What does the data actually show about the safety of buying medication online? Is it really dangerous to buy lower cost medication from a pharmacy in another country over the Internet? Do drug companies fund research in this area?

This week, in our continuing quest to get the truth out and for our elected leaders in Congress to take bold action to protect online access to safe and affordable medication, we’re publishing the next section of our report called Online Pharmacies, Personal Drug Importation, and Public Health

Research and Data about Online Pharmacy Safety

 

There are only two peer-reviewed studies of foreign and domestic online pharmacies that test drug and online pharmacy safety by comparing those that are members of online pharmacy credentialing programs with others. Their combined findings are published by the B.E Journal of Economic Analysis and Policy in an article called “In Whom We Trust: The Role of Certification Agencies In Online Drug Markets” [“BEJEAP Study”]. Its lead author is Roger Bate, an economist and expert on counterfeit drugs with the American Enterprise Institute. The studies strongly indicate that credentialed international online pharmacies are equally as safe as domestic ones: the results showed that they only sell genuine medication, as well as require valid prescriptions.

In the BEJEAP study, through ‘mystery shopping’ – meaning posing as a consumer making actual purchases from domestic and international online pharmacies – and testing the prescription drugs ordered using a Raman Spectrometer, the authors found that all credentialed U.S. and international online pharmacies sell genuine and safe medication and require prescriptions. In contrast, some non-credentialed sites sent counterfeit drugs and/or did not require a prescription. The credentialing programs tested were those operated by NABP, LegitScript, PharmacyChecker.com and the Canadian International Pharmacy Association (CIPA). The study classified U.S. online pharmacies with approval by NABP and/or LegitScript as tier 1 sites (8 online pharmacies); non-U.S. online pharmacies with approval by PharmacyChecker.com and/or CIPA as tier 2 sites (22 online pharmacies, all approved by PharmacyChecker.com; 12 of the 22 approved by CIPA); and non-credentialed online pharmacies as tier 3 sites (49 online pharmacies).

Three hundred and seventy-eight orders of five medications were purchased from credentialed and non-credentialed online pharmacies. All medications ordered from credentialed online pharmacies, foreign and domestic, were genuine and dispensed pursuant to a valid prescription. Many orders from non-credentialed online pharmacies did not require a valid prescription; however, surprisingly, all products from non-credentialed sites were genuine, too, except Viagra, in which case 23% were not genuine and some contained dangerous ingredients.

The 22 international online pharmacies (tier 2 websites) shown to operate safely in the BEJEAP study – those verified by PharmacyChecker.com – are designated as “unapproved” by LegitScript and “rogue” by NABP.1 The authors of the BEJEAP study concluded: “If some foreign websites sell safe prescription drugs with substantial price discounts but American consumers are guided to buy from U.S. websites only, the FDA could potentially discourage price competition between U.S. and foreign pharmacies and therefore reduce drug affordability within the U.S.” A corollary conclusion is that by discouraging Americans never to use credentialed international online pharmacies, the FDA increases incidents of cost-related prescription non-adherence when U.S. pharmacy prices are the barrier to access.

The BEJEAP report’s data was not mentioned in the GAO report and its lead author, Mr. Bate, was not consulted, despite his well-known expertise in this area. Mr. Bate published a book on counterfeit and substandard pharmaceuticals called “Phake: The Deadly World of Falsified and Substandard Medicines”. He has consulted the FDA on drug safety, including directly with FDA Commissioner Margaret Hamburg and FDA is aware of Mr. Bate’s online pharmacy research.

The lead author of the GAO report participated with Mr. Bate in a series of expert panels organized by the Pew Charitable Trusts Drug Safety Project. Mr. Bate articulated his findings about online pharmacies for the Pew project, specifically noting that pharmacy websites approved by NABP and PharmacyChecker.com, including foreign pharmacies sent only genuine medications.

Unlike GAO’s recent report, the 2004 report by GAO also tested products and prescription requirements of online pharmacies. In “Internet Pharmacies: Some Pose Safety Risks for Consumers and are Unreliable in Their Business Practices,” the GAO found that Canadian online pharmacies all required a prescription, included proper pharmacy labeling and sold genuine medication. One of that report’s authors was Marcia Crosse.

In its 2013 report, the GAO appears to criticize state drug importation programs that, despite FDA warnings that “the agency could not ensure the safety of drugs not approved for sale in the United States,” contributed “to a perception among U.S. consumers that they can readily save money and obtain safe prescription drugs by purchasing them from Canada.” In this section the GAO seems to indicate that Americans are not able to obtain more affordable and safe medication from Canada when GAO’s own data from 2004, which was derived from mystery shopping and independent analysis, concludes that Americans can and do save money safely when purchasing medication online from Canada. Ironically, it’s reasonable to assume that state drug importation programs were pursued in earnest based on findings similar to those of the earlier GAO report or even the actual GAO report itself.

In contrast to the aforementioned peer-reviewed studies and the earlier GAO report, other studies about purchasing medication from online pharmacies focus only on rogue websites, such as those selling prescription drugs without requiring valid prescriptions and/or that don’t publish contact information. Not surprisingly, such studies conclude that rogue online pharmacies are dangerous. Those studies may help to understand and demonstrate the dangers presented by Internet drug sales, but do not help in determining which online pharmacies are safe and a clear benefit to consumers.

One such study is called “Internet-Ordered Viagra (Sildenafil Citrate) Is Rarely Genuine.” The study is financed and conducted by drug company Pfizer. None of the websites Pfizer assessed required consumers to submit a valid prescription based on a physical exam (but two did require online or “remote” consultations, which is legal in some states). Not surprisingly, the prescription requirement assessment concluded that no websites required a valid prescription, meaning based on a physical exam. The costs per pill were between $3.28 and $33.00. The products were shipped from Hong Kong (11 sites), United States (6 sites), United Kingdom (2 sites), Canada (1 site), China (1 site), and India (1 site). Seventy-seven percent of the products received were counterfeit; 18% authentic; 5% foreign generics (generic version approved in another country) that are not approved in the U.S.

The Pfizer study concludes “Internet sites claiming to sell authentic Viagra shipped counterfeit medication 77% of the time; counterfeits usually came from non-U.S. addresses and had 30%-50% of the labeled API [active pharmaceutical ingredients] claim. Caution is warranted when purchasing Viagra via the Internet.” While most of these sites were foreign-based, none were credentialed or required a prescription based on an in-person consultation with a licensed prescriber. The incidence of counterfeits received in Pfizer’s study appears very high, even compared to other studies that procure medications from non-credentialed online pharmacies. This research, and other studies like it, shows there are many rogue online pharmacies that sell counterfeit Viagra, but it does not negate the existence of safe international online pharmacies.


1 I know this because all 22 tier 2 sites were approved by PharmacyChecker.com during the mystery shopping of the researchers, and NABP routinely adds PharmacyChecker.com-approved online pharmacies to its Not Recommended list, as does LegitScript to its Unapproved List.
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Americans have been ordering medication over the Internet from foreign pharmacies for about 15 years. How many reported deaths or serious adverse reactions would you guess have been associated with purchases from international online pharmacies that require a prescription? Zero. Sadly, rogue online pharmacies, domestic and foreign, have contributed to injury and even death.

This week, in our continuing quest to get the truth out and for our elected leaders in Congress to take bold action to protect online access to safe and affordable medication, we’re publishing the next section of our report called Online Pharmacies, Personal Drug Importation, and Public Health(more…)

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Continuing our quest to get the truth out and for our elected leaders in Congress to take bold action to protect online access to safe and affordable medication, we’re publishing a section a week of our report called Online Pharmacies, Personal Drug Importation, and Public Health. This week we look at the reasons why Americans look online to buy medication:

High U.S. drug prices are one of the main reasons that Americans go online to buy medication. As stated previously, according to the CDC, about five million Americans buy medication internationally each year due to high domestic drug prices. The CDC’s figures and others identified below show that over the past 15 years, tens of millions of Americans have purchased medication from outside the U.S. using online pharmacies to save money or because they could not afford the prices at their local pharmacies. Fifty million Americans between the ages of 18 to 64 did not fill a prescription in 2012 due to cost, up from 29 million in 2001. The data demonstrates that Americans need international online pharmacies due to a public health crisis of high domestic drug prices.

There are other reasons Americans go online to buy medication besides cost. Online pharmacies offer convenience and anonymity. For some consumers with mobility problems or for those who live in rural locations, ordering online and receiving medication by mail can be very helpful. Others may feel embarrassed about their medical conditions, which are sometimes unintentionally disclosed at their local pharmacy counters, preferring to order privately online.

Unfortunately, some Americans go online seeking medication without first obtaining a prescription from their healthcare providers. Many such people should not be judged. Americans who are uninsured may be unable to afford the medical care necessary to get a prescription and shop from online pharmacies that do not require one. Others just don’t want the “hassle” of going to the doctor and getting a prescription. There are obvious and inherent dangers in taking certain medications without first consulting with a licensed prescriber. Additionally, online pharmacies, foreign and domestic, that do not require a prescription are more likely to sell falsified and substandard medication and not ship medication safely.

Growing numbers of insured Americans in the coming years, a result of the Patient Protection and Affordable Care Act, will lead to a decline in medications ordered online without a prescription. However, many newly insured will find that their prescribed medications are not covered by their plans and are too expensive to pay for out-of-pocket at a U.S. pharmacy. For some, international online pharmacies are the only route to obtaining needed medication.

Finally, some Americans looking to obtain prescription narcotics without a prescription turn to the Internet, but the prevalence of such purchases are a small part of America’s prescription abuse problem. Still, the most serious negative health consequences related to prescription drugs bought over the Internet are from controlled drugs purchased without a valid prescription. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which largely banned online prescribing for controlled substances, was named after 18 year-old Ryan Haight who purchased prescription narcotics from an online pharmacy based in Oklahoma without a valid prescription and died from an overdose.

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When a Canadian Online Pharmacy Isn’t Just Canadian

An article by Joe Rothstein in EIN News concerning personal drug importation and online pharmacies recently caught our eye for two reasons. First, Mr. Rothstein called out the pharmaceutical industry for funding groups that give poor advice to consumers about buying medication online. Second, Mr. Rothstein identified PharmacyChecker.com as a source for “providing a list of certified Canadian suppliers who sell at prices usually well below the cost of U.S. pharmacies.” It is true that we do that, but our efforts extend far beyond Canada; we also verify and inspect pharmacies in many other countries, which was not mentioned in the article.

So what’s the issue? Remember, that according to the FDA, personally importing medication under most circumstances is technically illegal. Of course, many of us believe that it can be and is done very safely. Mr. Rothstein’s article states “…defenders of the importation law argue that thousands of phony online sites claim to be ‘Canadian’ to fool the unwary, and for self-protection consumers should avoid Canadian sites entirely.” Opponents of personal drug importation use those quotes around Canadian because they believe that dangerous rogue online pharmacies deceive consumers by claiming to be Canadian, only to ship medication from another country. On this count we agree with Big Pharma, however there are also safe Canadian online pharmacies that do refer prescription orders to licensed pharmacies in other countries.

PharmacyChecker.com verifies companies like this, making sure that every pharmacy a medication is shipped from is licensed and requires valid prescriptions.

Today, international online pharmacy takes place in a global marketplace. Yes, the history of Americans importing drugs for personal use begins with Canada (and even Mexico), when in a pre-Internet age Americans would cross the border to buy cheap meds. Then a crop of Canadian pharmacies began to operate online. In 2004, we began verifying pharmacies in several other countries that filled order for online Canadian pharmacies in our program. Canadian pharmacies were going global in part because drug companies actually cut supplies to pharmacies based in Canada that mailed prescription drugs to Americans, and also to offer medication from countries with lower prices than Canada.

So what’s the difference between a rogue “Canadian” online pharmacy and a verified Canadian pharmacy website when they both ship from pharmacies outside Canada? The rogue pharmacy has a much higher chance of causing you harm, especially if it doesn’t require a prescription, doesn’t send meds from licensed pharmacies, or lies about where your medication comes from. There’s no accountability. When ordering from PharmacyChecker-verified Canadian online pharmacies, you will be given the choice where your meds come from, you will know your medication is coming from a licensed pharmacy, and you will have to have a valid prescription.

PharmacyChecker.com verifies pharmacies in Australia, Barbados, Canada, India, Mauritius, New Zealand, Turkey, U.S., U.K, and Singapore. Pharmacies in Barbados, India, Mauritius, and Singapore undergo a rigorous inspection for safety and drug quality. You can read about our standards. Keep in mind, the medications at your local U.S. pharmacy come from literally dozens of countries, with most generics coming from India.

We contacted Mr. Rothstein to let him know that the Canadian online pharmacy industry is global to help him in his future coverage of issues relating to prescription drug importation, online pharmacies and affordability. We want you to find the safest medication at a price you can afford, but we also want you to know where it’s coming from. The PharmacyChecker.com seal on a website will let you know that you are working with a real pharmacy, no matter where your meds come from.

 

 

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On February 12th of this year, we sent a comprehensive report about buying medication online to the Senate Committee on Health, Education, Labor and Pensions and House Committee on Energy and Commerce. Our purpose was to correct the public record by challenging a flawed report about Internet pharmacies written by the Government Accountability Office (GAO) back in 2013. The GAO’s report essentially parroted the narrative that the pharmaceutical companies, U.S. pharmacies, and FDA want you to hear, which ignores the existence of safe international online pharmacies that help Americans afford safe medication. Due to the incredible importance of this issue, we are publishing a section of our report each week. For the full report, click Online Pharmacies, Personal Drug Importation and the Public Health.

This week you can read a “History of Online Pharmacies.” It’s not a comprehensive history but gives the reader enough background to digest the larger issues contained in the report. When you think about, online pharmacies are really “mail order pharmacies” with websites. Did you know that mail order pharmacy has been around for well over a hundred years?

The Internet has facilitated a major proliferation of mail-order pharmacy operations. Mail-order pharmacies are not new; they have served Americans since the late 1800s. Internet pharmacies, often referred to as “online pharmacies,” can be defined as websites that market and sell prescription medication over the Internet that is dispensed by mail-order. When they began operating in the mid to late 1990s, online pharmacies quickly became a subject of concern for federal regulators and Congress due to dangerous and illicit practices. The NABP created the Verified Internet Pharmacy Practice Sites (VIPPS) in 1999, a voluntary program open to domestic pharmacies to help consumers identify safe online pharmacies.

Drugstore.com, which launched its website in 1999, was considered a first-mover in the industry and an example of a safe online pharmacy without a bricks-and-mortar presence. It required a valid prescription and dispensed medication from a licensed pharmacy. By the beginning of the last decade, most major chain pharmacies were doing business online by taking new and refill prescription orders, and mailing them across the country. Drugstore.com and most but not all online pharmacies associated with major chain pharmacies and Pharmacy Benefit Management (PBM) companies became VIPPS-approved by 2003.

Around 2000, Canadian pharmacies began online marketing to reach American consumers, which provided Americans with access to low-priced drugs. Previously, personal drug importation from Canada was relegated to those living on border-states. This issue also gained public attention through media coverage of bus trips, which brought seniors up to Canada to buy medication and were sometimes sponsored by U.S. politicians supportive of reforming drug importation laws. Canadian pharmacies later began partnering with licensed pharmacies in other countries, such as Australia, New Zealand, and the UK, and later India and Turkey, as well as those in free trade zones. They did so in part to evade supply restrictions imposed by pharmaceutical companies against Canadian pharmacies, but also to take advantage of even lower drug prices found elsewhere and to increase profits.

In 2002, PharmacyChecker.com began operations to verify both U.S. and foreign online pharmacies – as well as to compare drug prices for consumers seeking the lowest prices for their medications. CIPA was founded that same year. CIPA’s vice president testified at a congressional hearing in 2003 entitled: “International Prescription Drug Parity: Are Americans Being Protected or Gouged?” In 2004, the FDA recognized PharmacyChecker.com’s efforts to help consumers find the lowest prices and directed people to www.pharmacychecker.com as part of media relations efforts to show that U.S. generic drug prices are lower in the U.S. than in Canada.

While the Internet has enabled millions of Americans to find safe and lower cost medication from outside the U.S., it has also created a public health minefield where dangerous websites posing as safe pharmacies, U.S. and foreign, are accessed every day. Such websites sell fake, adulterated and/or low quality medication, or genuine and safe prescription drugs but without requiring a prescription. These rogue online pharmacies are a serious threat to patient safety and have caused sickness and death.

While too many Americans today have online access to and buy from rogue foreign pharmacies, many are benefiting from safe foreign pharmacies. Americans, including elected officials and public health regulators, know that low-priced and safe prescription medication can be found online internationally. For instance, former Health and Human Services Secretary Kathleen Sebelius adopted a personal drug importation program when she was Governor of Kansas that allowed consumers to find international pharmacies over the Internet. The State of Maine recently updated its pharmacy licensure requirements to permit sales from pharmacies that are licensed in Australia, Canada, New Zealand and the United Kingdom, in effect abolishing state restrictions on personal drug imports from those countries.

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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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