Unfortunately, a Maine state law that was created to help people access lower cost medication from licensed pharmacies in Australia, Canada, New Zealand and the United Kingdom, was invalidated yesterday in a decision by federal court Judge Nancy Torresen. Basically the judge, invoking a legal doctrine called “preemption,” concluded that federal law beats state law when it comes to foreign commerce, and since federal law technically bans personal drug importation under most circumstances, Maine’s law is trumped. I’ll return at the end to deal with a little legalese fun (but not too much!).

Taking a walk down memory lane here: personal drug importation programs in Maine, such as one operated for the City of Portland, Portland Meds since 2004, which has helped Americans save many millions of dollars, were shut down in 2012 by former State Attorney General William Schneider. The programs were shut down because Maine’s pharmacy groups persuaded AG Schneider that Canadian and all foreign pharmacies should be stopped from mail order pharmacy sales into Maine because they are not licensed in Maine. Most U.S. states require pharmacies based elsewhere to obtain an out-of-state pharmacy license if they want to sell medication by mail to their residents. While there are exceptions, most states do not allow pharmacies in other countries to obtain an out-of-state license.

Maine legislators were angered by this action and passed a law, LD 171 “An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies,” that exempted licensed pharmacies in Australia, Canada, New Zealand, and the UK from having to obtain an out-of-state Maine pharmacy license. Not only was this law passed on a bi-partisan basis but the vote was overwhelming: Maine’s House voted 107-37: the Senate voted 30-4. And with that the personal drug importation programs resumed.

The law was invalidated, now what?

Programs like Portland Meds will not necessarily shutdown. We’ll have to wait and see what happens. But if they do shutdown then thousands of Mainers will be paying more for their medications. More seriously, some Mainers will likely end up skipping their medications because the prices at their local pharmacies are too high for them. Back in 2012, an owner of one company that worked with CanaRx, a Canadian pharmacy benefit company, admitted that by working with licensed foreign pharmacies his company saved money: but there was more to the story than simply a company saving money. Quoting a journalist from the Bangor Daily News:

While acknowledging that Hardwood Products “as a company is trying to save money,” Young said his greatest fear is that a spike in costs will spur his employees to stop taking medications for conditions such as diabetes and asthma.

“We have many people here who are hourly employees,” he said. “We pay a fair wage, but the impact out of the family net income will be significant. More important than the money is the health and well being of the employees and their families. What dollar figure do you put on that?”

…but all hope is not even close to lost! Americans still have access to safe and more affordable medication available online, and, again, Maine’s programs have not yet shut down. Equally as important to the longer term cause of prescription justice, the ruling leaves the door open for the State of Maine to appeal the decision up the legal food chain to the 1st Circuit Court of Appeals in Boston. If Maine wins then other states may follow its lead by passing similar legislation to promote access to lower costs medications from other countries.

I’m pretty certain that, with the requisite political will from Maine’s legislators, citizen rabblerousing, and some good legal marksmanship, there are ways to overcome and defeat Judge Torresen’s ruling.

To conclude, I’d like to challenge something Judge Torresen opined in her ruling to nullify Maine’s foreign pharmacy law:

“Congress enacted the FDCA [Food, Drug and Cosmetics Act] to bolster consumer protection against harmful products.”…In furtherance of this purpose, Congress has created a complex regulatory scheme covering the importation of pharmaceuticals into the United States…

Is that so? Maybe…in part. However, I believe that banning Americans from importing lower cost and safe prescription medication from licensed pharmacies for their own use does nothing to bolster consumer protection against harmful products but quite a lot to bolster protection of big drug company and U.S. chain pharmacy profits. I know that the ban impedes Americans from taking medications they need and forces more financial hardship. Are these facts that could hold up in court? I think so.

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Correcting the Public Record about Online Pharmacies and Personal Drug Importation

Correcting the Public Record about Online Pharmacies and Personal Drug Importation

In July of the 2013, the Government Accountability Office (GAO) published a report about Internet Pharmacies with a focus on foreign websites that I believe strongly distorted the public record about buying medication online through personal drug importation. GAO’s report was submitted to Congress in response to Section 1127 of the Food and Drug Administration Safety and Innovation Act, intended to protect the public health. I wrote a report to refute the GAO’s positions in order to correct the public record regarding the intersection of online pharmacies, personal drug importation, drug affordability and the public health. I believe that my report about online pharmacies proves that the GAO’s efforts fell very short in getting to the truth about buying medication online.

Americans buy lower cost and safe medication internationally, often online, and it benefits their health and financial well-being. If it were not for the option of personally importing lower cost medication, often using the Internet, many Americans would just not be able to get medical treatments they need. People who can’t take needed medication often get sick and may even die.  The GAO report did not mention these facts.

The GAO seemed to conflate safe international online pharmacies with rogue online pharmacies in the same manner we’ve come to expect from the pharmaceutical industry, U.S. pharmacy trade associations and the FDA – by calling safe international online pharmacies “rogue.” The problem, for me, is that its lead author is not with the pharmaceutical industry, a U.S. pharmacy trade association, or the FDA. She is someone I’ve come to admire over the years just by following her work with GAO. So I can’t just say “look, it’s big Pharma again!” So for almost a year and a half I’ve written a report to, in part, prove to and remind myself that “we’re right and they’re wrong.” I’ve done that. I look forward to this report becoming a part of the public record.

Rogue online pharmacies, meaning drug-selling websites that are not safe (see my report for details), should be shutdown. Let’s get rid of them! However, if our elected leaders and regulators allow or enact policies to bring about an end to online access by Americans to safe and affordable medication and people get hurt, then they can’t say they didn’t know.

Below, I’ve pasted the cover letter from Tod Cooperman, MD, president of PharmacyChecker.com, and I that accompanied the hardcopy of the report we sent the congressional committees that received the GAO’s report in 2013. Each week we’ll be commenting on and posting the different sections of my report. To read the report now, visit “Online Pharmacies, Personal Drug Importation and Public Health”.

(more…)

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Low Cost Counterfeit Drugs Save Lives in China…What?!

I wish I was joking about the racy headline above. The United States is not the only great power in which citizens go without medication because of cost. The cancer drug Gleevec (imatinib), made by Novartis, costs 23,500 yuan, or about U.S. $3,783, per month, in China. Gleevec is not covered by health insurance in China so people there must pay for it out of pocket. Ten years ago, Lu Yong was diagnosed with chronic myelocytic leukemia and was prescribed Gleevec. After facing bankruptcy due to his drug costs, Lu discovered a generic version of Gleevec, called Veenat, and began purchasing it by mail-order from India where it is an approved drug, at a cost of only 3,000 yuan, or about $482, per month — 87% less than the brand name drug.

Lu’s condition improved quickly using  the generic version. He began to help people with leukemia who he met online obtain Veenat. Now, according to the English edition of Caixin, an independent Beijing-based media outlet, he is facing criminal charges for credit card fraud and selling counterfeit medication. The same story was covered by official Chinese media under the headline “Leukemia patient prosecuted for buying pills overseas.” Lu has helped 1,000 people with leukemia obtain treatment. Three hundred of them are petitioning the authorities to have his name cleared.

The medications involved are real and clearly life-saving! So why is Lu being prosecuted for counterfeit drugs? Under Chinese law, any drug not specifically licensed for sale in China, even a genuine medication lawfully manufactured by an authorized drug company, is considered counterfeit.

The charge of credit card fraud was based on Lu’s using a foreign credit card to make the purchases. Lu said he did so because using domestic Chinese bank-issued credit cards for international purchases is nearly impossible.

Lu was not charged for procuring his own cancer medication. The charges were for directly facilitating the purchase of the drug for 1000 people, who consequently regard Lu as a hero.

When people can’t afford to obtain life-saving medication locally, the U.S, and all countries, should consider themselves morally obligated to expressly permit their citizens to obtain it internationally.

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The fight for access to safe and affordable medication will continue in 2015. As 2014 ends we find the price of medication continuing to escalate. AARP’s recent drug price report showed that brand name drug prices had increased by 13% in 2013, eight times the rate of inflation. The costs of generic drugs are going through the roof, some by astronomical amounts – to the tune of thousands of percent. Then of course 2014 brought us Sovaldi at $1000/pill, which is just the tip of the iceberg, as many more outrageously priced “specialty medications” are coming down the pipeline in 2015. New drugs that save lives and help people get better are great…but only if they are affordable.

In the holiday spirit, Senator Amy Klobuchar from Minnesota published a Christmas-themed op-ed last week called “How the Drug Companies Play Scrooge,” as in Ebenezer Scrooge, the greedy miser in Charles Dickens’ famous story A Christmas Carol. Klobuchar’s ghosts of Christmas past, present and future are, respectively, rampant drug price increases; the highest drug prices in the world by far; and the continuing assault on the pocketbooks of Americans by pharmaceutical companies unless Congress acts. Interestingly, Sen. Klobuchar’s metaphor compares Scrooge to Congress (not the pharmaceutical industry). She writes: “if Ebenezer Scrooge can be transformed from a crotchety, thoughtless, “bah humbug” miser to a generous steward of good will to all after only one night of ghostly visits, certainly there is hope for Congress.”

What can Congress do to end its Scrooge-like protection of big pharma?  Sen. Klobuchar recommends three legislative solutions. Congress should pass legislation that would allow Medicare to negotiate drug prices with pharmaceutical companies under the same protocols permitted to the Department of Veterans Affairs. Currently, federal law actually bans such negotiations. Under one estimate, due to the VA’s ability to negotiate prices, drug prices are 40% lower when obtained through the VA than through Medicare.

Ending what Sen. Klobuchar calls “illegal pay-to-delay” deals between brand name and generic pharmaceutical companies, which postpone market availability of lower cost generic drugs, is another solution that can be addressed legislatively. Legislation introduced by Klobuchar and Sen. Charles Grassley would give the Federal Trade Commission more authority to stop those deals. Sen. Klobuchar asserts that the savings from ending pay-to-delay could be $4.7 billion for the U.S. budget and $3.5 billion for consumers.

Last but not least, Sen. Klobuchar recommends helping American consumers to personally import lower cost medication by passing The Safe and Affordable Drugs from Canada Act. This legislation, co-sponsored by Sen. John McCain from Arizona, would essentially codify the current practice of Americans buying lower cost medication from Canadian pharmacies.  We support this bill but believe it needs to be expanded to include pharmacies in many other countries from which lower cost and safe medication can be and currently are obtained.

Congressional opponents of Klobuchar’s personal drug importation bill, the most vociferous among them surely raking in huge donations from big pharmaceutical companies, will argue that the Act will open the door to counterfeit drugs and rogue online pharmacies.  The fact that counterfeit drugs and rogue online pharmacies exist, however, is not an argument against facilitating safe personal drug importation from verified international online pharmacies. Five million Americans already import medication for their own use.  Consumers who purchase from safe international online pharmacies, such as those in the PharmacyChecker.com Verification Program, are able to save thousands of dollars a year.  For many, personal importation of lower cost medication is the only option for obtaining needed prescription drugs.

While the FDA doesn’t prosecute Americans who import medications for their own use, federal law still holds that, under most circumstances, it is a crime!! It’s understandable that prescription drug importation meant for re-sale in U.S. pharmacies is regulated to that extent that those who violate the laws are subject to penalties.  In contrast, people who need to import medication for their own use because they can’t afford the prices at U.S. pharmacies should not be subject to criminal enforcement of any kind, ever. So I hope that Senator Klobuchar and her colleagues, in addition to her recommendations identified above, introduce and pass a bill to amend federal law to decriminalize personal drug importation.  By doing so Congress would bring prescription justice to Americans who are haunted by the scary ghosts, past, present and future, of the pharmaceutical industry.

Happy Holidays and New Year from PharmacyChecker.com!!

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From Pembroke Consulting, published on DrugChannels.net

From Pembroke Consulting, published on DrugChannels.net

Yesterday, Senator Bernie Sanders (I-VT) held a hearing in front of the Senate Health, Education, Labor and Pensions Subcommittee on Primary Aging and Health entitled “Why Are Some Generic Drugs Skyrocketing in Price?” Bizarre drug price increases of 1,000% and up are becoming more common. This problem is not new: in the beginning of this year the People’s Pharmacy reported a 6,000% increase in the price Doxycycline!

Senator Sanders noted that the price of Digoxin, which treats congestive heart failure, has increased 883% from 12 cents to $1.06 per pill from 2013 to 2014. Migraine drug Divalproex Sodium ER spiked 881% from 27 cents to $2.38 per pill.

We are always ecstatic when Congress scrutinizes the obscene drug prices in America, and we applaud Sen. Sanders, but our focus is on what can be done now so that people today don’t go without needed medications. In his introductory remarks, Sen. Sanders said: “Drug prices in the country are by far the highest in the world.” Let’s elaborate on that. (more…)

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The opinions and research of two Americans, published this week in local newspapers, epitomize the position of millions of Americans: drug prices are too high and safe personal drug importation is a smart way to afford medication. Tom Kennedy compared prices between the U.S. and Canada in 2003, and he is doing it again 11 years later. His guest opinion in the Billings Gazette has shown that U.S. prices have increased 153% for the drugs he tracked since 2003, far outpacing the rise in income and cost of living. He has some good economic insight and analysis, and I recommend reading his whole opinion, which you can find here.

David Di Saia, from North Providence, Rhode Island, found that he could save $480 a year by using a Canadian pharmacy instead of the pharmacy associated with his Medicare plan. And that’s just the savings for one medication! Imagine the savings if he had to order more than one drug. You can read his story, which is “sad, but true” on the Valley Breeze website.

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Fight the Tyranny of High Prescription Drug Prices this 4th of July

U.S. flag and pillAs we approach July 4th, a day to celebrate freedom in America, I urge you to stand up for your freedom to access safe and affordable medication!! Let’s face it: the global drug companies – big Pharma – would rather you pay higher prices for their medications because it makes them more money. In its infinite pandering to big Pharma, Congress included language in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) – an otherwise pretty useful drug safety bill – expanding the authority of the U.S. Food and Drug Administration to destroy safe, personally imported medications. In the spirit of independence – life, liberty, and the pursuit of happiness – take this time to send a message to the Secretary of the Department of Health and Human Services (HHS) asking that she take the necessary actions to protect your prescription drug orders, ones ordered from safe international online pharmacies.

Thanks to RxRights.org for leading the charge on this effort!

The onerous language under discussion is found in Section 708 of FDASIA, which allows the FDA to destroy medication orders valued at $2500 or less that are refused import. The medications subject to refusal and destruction are those deemed “adulterated, misbranded or counterfeit.” Those words seem pretty scary but don’t be fooled. Unlike an adulterated or counterfeit drug, an imported ‘misbranded’ drug can be the same, safe and effective medication sold in a U.S. pharmacy but with a slightly different label.  Seizing and destroying a person’s safe prescription drug order is immoral, anti-American, and dangerous to that person’s health.

There’s a catch in the law, which actually invokes the Spirit of 1776. Before Section 708 goes into effect, the HHS Secretary shall draft proposed regulations to provide consumers with due process to “challenge the decision to destroy the drug.” That means Americans should have an opportunity when their medication orders are seized to tell the government “don’t destroy my safe prescription drug order.”  As the agency under HHS tasked with regulating the nation’s drug supply, it’s the FDA that leads the government in this process. FDA’s proposed regulations, which are open for public comment, were drafted and published in early May.  While they fail to provide what the law requires – “appropriate due process” – I believe they leave the door open to amend what they have proposed. This weekend I’ll be working to submit PharmacyChecker.com’s public comments to try and assist (persuade?) the FDA to issue a more consumer-friendly final regulation that protects your access to safe and affordable imported medication.

I invoke the spirits of our Founding Fathers to guide us in this fight for independence from the tyranny of high drug prices.

Happy Fourth of July!

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A couple of news articles from the state of Maine have me wondering if more Mainers are going to start importing medication from international online pharmacies. Maine is the only state that has, through the passage of a law, removed state restrictions on personal drug importation from pharmacies in a number of countries.

An article from the Sun Journal highlights a survey designed to track the impact of the Affordable Care Act in Maine (and perhaps these findings will apply to other states, too). Both low and middle-income Maine adults are struggling with medical bills. Surprisingly, 35% of middle-income adults had problems paying bills, compared to 32% of low-income adults. Budget cuts in the state have led to thousands of residents losing Medicaid coverage, so it is likely that the numbers will worsen for low-income adults.

Speaking of budget cuts, Maine Governor Paul LePage did not choose to expand another state program, Mainecare, which helps low-income residents pay healthcare providers. Samantha Edwards, writing for WLBZ, notes that residents who were in these programs are now looking elsewhere for assistance, especially for prescription drugs. The cuts to state programs are forcing municipalities to cover the costs. Rindy Folger, of Bangor Health and Community Services, said, “Since January 1st, we have seen over seventy-five people who we have never seen before who are now coming in looking for help with their medications…Monthly right now we are paying about $9,500 in prescriptions which, over the course of the year, is a significant amount of money for the Bangor taxpayers to have to pay.”

If municipalities like Bangor are going to be picking up the tab for medication, it might be wise for them (or the state) to implement prescription drug importation programs. Portland saved $200,000 a year on health care when it served prescriptions to its employees through PortlandMeds, a prescription drug importation program. It’s very possible – and reasonable – that more municipalities will implement these programs if the Maine’s healthcare cuts continue.

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This article summarizes good things and bad that are happening online with drug prices and savings, economics, legislation, politics, and even ethics that relate to access by Americans to more affordable medication offered by safe international online pharmacies. If you’re a consumer – especially an American consumer facing high drug costs – you should read this. When you’re done (or even right now!) we recommend joining RxRights to help play a role in making medication more affordable for all Americans.

Next year, we’re planning to focus more attention on local Americans pharmacies: what they’re doing right, wrong, and in between, and how you can save and take advantage of their in-store opportunities to improve your health! But for now, the international online pharmacy report…

The Good

The money Americans could save on brand name drugs by shopping at safe international online pharmacies continued to increase in 2013. In 2011 , we reported potential savings of 80%, then a mind-boggling 85% in 2012, and now 87.6% in 2013! Savings have proliferated because America’s trading partners, such as Australia, Canada, the states of the European Union, New Zealand, the United Kingdom, and Turkey, generally, have kept brand drug prices stable, whereas in America they increased by an estimated 13% last year.

The pricing data referred to above is from our prescription drug price savings research released this past September. In that report we looked at popular prescription drugs that are not always covered by health insurance plans, including new plans offered as a result of Obamacare. An extreme example of savings is on the drug Abilify 10 mg, a medication prescribed for depression; $9,007.08 could be saved annually by purchasing the drug from the lowest-cost online pharmacy verified by PharmacyChecker.com compared with a retail pharmacy in New York City.  A more common example of potential annual savings from international pharmacies is the $3,935.28 savings on Spiriva Handihaler 18 mcg. Drug prices are out of control in the U.S., especially for those with no domestic generic alternative, and access to international online pharmacies is as urgent as ever.

It would, of course, be better if Americans could find more reasonable prices on brand name drugs at their local pharmacies.

(more…)

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For 15 weeks, we tracked prices among U.S. and foreign pharmacies on popular drugs manufactured in in the U.S. (including Puerto Rico). Our analysis found that these medications were an average 76% less expensive from the lowest-cost PharmacyChecker.com-approved international pharmacy than a local U.S. pharmacy in New York City. Even when medications were available as generics, such as Singluair and Urocit-K, the prices for the brand name abroad were cheaper than the generic in the U.S.

Just for the record, prescription drugs manufactured under government regulation in many other countries are just as safe as those made here. Critics of international online pharmacies (mostly people connected to drug companies or big chain pharmacy interests) often mention poor foreign manufacturing practices, especially for generic drugs, outside the U.S. to scare Americans from ordering medication internationally.  But so many FDA-approved drugs currently sold in U.S. pharmacies are imported – 40% according to the FDA – and many are generics. As our vice president Gabriel Levitt said, “We looked only at brand name medications manufactured in the U.S., not because they’re any safer than those made elsewhere, but because we found it so compelling that the same drugs made here are about 76% less expensive abroad.”

For more information, read our recent press release.

Average Savings Buying from an International Online Pharmacy for Brand Name Medications Manufactured in America*

 

Drug Local U.S. Pharmacy Price Lowest International PharmacyChecker.com Listed Price Percent Savings
Acuvail 0.45% – 30 vials+ $249 $65 74%
Cardura XL 4 mg – 90 pills $285 $67 76%
Crestor 40 mg – 90 pills+ $680 $140 79%
Cymbalta 60 mg – 90 pills+ $879 $116 87%
Invega 6 mg – 90 pills $1,932 $580 70%
Janumet 50/500 mg – 180 pills+ $1,050 $172 84%
Lotemax 0.5% – 5 ml $188 $30 84%
Lumigan 0.03% – 2.5 ml $114 $22 81%
Pataday 0.2% – 2.5 ml $161 $34 79%
Pulmicort 0.25 mg/2ml – 60 respules $698 $117 83%
Restasis 0.05% – 60 Vials $394 $116 71%
Singulair Granules 4 mg – 90 pills+ $732 $176 76%
Strattera 25 mg – 90 caps+ $828 $311 63%
Tarceva 100 mg – 30 pills $6,531 $1,949 70%
Urocit-K 10 meq – 90 pills++ $146 $57 61%
Average Savings 76%
* Includes manufacturing in Puerto Rico, Local U.S. Pharmacy Prices found at a New York City Rite-Aid
+price calculated from 84 pills.
++price calculated from 100 pills.
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