#PharmacyChecker Blog

[trimixdr]

Where to Buy Trimix Online: Trusted E-commerce Sites and Deals

In the evolving landscape of pharmaceutical purchasing, the quest for convenience and reliability has never been more critical. Among the various medications available online, Trimix—a compound used in the treatment of erectile dysfunction—stands out due to its effectiveness and the complexity of its procurement. For those seeking to buy Trimix online, it's essential to navigate the marketplace with caution, ensuring that the source is both reputable and trustworthy. This blog will guide you through the most reliable e-commerce sites for purchasing Trimix and highlight where you can find the best deals.

Understanding Trimix

Before diving into where to buy Trimix online, it’s crucial to understand what it is. Trimix is a compounded medication made up of three ingredients: alprostadil, papaverine, and phentolamine. It is used primarily to treat erectile dysfunction (ED) and is administered via an injection directly into the penis. Trimix is known for its effectiveness, especially for those who have not had success with oral ED medications.

The Importance of Choosing a Trusted Source

Given the nature of Trimix and its administration, it’s vital to purchase it from a reputable source. Here’s why:

Safety and Authenticity: Online pharmacies can vary significantly in terms of product quality. Purchasing from a trusted e-commerce site ensures that the Trimix you receive is authentic and safe to use.

Legal and Regulatory Compliance: Trusted e-commerce sites comply with regulations that govern the sale of prescription medications. This ensures that the product has been manufactured and handled correctly.

Confidentiality: Reputable online pharmacies offer secure transactions and protect your personal information, a key consideration for many patients.

Tips for Finding the Best Deals on Trimix

Compare Prices: Use price comparison tools to find the best deals. Sites like Pharmacy Checker and GoodRx can help you compare prices across different pharmacies.

Look for Discounts and Coupons: Check if there are any available discount codes or coupons for Trimix. Many online pharmacies offer special promotions that can lead to significant savings.

Sign Up for Alerts: Many e-commerce sites and online pharmacies offer newsletters or alert systems. By subscribing, you can stay informed about the latest deals and offers on Trimix.

Check Insurance Coverage: Some insurance plans may cover the cost of Trimix or offer reimbursement. Check with your insurance provider to see if you’re eligible for any coverage or discounts.

Read Reviews: Before making a purchase, read customer reviews to ensure that the pharmacy you choose is reliable and provides quality products.

Conclusion

Buying Trimix online requires careful consideration to ensure that you’re getting a safe, effective, and reasonably priced product. By selecting trusted e-commerce sites such as HealthCare.com, PharmacyChecker, GoodRx, Blink Health, and Walgreens, you can confidently procure Trimix while taking advantage of various deals and discounts. Always prioritize safety by verifying the legitimacy of the pharmacy and checking for customer reviews.

In addition, use price comparison tools, look for discounts, and stay informed about insurance coverage to make the most of your purchase. With the right approach, you can effectively manage your erectile dysfunction treatment with Trimix, enjoying the convenience and reliability of online shopping.

For more information or to schedule a consultation, visit Precision Trimix Dr. Take the first step towards a fulfilling and confident tomorrow.

📞 Call us now at +1 (561)6770094 🌐 Visit us at www.trimixdr.com 📍 Location: 162 Village Blvd APT H, Tequesta, FL 33469, United States

[lonnysapotheek]

State Drug Importation Program Relabeling Requirement Says It All

For the benefit of consumers, I published a longish but straightforward explanation of the state wholesale drug importation bills, laws, and programs and how they differ from personal importation. I reviewed the drug relabeling section of Florida’s Drug Importation Program submission to the U.S. Department of Health and Human Services, and it really tells a story. Many if not most of the drugs that states propose to import from Canada are not made in Canada or the U.S. Both countries import a majority of their pharmaceuticals. They often come from the same countries and factories and are the exact same drugs. The reason the prices are so high in the U.S. is usually blamed on patents, which lead to what some call monopolistic pricing. Another reason drug prices are so much higher in the U.S. is that drug manufacturers have had a monopoly on commercial importation. It’s a very special protection that states are trying to remove through these programs.

Florida’s submission includes the example below for Teva’s generic version of Atripla (efavirenz/emtricitabine /tenofovir), which treats HIV.

Product label table from Florida’s drug importation program submission

As the label indicates, this generic Atripla is made in Croatia. Florida shows us:

The standard U.S. label

The proposed U.S. SIP label

The Canadian label

Notice that the middle one, the SIP example, provides the following disclaimer:

“This drug was imported from Canada without the authorization of Teva Pharmaceuticals USA under the State of Florida Section 804 importation program.”

That’s the name of the game here! There’s no longer a patent on Atripla in the U.S., for which there is an approved generic… Teva’s. They make it in Croatia and ship it to Canada and the U.S., and probably all over the European Union as well. When it’s sold in the EU, wholesalers have the right to sell it to whomever they want within the EU. They don’t need the permission of the drug company who they just paid for the product. It’s called parallel trade; it results in price competition – and that’s what states are doing with Section 804.

The best argument against the state drug importation programs is not safety: it’s that Canada is too small a market and its government is rightfully concerned about drug shortages. With some interesting exceptions in Florida and California, most state drug importation programs only look to Canada. There’s no good reason not to expand beyond Canada, especially to the EU. To do this for commercial drug importation would require amending Section 804 and that should be done. It could be done now for personal drug importation, under which the law provides adequate flexibility.

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[lonnysapotheek]

Sen. Richard Burr’s Love Affair with Big Pharma: The Ghost of Billy Tauzin

These are unique times we’re living in, so before I criticize this guy for his Big Pharma love, I feel compelled to hand him a well-earned compliment: Senator Richard Burr (R-NC) acted heroically in voting to impeach former President Trump in the wake of the violent January 6th assault on Congress. Whether or not you agree with Burr’s vote, history shows politicians rarely cross the aisle to impeach someone in their own party. Senator Burr’s vote was courageous. I stand by that even though he decided not to run for re-election in 2022.

People (like me) often accuse politicians of carrying water for Big Pharma so that they will receive large campaign contributions from the industry. During Sen. Burr’s last campaign in 2016, he received over $200,000 in campaign contributions from drug companies. These contributions contributed to him receiving an F grade on drug prices on the Prescription Justice Congressional Report Card. Even though he is not facing an election in 2022, Sen. Burr continues to espouse public policy beliefs and talking points of the multinational pharmaceutical industry. So maybe he is genuinely a believer in the pharmaceutical industry being able to charge anything it wants for life-saving medications because that’s the business model supposedly supporting wonderful advances in biomedical research. Maybe.  

I read in STAT News that during the Senate Committee Health, Education, Labor and Pensions (HELP) hearing dedicated to questioning California AG Xavier Becerra, President Biden’s nominee for Secretary of the Department of Health and Human Services, Sen. Burr, the ranking member, was strongly critical of Becerra. Specifically, Burr went after Becerra for supporting an interpretation of the Bayh-Dole Act that would allow the government to override a patent on a drug developed with U.S. taxpayer funding viewed to be exorbitantly priced and allow the manufacture of lower-cost generic versions:

“American innovation and ingenuity are rescuing us from the devastation of a global pandemic…Your actions as attorney general for California and your tenure in Congress reveal somewhat of a disregard for the value of this ingenuity, calling for policies that undo decades of investment in and support of Americans’ biomedical research.”

Apparently, Sen. Burr believes that drugs developed with our money should still be priced out of our reach. Or maybe he’s looking at his exit strategy and thinks that continuing to drink the Kool-Aid will pay off. That’s where the ghost of former Congressman, Rep. Billy Tauzin (R-LA) emerges.

In 2003, Rep. Tauzin, Chairman of the House Committee on Energy and Commerce was instrumental in shepherding the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA). The MMA was a huge boon for the pharmaceutical industry, which lobbied like crazy to get what it wanted in the bill. Yes, the MMA introduced Part D of Medicare, pharmacy benefits for older Americans. However, it also stuck taxpayers with the bill while continuing to require painful out-of-pocket spending by people on Medicare. Infamously, it created a ban on Medicare negotiation of drug prices. Right after the bill passed, Tauzin left Congress to become executive director of the Pharmaceutical Researchers and Manufacturers of America for an annual salary of $2 million! It remains the quintessential example of a perverse revolving door from government to big industry.

And that brings us back to Senator Burr. One of the complaints among some Republicans on the HELP committee about Becerra is that he’s a lawyer, not a doctor. One of them even said that a lawyer running HHS is like a doctor running the Department of Justice. [I won’t digress on the obtusity of that analogy.] Burr actually juxtaposed Becerra’s experience as weak compared to the “extensive career in the pharmaceutical sector” of Alex Azar, who was president of Eli Lilly USA before becoming Trump’s HHS Secretary. Azar is a lawyer, too!

I can tell you this: it should be illegal for Sen. Burr to work in any way for the pharmaceutical industry for (at the very least) five years after leaving office. He will have lobbying restrictions under federal law, but they do not prevent him from working for Big Pharma when he leaves office. We’ll just have to see.

Whatever happens, Burr will be remembered for that vote to impeach Trump. But here’s a political twist: It’s politicians just like Burr who turned voters against “moderate” Republicans and blindly embrace the nationalist and populist Trump. Burr believes in democracy and capitalism, but wrongly views the needs of multinational corporations as central to America’s success, to the detriment of the majority of citizens. His faith in Big Pharma personifies that troubling reality.

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[lonnysapotheek]

New Op-Ed in The Hill Advocates Drug Importation and Most Favored Nation Policies

Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice

Professor Stephen Salant. Professor Emeritus of Economics, University of Michigan

This week, I’m proud to announce that I teamed up with Stephen Salant, PhD, professor emeritus of economics to the University of Michigan, to write an op-ed called “The one-two punch to knock out high drug prices.” Professor Salant was also an economist with the Federal Reserve Board and the Rand Corporation. Our article, published today in The Hill, recommends legislation and regulatory reforms that would promote safe prescription drug importation and implement a most favored nation system of drug pricing for Medicare. The recommendations are based on executive orders from the Trump administration and Democratic legislation from the previous Congress. They should have intense bipartisan support.

Lots of others have written to promote similar reforms, but our article employs new economic theory articulated by Dr. Salant in a paper called Arbitrage Deterrence: A Theory of International Drug Pricing. You can read the op-ed and the paper (if you have strong math skills) but the gist is that: 1) Promoting drug importation, both personal and wholesale would lead to lower domestic but higher foreign drug prices, 2) Simultaneously implementing a strong system for international reference pricing would curtail the aforementioned drug price increases and create a noble cycle of lower and reasonable foreign and domestic prices, and 3) the savings to the U.S. government would be more than enough to subsidize biopharmaceutical research to offset lower R&D investments from drug companies.

Read the op-ed here.

Read Professor Salant’s paper here.

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[lonnysapotheek]

State Drug Importation Bills Just Got More Personal in California

With lies and deception, Big Pharma has used the threat posed by rogue websites and counterfeit drugs to push back against U.S. state legislation to gain access to lower drug prices in Canada. Regardless, several states have passed laws toward creating importation programs: Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont. Simple summary: Canada’s brand drugs are priced much lower and states want access to them. These state laws have largely been confined to wholesale drug importation. That is, until this week when California Assemblymember Sydney Kamlager introduced the Affordable Prescription Drug Importation Act, AB 458. The bill not only calls for wholesale importation from Canada – but also personal drug importation from Canada and other countries, subject to Section 804 of the Food, Drug, and Cosmetic Act. It’s about time!

The bill states:

“This bill would authorize an individual to import a prescription drug only for use by that individual or a member of that individual’s immediate family from a foreign pharmacy if specified requirements are met. The bill would prohibit an individual from, among other things, importing a prescription drug for resale or a controlled substance.”

This is a huge step in the right direction because Americans are already buying medications internationally. Millions have done so from safe international online pharmacies – and the law technically permits this through enforcement discretion, but they should have “express permission.” As I stated in a press release yesterday:

“Assemblymember Kamlager recognizes that millions of Americans are already buying medications internationally because they can’t afford them here… AB 458 gives those people a voice by finally providing them with express permission to do so.”

To date, state laws have strongly relied on model state legislation on drug importation drafted by the National Academy for State Health Policy (NASHP). The NASHP model legislation is focused solely on wholesale importation from Canada and explicitly does not cover personal dug importation. Florida’s law opens the door to importation beyond Canada – but the importers cannot be individuals.

As I understand it, NASHP believes that a regulatory framework for safe wholesale drug importation is more practical. The channel of importation is confined to a wholesaler in Canada exporting FDA-approved drugs to a state-licensed wholesaler in the United States. Drug company scare tactics about rogue websites won’t work here.

You can expect Big Pharma to attack the California bill. The hope is that a real, objective analysis of personal drug importation will occur in the California legislature.  Americans can and do safely buy much more affordable prescription drugs from licensed pharmacies in other countries through travel and ordering online. There’s no gray in that statement. PharmacyChecker’s verifications help by providing them the information to do so safely. The government can and should do this, too.

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[lonnysapotheek]

Top 60 U.S. Brand Name Drug Prices are 75% Lower Internationally, According to Rand Corporation Study

Original post found on PharmacyChecker.com.

The Rand Corporation has released an impressive study showing that brand name drugs cost far more in the United States than in other countries – on average 344% more. For those of you looking for a methodologically strong analysis of international drug prices and a history of related studies, this is the report for you. In looking at all drugs, brand and generic, the percentage goes down to 256%. That’s because, as the report shows, generic drugs in the U.S. were found to be priced at 86% of those in other countries. The report was based on drug prices from 2018.

The report’s title is very descriptive of its contents: “International Prescription Drug Price Comparisons: Current Empirical Estimates and Comparisons with Previous Studies”

Explaining the report’s approach in the simplest terms: it accomplishes its main objectives by creating price indices for 32 member countries of the Organisation for Economic Cooperation and Development (OECD) and comparing them for all drugs, brand name and generic. That’s the report’s main focus. It has additional results for other categories, notably biologic drugs and the top 60 drugs in terms of sales. For biologics, which are generally the most expensive prescription products, U.S. prices are on average 295% the international price. For the top 60 drugs by sales, U.S prices are on average 394% higher.

Using some simple math, let’s turn these numbers into percentage savings figures that Americans, who are angry about high drug prices, want to know about. The average savings for brands is 71%; for all drugs (brand and generic), the savings is 61%; for generics, 19% (because U.S. generics are usually cheaper); the average savings for biologics is 66%; and, for the top 60 drugs by sales, 75%.

Rand Corporation – United States vs. International Drug PricesCategory of AnalysisU.S. PremiumInternational SavingsBrand Drugs344%71%Overall256%61%Generic Drugs84%-19%Biologics295%66%Top 60 Drugs by Sales394%75%

It’s that last figure to which I turn my attention now. A key research point of the report is that it is the first substantive, methodologically rigorous analysis of international drug price comparisons in ten years. In short, this deep dive is long overdue. I agree, but other reports in the interim have shown strikingly if not identical results:

In 2019, the Congressional House Ways and Means Committee released a report comparing U.S. prices to those in 11 high-income countries and found that the average savings was 75%! The Committee report looked at the top 79 drugs by sales sold in Medicare. The top 60 drugs by sales category from the Rand report were likely included among these 79 drugs. Those were based on ex-factory prices, meaning the prices charged by drug manufacturers paid by wholesalers, for example.

PharmacyChecker.com looked at online retail prices for those drugs included in the Committee’s reports that are available for sale through retail mail order internationally and found the average potential savings were 72%.

The pharmaceutical industry flacks have already criticized this report for using drug company list prices, which do not include the rebates provided to third parties, most notably pharmacy benefit managers, referred to as net prices. Big Pharma thinks that’s not fair! Here’s a retort. The report actually DOES address net prices and includes an estimate of the price differentials based on additional analysis. Compared to net prices for brand name drugs U.S. prices are still 230% higher than the average of OECD countries. That’s without doing similar adjustments for net prices in any of the other countries. Furthermore, there are about 35 million uninsured and tens of millions more underinsured Americans who are potentially subject to the list price without rebates, so let’s stop pretending that list prices don’t matter.

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[lonnysapotheek]

Drug Importation Under Biden?

Drug importation, by which I mean the process of buying much less expensive and equally safe prescription drugs from other countries, may see more sunlight under the Biden administration. For many drugs, the prices are frequently 90% less in other countries. Biden included drug importation among several policies he plans to pursue to lower drug prices. There’s momentum on drug importation from the Trump administration in the form of:

An executive order calling for drug importation

A final rule by the U.S. Food and Drug Administration to allow wholesale importation from Canada

A request for proposal for personal drug importation programs

a request for proposals relating to the importation of Insulin

The question remains if Biden will prioritize these initiatives. The political and policy climates are favorable for him to do so. Importation is broadly popular among Republicans and Democratic voters. Lowering drug prices is a central health care concern in America. Drug importation has incredible potential as an effective policy to end the price discrepancies Americans face with other citizens in other high-income countries.

Veterans of this issue like me are sensitive to the history here from the Obama-Biden years. Obama famously made a deal with Big Pharma in which his administration backtracked on plans to reform drug importation laws and allow Medicare to negotiate with drug companies to lower drug prices. In exchange, Big Pharma supported Obamacare and helped secure its passage. Caving to Big Pharma is politically deadly and the Democrats will have less appetite to do so now than they did in 2009.

Finally, Biden’s call for unity, which I strongly support and admire, is at play here. Almost all voters want to see action on drug prices generally, and that includes importation. In drug importation, Biden finds a cause for all Americans to get behind.

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[lonnysapotheek]

Twitter’s Trump Ban and Big Pharma’s Online Censorship

For someone who believes that Donald Trump’s actions, especially recent ones, have threatened the core of our democracy, it’s difficult to admit that the Twitter ban against him strikes a nerve with me. Getting right to the point: in the summer of 2018, Instagram shut down PharmacyChecker’s account. PharmacyChecker, which I co-founded in 2002, is a small, independently-funded online pharmacy verification and drug price comparison website. One of its claims to fame is providing information for consumers that can help them safely obtain lower-cost prescription drugs from other countries. PharmacyChecker helps people avoid rogue pharmacy websites and save money. So why did Instagram shut it down?

Germane to the matter is the fact that under most circumstances federal law prohibits the importation of prescription drugs for personal use. However, federal law makes many allowances to permit it anyway, despite the prohibitions. Tens of millions of Americans have imported medicines for personal use and none have been prosecuted for doing so. PharmacyChecker does not import, sell, distribute, process orders for medication in any way. It provides information. That information may be controversial but it’s not illegal. Nonetheless, it poses a threat to the pharmaceutical industry, which needs Americans to pay the highest prices on drugs to maintain their incredible profit margins. You see where this goes.

As I wrote two years ago about this…

“The pharmaceutical industry, generally, does not like our company [PharmacyChecker]. As an extension of that feeling, the FDA doesn’t love us either. Basically, we are in Big Pharma’s crosshairs because the information we provide helps people find more affordable medicines from other countries and import them for personal use.

But is that a reason for Instagram to shut down our account!? That action is nothing less than corporate-inspired, government-encouraged censorship.”

Consequently, PharmacyChecker later filed a lawsuit against several organizations and companies funded by or allied with large pharmaceutical companies through trade associations or non-profit organizations. It alleges that such groups have illegally colluded to suppress PharmacyChecker’s information by corralling large Internet companies to do their bidding.

As I write this, if you go to the search engine Bing and search for PharmacyChecker, you’ll find a pop-up warning next to organic search results, which blocks the link to PharmacyChecker.com. Why? PharmacyChecker is on a list of “Not Recommended Sites” published by the National Association of Boards of Pharmacy through a program it runs that was funded with a grant from Pfizer.

These pharmaceutical industry actions are extralegal against PharmacyChecker and flout norms of due process. This is a similar argument that Trump is making against Twitter.

Twitter’s position is that the information published by Trump violates its Glorification of Violence Policy. Twitter states: “We have permanently suspended the account due to the risk of further incitement of violence.” I’m sympathetic to that position. However, Twitter is a private company, which has the power to substantially curtail the ability of the U.S. president to communicate, and that scares me. Let’s flip this…

In 2018, Twitter suspended the accounts of 80 left-leaning activists from the Occupy Movement with a social network of 5 million people, according to Wired Magazine. Twitter did not give a reason.

Instagram has the ability to shut down accounts of businesses and people without giving them a reason or with any viable due process opportunity. Bing can post warnings against websites because its commercial interests may be intertwined with doing so, even if it’s wrong. Google can delist websites from its search engine with no accountability. Etc. Don’t even get me started on Facebook (which of course owns Instagram).

I’m not saying we should allow any content on the Internet. Not at all. Child porn; terrorist networks; and drug dealer websites are all quintessential examples. Should Twitter allow the leader of a country to lie to tens of millions of people in a manner that leads them to anger and violence?  I don’t think so. But there needs to be standards and accountability; without them, such actions to protect our democracy will surely undermine it.

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[lonnysapotheek]

Drug Prices Are Up Again in 2021 and Canada’s PMPRB is On My Mind

This week the prices of over 500 drugs went up in America, according to drug price transparency non-profit organization 46Brooklyn. This happens every year, usually coinciding with shouts of anger and disgust with the pharmaceutical industry’s greed. The shouts are muted this year, probably because, like it or not, we’re counting on Big Pharma to manufacture enough Covid-19 vaccines to end the pandemic. But the battle against high drug prices continues. Godspeed.

The median price increase reported was 4.6%, slightly lower than last year’s increase but about eight times the estimated inflation rate for 2020 of 0.62%. If you’re thinking I’m going to start talking about importing drugs from Canada now, you’re wrong – as helpful as that remains for Americans who go that route individually. [There’s an importation surprise at the end of this post for you, however.]

I’m thinking about the public health prism through which Canada views drug prices. I like the sound of that. Public health prism. What the hell does that mean? Well, I was perusing the updated guidelines on drug prices published by Canada’s Patented Medicine Prices Review Board (PMPRB) and one sentence stood out:

“The PMPRB’s existence as the only sector-specific price ceiling regulator under the Act reflects a recognition by policy makers that the unfettered ability to set prices for patented medicines is not in the public interest given the unique harm that can ensue if consumers are made to pay excessive prices for them.” 

The public health prism through which Canada views drug prices is one where “the unfettered ability to set prices for patented medicines is not in the public interest.” The PMPRB is a quasi-governmental entity tasked with preventing excessive drug prices in Canada. Its creation was mandated under Canada’s Patent Act, as amended in 1987, and it is independent of Health Canada. Notice the phrase “set prices”. Whatever drug price increases happen in the U.S. – and they are slower than last year – drug companies set prices way higher in the U.S. than in Canada. The harm to Americans is unique in that due to these high set prices, we forego filling prescriptions at rates far higher than in any other high-income country.

It may surprise you that Canada’s drug prices are higher than in most other countries. They are done with that. One of the main mechanisms for preventing excessive drug prices in Canada is to set prices based on the average prices among a basket of other high-income countries, referred to as international reference prices. Last year, the PMPRB dropped the U.S. and Switzerland from the basket of countries, the only countries with higher drug prices on average than Canada, and added countries with lower prices: Australia, Belgium, Japan, the Netherlands, Norway, and Spain. The PMPRB11 basket of countries now includes Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden, and the United Kingdom.

The idea for creating a drug price review board in the United States is not new. In 1993, former Congressman Pete Stark (D-CA) introduced the aptly called Prescription Drug Prices Review Board Act of 1993.Apparently, the Clinton administration was supportive of the idea at the time, but according to the New York Times form 1993, “under heavy lobbying by the drug industry, the Administration has apparently backed away from the idea…”

Flash forward 23 years: Congresswoman Rosa DeLauro (D-CT) introduced the Prescription Drug and Medical Device Price Review Board Act of 2016 (H.R. 6501). The bill would establish the U.S. version of the Canada’s PMPRB. Its summary states:

“The board must establish a formula for determining whether the average manufacturer price of a prescription drug or medical device over an annual quarter is an excessive price.”

The bill has a special treat for Americans who believe they simply should not pay higher prices for drugs than in other countries. The bill states that the board “shall promulgate regulations permitting individuals to safely import from an approved country into the United States prescription drugs, and devices, that are comparable to prescription drugs, and devices, for which the Board makes a final determination that the manufacturer is charging or has charged an excessive price in violation of section 5(a) of the Prescription Drug and Medical Device Price Review Board Act of 2016.”

Could we get this type of legislation across the finish line?

Yes, Georgia’s on my mind, too…

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[lonnysapotheek]

Good Judgement; Bad Judgment on Personal Drug Imports

Here’s a kind of funny story to end the year with. I make a big deal on these pages about the decriminalized reality of personal drug importation. Federal law prohibits under most circumstances importing prescription drugs for your own use, but people are never busted for it. I’ve been around this a long time and I mean never. But that’s for personal use only. Recently, 20 U.S. air marshals in Dallas, Texas were disciplined for “smuggling” Viagra into the United States. They bought it at lower prices outside the U.S., brought it back, and gave it to their colleagues or sold it for a “small profit,” as reported in Yahoo News. So, are they in any real trouble?

It appears the answer is not really—at least not yet. The names of the air marshals are not public because they have not been charged with a crime. Some were suspended for a few days. One resigned. No one was terminated. However, two may be terminated based on “evidence uncovered during the investigation.” I would guess that those two were dabbling in the resale of stronger pharmaceuticals.

The scandal is referred to as “Bonergate”. The main thrust of the news coverage is that many of the 3,000 air marshals tasked with protecting flights from terrorism in the wake of 9-11 have been outed for various misdeeds. I’m going to remain agnostic on that issue. One comment made by Bill Beller the air marshal chapter president for the Federal Law Enforcement Officers Association is worthy of note:

“We have pride in our positions, and some people — whatever they did — I believe it was an error or error in judgment…”

Maybe. In contrast, Americans are using good judgment when buying medications for their own use from other countries because they can’t afford it here, as long as they do so wisely from licensed sources and possess a prescription for those medications. Bonergate may be funny, but the laws that curtail safe personal drug importation are no joke. Especially not to the millions of Americans who have to skip medications each year due to domestic costs. Big Pharma, on the other hand, is laughing all the way to the bank.

Happy New Year.

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[lonnysapotheek]

Wishing You More Affordable Medicine This Christmas

With some stops and starts, this blog has become far more focused on policy, regulatory matters, law and politics — and less on everyday consumer issues relating to drug prices. With Christmas upon us, I want to extoll PharmacyChecker.com’s simple core mission: make it easier for Americans to pay for their prescription drugs. Ask PharmacyChecker, the consumer journalistic section of PharmacyChecker, has a great piece up today called The Gift of Low Drug Prices. It speaks volumes about that mission.

Merry Christmas, America. 

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[lonnysapotheek]

PhRMA’s Lawsuit Against Section 804 Ignores Statute’s Permissive Position on Personal Importation

In its lawsuit to stop wholesale drug importation programs that could help lower U.S. drug prices, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) may be stepping on its toes in helping to allow more personal drug importation. Last month, along with co-plaintiffs Partnership for Safe Medicines (PSM) and Council for Affordable Health Coverage (“CAHC”), PhRMA sued the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to invalidate the certification by the HHS Secretary Alex Azar that drug importation from Canada is safe and will achieve savings for the American consumer.

In late September, Secretary Azar, in a final rule, certified that importing drugs from Canada, subject to Section 804 of the Food, Drug and Cosmetic Act (Section 804), 21 U.S.C. 384, Part L, poses “no additional risk to the public’s health and safety” and will “result in a significant reduction in the cost of covered products to the American consumer.” Those were the two certifications needed to allow a new wholesale drug importation channel.

Section 804 clearly distinguishes between wholesale (“commercial”) importation (subsections b-h) and personal importation (subsection J). As explained below, the standard for allowing personal importation is different. While PhRMA does not want either wholesale or personal importation to lead to lower drug prices, certain legal arguments it employs in its lawsuit may help the cause of expanding personal drug importation. Namely, personal drug imports can be permitted if they don’t pose an “unreasonable risk” to the patient; not so for wholesale imports (drugs that are resold). PhRMA ignores this.

The final rule identifies in detail the parameters of authorized importation. In summary: wholesale imports of qualified drugs by non-federal entities, such as states and tribes, subject to meeting safety requirements found in Section 804, who have submitted proposals that meet the requirements, are now allowed.

In contrast, the rule stated that it was not implementing personal drug importation provisions of Section 804. The main reason for not doing so, according to the proposed rule, is safety threats from rogue online pharmacies. While evidence shows that prescription drugs ordered from safe international online pharmacies help Americans save money, rogue sites are a real threat. I wish the Secretary had made the distinction, but that’s beyond the scope of this post.

PhRMA argues that Section 804 does not allow the Secretary to permit wholesale importation but neglected to make the same assertion in relation to personal drug importation. The court filing reads:

“Section 804(l)(1) precludes the Secretary from certifying only commercial importation, but not personal importation. By its terms, Section 804(l)(1) requires the Secretary to certify that ‘implementation of this section’ will satisfy the safety and cost criteria in subparagraphs (A) and (B). Secretary Azar did not certify “implementation of this section” but only commercial importation under subsections (b) through (h).”

To this point, Section 804 does not go into effect without the certifications on safety and savings for wholesale and personal importation. PhRMA’s point appears to be that even if wholesale importation did meet the safety threshold (which it argues it does not) required under Section 804, personal importation has to as well. And because it doesn’t, according to the PhRMA, none of Section 804 can effective. Here is where PhRMA fails to mention the different safety thresholds identified in Section 804 between wholesale and personal importation.

Unrelated to the wholesale drug importation provisions of Section 804, Part J states that personal importation, based on enforcement discretion, should be allowed as long as the import does not pose an “unreasonable risk” to the patient. In other words, it doesn’t make personal importation expressly legal like wholesale importation; it permits otherwise illegal importation for individuals.

I believe this part of the law has always been effective in terms of expressing the will of Congress even in the absence of the Secretary’s certification under Part L. However, now that the Part L certifications are satisfied, at least according to PhRMA, Part J, permitting otherwise illegal imports for personal use only, must be in effect.

When Congress passed this law, it recognized that Americans may not be able to afford prescription drugs domestically and should be able to buy them from another country. It set up a standard allowing consumers a fair degree of choice and told the FDA that the standard for its enforcement activity should be stopping an import that is an “unreasonable risk” to the individual. That risk is separate from risks to the “public’s health” from larger-scale, wholesale imports. If Congress wanted there to be “no additional risk” to individuals who import for their own use, then it could have said so.

The thing is that imports for personal use from licensed pharmacies in Canada and many other countries that require valid prescriptions are very safe, not to mention not an “unreasonable risk”. There’s a clear case to be made that Americans should feel emboldened to import prescription drugs for personal use now that Section 804 is in effect, at least according PhRMA!

For those who choose to import lower-cost prescription drugs, and order them online, make sure to stay safe by only ordering from credentialed international online pharmacies.

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[lonnysapotheek]

Human Rights Day: Safe and Affordable Imported Medicine and the Internet

Today is Human Rights Day, a day commemorating the United Nations’ 1948 adoption of the Universal Declaration of Human Rights (UDHR). Three years after World War II ended, in the wake of genocide, unprecedented military, deadly armed conflict, and mass deprivation on a global scale, the UN declared that all people in the world have rights that defend the dignity of humankind. Freedom of religion, speech, the right to assemble and own property, protection from discrimination or persecution are all central to human rights. Everyone has these rights “without distinction of any kind, such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status.”

These rights are applicable to Americans who can’t afford prescription drugs domestically because the prices are too high. Human rights include access to safe and affordable medicines, such as through importation of a more affordable drug ordered over the Internet.

In 2017, a group of activists, policy professionals, lawyers, and doctors came together in Brussels at the RightsCon conference to draft the Brussels Principles on the Sale of Medicines Over the Internet. Those principles were refined at RightsCon Toronto in 2018. The aspirational document supports the idea that principles of human rights should definitely apply to how we address access to medicine. Key parts of the document that apply include:

Recognizing that “The Internet has served as a disruptive force to traditional industry in the practice of pharmacy and trade in pharmaceutical products, allowing for the international sale of medical products to patients with a prescription.”

Affirming that in relation to the sale of medical products ordered for personal use over the Internet, “Access to affordable medical products is a fundamental component of the right to health”

How can we tie this to the UDHR? It states in Article 25:

“(1) Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care…”

Just three years ago, the UN Human Rights Council unequivocally declared that “Access to essential medicines is a fundamental element of the right to health”

Achieving universal access to essential medicines is also a part of the UN Sustainable Development Goals, SDG 3.8. Last year, I took the opportunity to respond to a request for public comments on this issue from the World Health Organization:

In support of SDG 3.8, the Internet, via international online pharmacies, has helped tens of millions of Americans obtain medicines from pharmacies in other countries.[v] In many of those cases, patients would otherwise not be able to obtain a prescribed medicine because price often determines access.[vi] In recognizing that price is an obstacle to access to medicines, Global Health Organizations can play a more constructive, forward-thinking role by promoting an open Internet through which regulated medicines can be purchased across borders both safely and at lower cost.

Let me put this into a concrete, real-world scenario. Let’s say a sick person in the U.S. can’t afford a prescription drug that they need to get better. They buy it online at a price they can afford, submitting a valid prescription from their doctor to a foreign licensed pharmacy, one that is lawfully permitted to ship it to that patient. It’s the exact same drug sold here. The prescription drug order import is refused and destroyed by the U.S. FDA because its label is not the one required for the sale of that drug in the U.S. The government has deprived that person of access to healthcare. Are their human rights being violated?  While most personal imports can be successfully received, the FDA does take away people’s prescription drugs as described.

See: FDA Destroys Elizabeth’s Personal Drug Import

As we honor human rights today and the Universal Declaration of Human Rights, our national and global health imperative is the distribution and administration of a vaccine to protect us all from Covid-19.

I’m dedicated to a future where we win the fight to make sure all people have the right to obtain the medicine they need to protect their health and save lives.  

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[lonnysapotheek]

Canada’s Order Against U.S. Drug Imports to Prevent Shortages Directed at Wholesale Not Patient Purchases

Canada issued an interim order on Friday, November 27, preventing drug establishments from exporting products that would risk causing domestic shortages. The press release with quotes from Health Minister Patty Hajdu may be more digestible than the official order.

As I see it, Americans who rely on buying less expensive prescription drugs from Canada should not be too concerned about this new development. The order is directed at companies who distribute drugs via wholesale channels, not pharmacies that dispense drugs directly to patients. Patients in the U.S. with a valid prescription who safely order drugs from pharmacies in Canada do so through licensed retail pharmacies not wholesalers.

The order was issued prior to the final rule in the U.S. allowing wholesale importation of lower cost drugs from Canada under what’s known as Section 804, which became effective November 30. States and other non-federal entities will need approval from the Secretary of Health and Human Services in order for any wholesale drug importation to commence under the new rule. Over the last year or so, Canada has expressed concerns about the Trump administration’s policies, fearing that larger scale wholesale drug importation from the U.S. could cause shortages. Canadian officials site the fact that the U.S. population is far larger. The U.S. has 329 million compared to Canada’s 38 million people. In any case, nothing has changed as of yet because Section 804 imports have not begun.

Drug shortages are a problem in many countries, Canada and the U.S. included. For information about drug shortages in the U.S. see: https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages; in Canada, see: https://www.drugshortagescanada.ca/.

The order states that a drug establishment may only distribute drugs for consumption outside of Canada if it “has reasonable grounds to believe that the distribution will not cause or exacerbate a shortage of the drug.” It also mandates new reporting requirements for those establishments that export drugs.

Canada has the right and obligation to protect its citizens from drug shortages. Its actions are understandable, if not commendable. However, Canada’s efforts do not mean that new initiatives on drug importation to lower prices in the U.S. will fail. It means that when wholesale importation commences through the new Section 804 channels, they must not cause shortages in Canada. It’s unknown at this time which specific products might be affected and the new order by Canada doesn’t mention any.

Licensed pharmacies in Canada that dispense prescription drugs to patients in the U.S. play an important role in helping Americans access treatments that are otherwise unaffordable. For the individual patients, that access is incredibly helpful, if not lifesaving. In the grand scheme of things, the personal drug importation market is too small to cause shortages in Canada. Furthermore, many “Canadian” online pharmacies partner with licensed pharmacies in other countries to fill prescription orders for Americans.

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[lonnysapotheek]

Millions of Americans Who Struggle with Drug Costs Are Also Hungry: Help Them This Thanksgiving

In Thanksgiving seasons past, I have written posts connecting the problems of high drug prices and hunger in America. Where people and households are struggling to afford food, there’s a greater likelihood that they are forgoing needed medical treatments, including prescription drugs. The problem is far worse for people with chronic medical conditions. This may seem intuitive and obvious, but for those wanting some academic research to chew on, take a look at this from The American Journal of Medicine:

“Treat or Eat: Food Insecurity, Cost-related Medication Underuse, and Unmet Needs.”

The research concludes: “Approximately 1 in 3 chronically ill NHIS participants are unable to afford food, medications, or both.” NHIS refers to the National Health Interview Survey.

Everything is worse this year. If you can help others who need it then you should.

Last year, a survey by Kaiser Family Foundation showed that about 25% of Americans say it’s difficult to afford their prescription drugs. That was before the pandemic. This Thanksgiving, in a disastrous second wave, America is witnessing the longest lines for food banks since the Great Depression. Reporting by National Geographic shows that 1 in 6 Americans could go hungry.  

Instead of pontificating with digs at Big Pharma or pointing to more depressing data, I’m going to ask that you Donate to Hunger Free America.

Hunger Free America “is a nonpartisan, national nonprofit organization building the movement to enact the policies and programs needed to end domestic hunger and ensure that all Americans have sufficient access to nutritious food.”

To you and yours, a Happy Thanksgiving

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[lonnysapotheek]

Amazon’s Pharmacy Doesn’t Break Big Pharma’s Hold of America’s Neck

Forgetting about the potential dangers to competition from corporate Leviathan Amazon, that it launched a new online pharmacy this week will certainly appeal to tens of millions of Americans. Prescription drugs are yet another thing you can get when you go to Amazon.com. And if you’re an Amazon Prime member (aren’t we all?), then there are discounts and whip-fast delivery to be had . But, unlike in many other industries where Amazon can crush the competition on prices, its online pharmacy launch does not accomplish that. Brand name drugs, ones without and even with generic competition, are similarly priced to other American pharmacies. PharmacyChecker checked this out and has some good advice for consumers about Amazon’s pharmacy at Ask PharmacyChecker this week.

Overall, brand name drugs do not appear to be any cheaper using Amazon Pharmacy than what you can get using a discount card found on GoodRx or PharmacyChecker. How can they when the pharmaceutical industry has monopolistic pricing power over patented drugs? Amazon is subject to the same average wholesale acquisition costs as Walgreens. Not only do drug manufacturers have patents: they have special international trade protections where companies cannot import these same drugs from foreign wholesalers who charge much lower prices in Canada, not to mention the even lower prices in the UK and European Union countries – unless the drug manufacturers do the importing or authorize it. 

Quick case in point. Insulin access activist Laura Marston, who has type 1 diabetes and needs insulin to live, tweeted that for insulin lispro, an authorized generic Amazon charges $137 a vial, only $4 savings. Why would I bring up a generic drug when my point above was about brand drugs? A vial or brand Humalog runs about $30 in Canada. That’s why people travel to and buy prescription drugs online from Canada and other countries. 

Now I’ve thought about Jeff Bezos and Amazon for a long time when it comes to this issue. I’ve also thought a lot about Senator Bernie Sanders’s outspoken stances against Big Pharma and Amazon. It led me to write an article last year that posed the question of what would happen if Bezos and Sanders teamed up to bring about comprehensive drug importation reform, opening up the U.S. market to lower drug price. Not surprisingly, the article is called “Jeff Bezos should team up with Bernie Sanders to offer lower drug prices to Americans.” 

Let me pivot to Walgreens for a minute. The full name of Walgreens is actually Walgreens Boots Alliance. Walgreens was founded in the U.S.; Boots in the UK. It is now a multinational pharmacy retailer and wholesaler, operating various businesses in 25 countries and with stores in 11 countries, according to its website. They sell the exact same prescription drugs at a Boots UK pharmacy for a fraction of the cost you’d find at your local Walgreens on main street, USA! Not cool. Not fair. See: The Walgreens UK Pharmacy Connection and Importation

For about 20 years now, Senator Sanders, first in the House, and then in the Senate, has been calling for safe drug importation, understanding that ending the prohibitions on drug importation that do not actually protect safety (just Pharma profits) will infuse competition to lower prices here. Jeff Bezos is the ultimate back breaker of traditional, entrenched and protected interests. He should relish the opportunity to do this. Amazon has the money and lobbying power to make it work! 

Our country is horribly divided right now. A Bezos-Bernie effort on drug prices could bring us together and finally break Big Pharma’s hold on our captive pharmaceutical marketplace. As it stands now, Amazon Pharmacy has not done so.

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