Earlier this month, the American Medical Association voted to support “in-person” personal drug importation from Canada so that patients can benefit from lower pharmacy costs. According to its press release, the new policy is a response to “intensified concerns that patient out-of-pocket costs for prescription drugs have hampered access to needed medications.” To say the least! A survey, published in Axios, showed that about 90 million Americans did not fill a prescription because of cost last year.
It’s good that the AMA is supporting Americans filling orders in-person at Canadian pharmacies, but its support is so limited… to the extent that it’s hard to tell what if any impact AMA’s recommendation could have to help more patients. Furthermore, the association appears to be confused about existing law.
First, the AMA’s support does not include Internet or mail-order pharmacy purchases from Canada. In fact, it opposes personal drug importation through Internet purchases “until patient safety can be assured.” Therefore, its proposed policy is likely to help only those who actually live near Canada. (more…)
Tagged with: American Medical Association, Axios, Customs and Border Patrol
As announced by HHS Secretary Alex Azar, the Trump administration is planning to force drug companies to include prices in their advertising. That means that, along with the long list of drug side effects that you hear during a TV ad, you’ll see the list prices. That list price is referred to as the wholesale acquisition cost, which is around the cash price you’d pay without insurance. Prices would have to be included in all ads for drugs covered by Medicare and Medicaid (i.e. pretty much all drugs).
I don’t particularly love this idea, but it is better than nothing.
The goal of this policy is to control drug prices by making them more transparent. Sound unlikely? It has a noble free market, pro-consumer ring to it, which I kind of like. It will be fun to see how this plays out, but it’s a minuscule policy move that won’t bring the kind of drug price relief that Americans want and need. In the proposed rule, Azar, or whichever of his staff wrote it, is all high and mighty about transparency and market efficiency:
“Markets operate more efficiently when consumers have relevant information about a product, including its price, as well as alternative products and their prices, before making an informed decision whether to buy that product or, instead, a competing one.”
At PharmacyChecker, we know a lot about the importance of drug price transparency. That happens to be one of the things we’re best at (along with verifying pharmacy practice standards). Our recognized forte is international pharmacy drug price transparency.
Here’s a scenario for you:
In this future world of Azarian drug price transparency, Jorge from Brooklyn will be watching the baseball game (maybe the Yankees in the World Series next year), and he’ll see an ad by Merck for the drug, Januvia. Jorge has just learned he has Type 2 diabetes and has a prescription. He’ll hear that Januvia can help lower his blood sugar, which is good. Then, he’ll hear that the side effects could include joint pain, a skin reaction requiring treatment in a hospital, and even death from pancreatitis. He gets that all these ads have to list those side effects.
Then he hears: it’s $550 for a one-month supply; but, wait, it will likely cost much less with insurance! That doesn’t exactly help. Jorge is one of 30 million uninsured Americans, and $550 is more than he can afford after paying his rent, groceries, gas bill, his daughter’s ballet classes, and his son’s asthma inhaler. Yes, he’ll hear there are Januvia patient assistance programs that might be able to help. Let’s hope so…because people often don’t qualify.
There’s no generic competition for this drug in Brooklyn. Unlike generic drugs, you can’t pharmacy hop for the best price or find a significantly lower U.S. price on the web. So what good is that transparency other than a minor slap on the hand to Big Pharma?
45 million Americans didn’t fill a script in 2016 because they faced similar situations to Jorge.
But there’s hope! When my fellow Americans visit www.pharmacychecker.com, they are blown away that the price of a drug is almost nine times higher in the U.S. than in Canada – and, yes, I mean Canada (not India or Turkey, where drug prices are even lower, and for the same drug).
On our website, Jorge learns that brand-name Januvia is $270 for a three-month supply if he orders it from Canada. Now that’s Drug Price Transparency! It’s a massive punch to the Big Pharma gut.
Januvia Prices in the U.S. vs. Canada
||Canadian Online Pharmacy Price
|Januvia 100 mg
Canadian pharmacy prices among verified international online pharmacies in the PharmacyChecker Verification Program are ones he can afford. If he cannot, then those same online pharmacies may also refer orders to pharmacies outside of Canada, which may have even lower prices.
Azar’s proposal shows just how vulnerable Americans are
To the credit of Azar’s proposed rule, it at least identifies how incredibly vulnerable Americans are to drug prices.
- Uninsured paying cash prices
- Insured finding that PBM formularies don’t cover all drugs
- Insured finding they must pay co-insurance of 30-60% (not just copays) on really expensive drugs (in the many thousands per month)
These coverage gaps affect tens of millions of people each year, which is why we have a crisis. Making drug companies note the price in TV ads while leaving the patient powerless to do anything stinks.
Interestingly, one drug company, Johnson & Johnson, warns that this is a bad idea because people might end up not taking their prescribed medications. The Onion couldn’t do better than this. It’s not The Onion, though. It’s Bloomberg: J&J Says Putting Drug Prices in Ads May Scare Away Patients.
From the mouth of Big Pharma…
Tagged with: Alex Azar, Drug advertising, Januvia
This week, our nation’s great senators passed a bill, the Opioid Crisis Response Act (OCRA), to fight back against the opioid epidemic. You think we’re stuck in partisan gridlock? Well, think again: the bill passed 99-1. This is how it goes down when Pharma is cool with a bill. Big Pharma can unite Congress like no other industry, organization or, certainly, president can. This bill passed unanimously (almost), because senators don’t want to vote against a bill that is seemingly dedicated to tackling opioid addiction. But some provisions, ones that may curtail access to safe personal drug importation, are unrelated to opioids and you can smell Big Pharma working behind the scenes.
There’s some easily digestible intrigue relating to this bill and personal importation, but the language itself is obscure and annoyingly technical as well.
Let’s start with the intrigue.
A bill numbered H.R. 6, passed the House in late June 2018. The bill was called: “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act.” [To find it via the link provided, click the bill text, and then use the dropdown to find the version of the bill on June 28th, 2018]. That earlier H.R. 6 included the following language:
“(c) DEFINITION. – For purposes of subparagraph (B), the term ‘pattern of importing or offering for import articles of drug’ means importing or offering for import articles of drug describes in subclause (I) or (ii) of subparagraph (B)(ii) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.”
That language applies to both the bill itself and the existing statute, which further complicates things, but the gist is simple:
The author of that language wanted to make clear that this legislation should not affect small, personal or household quantity medication imports.
After the bill passed, 396-14, it went to the Senate, specifically the Senate Committee on Health, Education, Labor and Pensions (HELP), led by the chair, Senator Lamar Alexander (R-TN) and ranking member, Senator Pat Murray (D-WA). In HELP, I believe that Senator Alexander crossed out H.R. 6 and added a whole new bill in the form of a substitute amendment. That substitute amendment, without vote or a committee conference report, removed the language above that was protective of personal imports.
Go to the bill H.R. 6. [After clicking the link, you’ll see “AMENDMENT” – “Strike all after the enacting clause and insert the following.” That’s what I mean by replacing the entire bill with a new one; one that contains new language and omits other language.]
This backroom editing and revising of bills often undermine the democratic process but is sadly commonplace in Congress. Large industry trade associations know how to play the game to make sure those revisions and edits work in their favor. There is no better player than the Pharmaceutical Researchers and Manufacturers of America (PhRMA) and their allies.
But what the hell does that definition above mean and pertain to anyway?
It relates to something called debarment. Under federal law, specifically Section 301 (cc) of the Food, Drug and Cosmetics Act, Title 21 U.S. Code 331, a person who is debarred cannot be involved in certain work relating to FDA-regulated industries.
There is mandatory and permissive debarment. We’re just concerned with permissive debarment here. Current law mostly calls for debarment of individuals who have committed felonies and misdemeanors – crimes. HR 6 amends this language by adding to that list:
“[a] person [who] has engaged in a pattern of importing or offering for import…adulterated or misbranded drugs”
And by adding the bolded text as you see below to define a Prohibited Act:”
“The importing or offering for import into the United States of an article of food or a drug by, with the assistance of, or at the direction of, a person debarred under section 335a(b)(3) of this title”
Let’s say you buy your cholesterol and asthma medication from Canada on a regular basis.
That’s a pattern. Under federal law, because of the Canadian label, the medications are misbranded, even if they are the exact same drug as the one sold here. In theory, this patient and/or a person who has helped that patient can be debarred from doing so.
There you have it. Now you see why that original language was in there to protect such people who import medications that are consistent with personal or household use by the importer – not resale.
Synthetic Trafficking and Overdose Prevention Act (STOP)
Another part of this bill that threatens importation are the provisions taken from the Synthetic Trafficking and Overdose Prevention Act (STOP Act). The STOP Act’s stated goal is to stop illegal imports of fentanyl and other drugs. The STOP Act is focused on making changes to our system of regulating international mail shipments. Small import packages come through international mail facilities without tracking in the way that FedEx, UPS, DHL packages are required by law to be tracked. If you order a drug from a Canadian pharmacy, the U.S. Postal Service delivers it to you. When Chinese fentanyl ingredient traders want to get stuff into the U.S., it also goes through the USPS via international mail facilities. So, the STOP Act creates new rules for the USPS to know what’s coming in with the goal of stopping illegal drugs.
The STOP Act can be great because it will be harder for opioid dealers in the U.S. to import the ingredients or finished opioid drugs that wreak havoc on our people. It’s potentially bad because the FDA very well might use this to stop “other drugs,” such as personal imports of lower-cost medicines, because it will be easier to do with the advanced data about incoming mail packages required under the new regulations. It’s certainly concerning because the drug companies and their allies have invested time and money to highlight, as a negative, that Americans receive their lower-cost medications via USPS.
Creating and Restoring Equal Access To Equivalent Samples Act (CREATES) vs. Higher Medicare Drug Prices
Now that different versions of the bill H.R. 6 have passed the House and Senate, the two chambers meet in conferences to create one version for the president to sign. To add insult to injury, behind the scenes, Pharma is trying to add language that would erase new discounts in Medicare Part D slated for 2019. On the other hand, drug price advocates are trying to get language in there to push through the provisions of the CREATES Act (Creating and Restoring Equal Access To Equivalent Samples Act).
Simply put, now, brand drug companies sometimes make it hard for generic drug companies to acquire the pharmaceutical samples they need to create a lower-cost generic. If CREATES goes through, generic drug companies could more easily obtain these samples. That would facilitate faster generic availability and save patients and taxpayers money: about $3-4 billion. The just outcome is Pharma losing its pitch to ditch the Medicare savings and then CREATES makes it in the bill! I’ve heard talk about horse trade.
What does this bill do to curtail the opioid epidemic? It will help, but it’s not even close to what is needed. I’m not going there at the moment, but here’s Politico’s take. Since there’s some good stuff in there, Congress feels obligated to go for it; so here we are. As I’ve shown you, Pharma’s many allies in Congress have used this bill to sneak in stuff that is unrelated to opioid addiction that Pharma wants – including taking a jab at importation and lower drug prices in other countries.
Tagged with: Lamar Alexander, opioid, Opioid Crisis Reduction Act, Patty Murray, Synthetics Trafficking and Opioid Prevention Act
Generic drugs often become available earlier in other countries and that means greater affordability. Generally, it’s a violation of a drug companies’ intellectual property rights when a company sells a generic in a country before the patent has expired. But what happens if you import a generic version of a drug, one that is lawfully-made and sold in a country where it is available but still on patent here, to fill a prescription? Are you committing an intellectual property violation?
According to a side agreement (of the General Agreement on Tariffs and Trade) among countries party to the World Trade Organization, called TRIPS (Trade-Related Aspects of Intellectual Property Rights), countries are not obligated to enforce IP laws for small importations of goods, which include pharmaceuticals.
You can find this in Part III, Enforcement of Intellectual Property Rights, Article 60:
De Minimis Imports
Members may exclude from the application of the above provisions small quantities of goods of a non-commercial nature contained in travelers’ personal luggage or sent in small consignments.
The “above provisions” refer to enforcement actions against intellectual property violations that involve goods crossing borders (in person, by plane, sea, through the mail, etc.). If you read closely, it includes the word “may.” That means, in theory, you could be accused of an IP violation, but I know of not a single instance of that happening to an individual importing a medicine for personal use.
What is clear is that there’s general agreement (no pun intended) that individuals should not be subject to IP enforcement actions for importing a product for personal use. When it comes to a life-saving medicine, this seems like common decency – even natural law.
Tagged with: article 60, intellectual property rights, patent, TRIPS, WTO
Azar is proposing a discussion about allowing imports of single-source drugs to lower costs
Yesterday, Health and Human Services Secretary Alex Azar announced that he was tasking FDA Commissioner Scott Gottlieb with forming a working group to explore how drug importation could be used to lower prices. See Gottlieb’s remarks on the proposal.
The crux of the proposal is very narrow. Azar is considering allowing imports of foreign versions of off-patent medicines that only one manufacturer (also referred to as “single-source” drugs) is selling in the U.S. market. That would be a drug without any competition where the company with the marketing license jacks the price. Keep in mind that he has simply called for a working group to discuss it.
I’m getting asked a lot of questions about this proposal and realize that many people, including well-informed journalists and policy professionals, don’t really get this.
People who already import medicines, through buying them online or carrying them home from Canada to save money may also be confused!
So, to help any and all understand what HHS and the FDA are considering when it comes to drug importation, below are some important takeaways. My general take, as noted in the Washington Post, is that it’s a step in the right direction (if it goes forward), and it could help educate the public about greater potential benefits to larger scale importation.
- This is not legalizing buying cheaper, FDA-approved meds from retail pharmacies in Canada online or otherwise.
- Millions of Americans already benefit from importing lower-cost, safe and effective medicines for personal use. They do this despite the existing federal prohibitions and scare tactics employed by industry-funded groups to deter such purchases. To do so safely, they stick to credentialed online pharmacies, such as those verified by PharmacyChecker.com. Today, Roger Bate, who is affiliated with the American Enterprise Institute, wrote: “All the FDA has to do is allow Pharmacy Checker to do its job and tell the American people about it.”
Tagged with: Alex Azar, Daraprim, emflaza, gleostine, Roger Bate, Scott Gottlieb, single source
The relentless deluge of Big Pharma bunk in the media continues. Dr. Kristina Acri, an associate professor of economics at Colorado College, recently published an op-ed in a local Colorado newspaper – The Pueblo Chieftain – called “Drug importation bill a poison pill.” Dr. Acri is against a state bill supported by Congressman Jared Polis (D-CO), who is also running for Governor, that would allow the wholesale importation of lower-cost medication from Canada. This bill is similar to one recently passed in Vermont, which came from drug importation model legislation created by the National Academy for State Health Policy.
The Pueblo Chieftain did not include that Dr. Acri has worked for the Pharmaceutical Researchers and Manufacturers of America. She is also known as a staunch supporter of the drug industry’s intellectual property rights agenda.
Congressman Polis was given ample opportunity to respectfully refute Dr. Acri’s stance in his own op-ed called “A safe way to lower drug costs.” I liked his op-ed. Feel free to read both of their positions, but one thing he wrote about Dr. Acri’s piece was wrong: “I very much appreciate Dr. Acri offering a constructive, fact-based critique that enriches our community’s discussion of this important issue.” Her piece was decidedly not fact-based, and it needs to be called out. Let’s break it down.
First, she writes: “A study by the Organization of Economic Co-Operation and Development showed that counterfeit drugs accounted for 2.5 percent – or $461 billion— of the world drug market in 2013.” I looked at that report, and it states that in 2013 international trade in counterfeit and pirated goods (not just drugs) “represented up to 2.5% of world trade, or as much as $461 billion.” That section is referring to total world trade – not solely pharmaceuticals. That total includes all counterfeit products ranging from “high-end consumer luxury goods such as watches, perfumes or leather goods, to business-to-business products such as toys, pharmaceuticals, cosmetics and foodstuffs.” Over the years, the industry has plucked numbers out of thin are on the topic of counterfeit drugs, getting “facts” to stick in the media, but this one really took the cake.
See the study for yourself: https://read.oecd-ilibrary.org/governance/trade-in-counterfeit-and-pirated-goods_9789264252653-en#page12. (more…)
Tagged with: colorado, Congressman Jared Polis, Dr. Kristina Acri, nashp, state importation bill