More than 50 health professionals signed a letter addressed to President Donald Trump, members of Congress and the U.S. Food and Drug Administration (FDA) asking that we expressly permit personal prescription drug importation. The letter comes along the ever-swelling wave of patient and provider outrage against Congress’ and the president’s failure to act on drug prices, a result of the Big Pharma/U.S. politician relationship, which is only growing cozier.
The letter states:
“Our patients, who have purchased medications through the help of pharmacy storefronts or international online pharmacies verified by PharmacyChecker.com, have received safe and effective medications from legitimate pharmacies in Canada and several other countries. We respect that the FDA is charged with protecting our nation’s medicine supply from counterfeit and otherwise substandard drugs. However, there is no logical reason why the FDA should interfere with the delivery of safe and effective medications to our patients.”
Tagged with: doctors, FDA, Florida, healthcare providers, pharmacychecker recommended, prescription justice
This week, I attended ASOP Foundation’s symposium titled: “Spotlight on Illegal Online Sales of Medicine.” ASOP is short for the Alliance for Safe Online Pharmacies. That organization, which started with funding from Eli Lilly and the National Association of Chain Drug Stores, has often received criticism on these blog pages. Like other Pharma-funded initiatives, its goals are aligned with the pharmaceutical industry and one of its main objectives is lobbying against personal drug importation. It often conflates, through its public education programs, safe international online pharmacies with dangerous rogue websites. However, a good part of its work is helping raise awareness and policy development to stop rogue sellers of counterfeit and substandard medicines from harming patients, and that’s something PharmacyChecker is 100% behind.
Much of ASOP’s work was the brainchild of LegitScript, a founder of ASOP. Truth be told, PharmacyChecker is the expert in safe international online pharmacies and providing consumers with useful guidance about them, but LegitScript/ASOP are the experts in rogue online pharmacies and pushing policies to shut them down. It’s disheartening that they seemingly refuse to separate safe importation from rogue online drug sellers. But I’ll put that aside for now.
I’m going to focus today’s post mostly on presentations by two high-ranking FDA officials. The first was the morning’s keynote speaker, Donald Ashley, JD, FDA’s Center for Drug Evaluation and Research Director of Compliance. His focus was the FDA’s efforts to combat illegal opioid sales online and those being imported through international mail facilities. I’ve written about how such actions can be used against safe personal drug imports. While that would be unfortunate, Mr. Ashley was meticulous in communicating that his efforts are strictly focused on opioids: shutting down fentanyl and other opioid-selling sites; detecting and stopping illegal opioid imports; and, through the Office of Criminal Investigations, charging and prosecuting these online opioid drug dealers.
Tagged with: ASOP, Donald Ashley, FDA, Michael Kopcha, Office of Pharmaceutical Quality
The FDA’s recent press release announcing its activities in Operation Pangea XI, an enforcement operation to “crack down on websites selling illegal, potentially dangerous drugs; including opioids,” is conspicuously inaccurate about CanadaDrugs.com, which was forced to close its operations back in July. For a more general analysis of Operation Pangea XI, see my post from last week.
CanadaDrugs.com vs. CanadaDrugs
CanadaDrugs.com was the biggest Canadian online pharmacy for well over a decade. During its 17 years in business, it estimated that people ordered one billion dollars in medicines. During that time, not a single adverse reaction was ever reported by the FDA or any health agency. Their business relied on the fact that Americans are never prosecuted for personal drug importation. The law permits, and Congress has recognized the importance of, the FDA using enforcement discretion to allow personal drug imports so people can afford medicine.
Tagged with: avastin, canadadrugs, indictment, pangea xi
Last week, the FDA reported on its enforcement efforts against illegal and “potentially dangerous” online drug sales in Operation Pangea XI, a global initiative run by INTERPOL in cooperation with over one hundred drug regulators. Also, President Trump signed H.R. 6, The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. I wish it was all about stopping rogue online pharmacies and ending the opioid crisis, but it’s not.
How Pangea XI and the SUPPORT Act are Related
The FDA is highlighting the SUPPORT Act and its effort in Pangea as important parts of the solution to stopping illegal online sales of addictive opioid drugs. The SUPPORT Act gives the FDA new authorities to stop illegal drug imports. So, what does this have to do with safe personal drug importation from pharmacies that require a prescription?
Before continuing, I can’t help note and show you that INTERPOL’s Pangea is funded by drug companies for this work. It’s this Pharma-funded initiative in which FDA plays a crucial role. The FDA does focus resources on shutting down some bad rouge sites, but it seems to also assist PhRMA in ways that curtail online access by Americans to lower-cost medicines from pharmacies in other countries.
There seems to be a tug of war: FDA’s enforcement efforts against safe personal imports vs. FDA’s lawful use of enforcement discretion to allow safe personal imports.
Tagged with: Interpol, pangea, STOP Act, SUPPORT
Yesterday, with great public relations fanfare, a new report from President Trump’s HHS was released showing that drug prices in other countries are often half the price they are in America. Who would have known? Well, for starters, the millions of Americans who are forced to shop internationally in order to afford their meds. Prices in other countries are actually much less than half for many drugs, but this report only looked at drugs in Medicare Part B, ones administered in a clinical setting by a healthcare provider – not picked up at the pharmacy.
Trump’s rhetoric on drug prices is one of the few unifying issues in our deeply-divided country. Trump has stated on several occasions that the “drug companies are getting away with murder.” Murder. Now, while his administration hasn’t really done much at all on drug prices, the latest report puts it out there loud and clear: drug prices are insanely lower in other rich countries than here in the United States.
Tagged with: Alex Azar, part b, Part D, price controls, reference pricing, Stephen J. Ubl, trump
Not only is October American Pharmacists Month, a time to recognize pharmacists for the great care they provide to communities, but October 27th is also the Drug Enforcement Agency’s (DEA) National Prescription Drug Take Back Day.
The day is designed to highlight a program that provides a safe and responsible method for patients to discard prescription medications from their homes and learn more about the risk of abuse with controlled prescription medications. The DEA website has a collection site locator, where Americans can find the exact location to discard their medications safely. The website also has a Substance Abuse and Mental Health Service (SAMHSA) Behavioral Health Treatment Services locator, it’s confidential and helps individuals find resources in their area.
Tagged with: DEA, National Prescription Drug Take Back Day, overdose, SAMHSA
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