomberg).

I love this article, but it doesn’t state clearly why drug prices are a crime. The answer is tens of millions of Americans aren’t filling prescriptions because of them each year. Many get sick and some even die because of them. For some cancer patients, it’s extortion. “Give me the money,” pharma says. “Or die.” Your money or your life.

Still, we all know that a crime is an act that violates laws of a governing authority as proven through due process of those laws. And our laws allow the pharmaceutical industry to charge the prices referred to as a “crime” in Bloomberg.

That said, there is litigation targeting drug companies, pharmacies, and insurance companies/PBMs for violating laws to keep drug prices high. Examples include insulin price fixing, collusion between health insurers and pharmacies, and pharmacy kickbacks to PBMs. However, to an extent not found in Australia, Canada, New Zealand and the United Kingdom, U.S. laws permit—even encourage—increasing drug prices out of reach for patients who need them. Lawful but unjust.

It gets sicker and more unjust: technically, a patient who re-imports a medication from Canada because it’s her only affordable option is subject to jail and fines. No, that’s never happened, but it’s despicable that the law makes it a possibility while drug prices continue to climb.

Justice and law, when it comes to prescription drug prices in America, are fully out of whack.

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2019 Budget Bill Bumps up Part D Discounts by One Year

Celebrate Part D donut holeDue to a little provision in the 2019 budget bill passed by Congress today, fewer Medicare enrollees may need to look online to international pharmacies for lower costs. That’s because the Part D discounts mandated under Obamacare are being phased in a year earlier. These are discounts provided to enrollees who fall into the Medicare Part D coverage gap “the “donut hole”.

Without the new provision, people in the donut hole would be responsible for around 50% of the cost of their medication until 2020, when they would only need to cover 30%. Now they will only need to cover 30% in 2019 – a year early.

This is a small win but perhaps it was a consolation prize. Regardless, some drug price relief is always welcome. It’s the drug companies who are forced to cover these discounts so they’re probably none too happy about this. On the other hand, maybe there was a backroom deal. The Creating and Restoring Equal Access to Equivalent Samples Act (CREATES), which would have helped lower-cost generics come to market faster, was slated to be a part of this bill. CREATES had massive support from groups on the left and the right, but it was knocked out of the final bill.

I’m glad that older Americans get a small discount next year on prescription drugs, but I have the feeling we got thrown a bone.

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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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Doug Jones Wants to Lower Prescription Drug Prices

Doug JonesToday, Democrats are ecstatic, Republicans perhaps not so much, but one thing is certain: everyone’s wallets are cheering! The verdict is in: the state of Alabama voted Doug Jones to represent them as the next Senator of Alabama.

Put the Drama Aside…

You see, Doug Jones is a vote for expressly permitting your access to cheaper meds in Canada. “The Affordable and Safe Prescription Drug Importation Act” is a bill that Roy Moore would have most assuredly voted against, which is frankly unacceptable given the exorbitant prescription medication costs folks are facing at the local pharmacy counter every day.

(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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