In online pharmacy news, the major story today is that FedEx was indicted for distributing controlled prescription drugs for Internet pharmacies to people who did not have valid prescriptions. FedEx claims it is not guilty and that its indictment and potential prosecution threaten a key principle of its business ethics and federal law: don’t open the mail. FedEx also says that for years they have asked the DEA for a list of targeted illegal online pharmacies but have not received one and that it cannot be expected to act as a law enforcement agency. The U.S. Department of Justice alleges that FedEx specifically “conspired” with two online pharmacies selling controlled drugs without proper prescriptions.

I’m departing from this media hot topic (better you read it in Bloomberg, USA Today, etc) to give you some backstory on controlled drugs and Internet sales. Our blog’s usual focus is on consumers seeking non-controlled prescription drugs online, and the PharmacyChecker.com Verification bans online pharmacies that sell controlled without a valid prescription, and all international online pharmacies that sell controlled drugs into the U.S. However, some Americans try to obtain prescription narcotics and other controlled drugs without a prescription online, which can turn out deadly. (more…)

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In our recent public comments to the U.S. Food and Drug administration, we invoked your concerns with new FDA regulations to implement Section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA) for destroying safe (and affordable) medications imported for personal use. We issued a press release on the issue as well. Here are three of almost 2000 comments:

Morton Ross, Palm Harbor, FL 2014-04-03, “The Meds I take daily, are the difference between ‘Life and Death’. I cannot afford the higher prices at local pharmacies.”

Darilyn Schlie, Fort Worth, TX 2014-04-03, “Without the ability to go outside the US, I will not be able to afford the medication I need.”

James Marshall, Nashville, TN 2014-04-03, “I have emphysema and could not afford my medications if not for being able to order some of them from outside the USA.”

We need more voices! Working with RxRights.org, you can send a message to the Secretary of Health and Human Services stating your concerns, asking that she prevent morally unjust and dangerous refusals and destructions of imported drugs for personal use. The messaging process is easy and together we can win this!

The situation is not dire…yet. The regulation has not taken effect and it’s uncertain what its impact will actually be. Currently, the conventional wisdom holds that the chances of your prescription order being detained by U.S. Customs is less than 1%. What we don’t know is if the new regulations will change that dramatically.

What we do know is that FDA issued a proposed rule in May to implement Section 708, which is deceptively called “Destruction of Adulterated, Misbranded, or Counterfeit Drugs Offered for Import.” Destroying adulterated and counterfeit drugs sounds like a good plan but many, if not most, ‘misbranded drugs’ sold in foreign pharmacies are actually the same drugs you can buy at your local pharmacy just with different labeling and packaging. Though sometimes manufactured in a plant not registered with the FDA, they are manufactured in plants registered with another drug regulatory authority. Or they might be a generic version of a brand name drug that is approved in the U.S. but not yet off-patent here. These examples of real, safe and effective medications are usually deemed ‘misbranded’ or ‘unapproved’ by FDA. For more on this see my New York Times op-ed.

To Congress’ credit, before Section 708 goes into effect, regulations must be drafted requiring that consumers, 1) receive notification that their prescription drug orders have been refused import and 2) are provided “appropriate due process” to defend their drug imports before they are destroyed. Unfortunately, as I read it, FDA’s proposed rule did not assure consumers “appropriate” due process. In our comments we proposed that FDA clearly explain to consumers why their drug imports were refused and exactly how consumers can provide testimony to prevent the FDA from destroying their imported drugs. In the final rule, consumers should be able to successfully defend refused drug imports of safe and prescribed medication to have them released not destroyed. They need those medications to safeguard their health, and sometimes even lives.

We also proposed a revision to FDA’s personal drug importation policy so that safe personally imported medication from certain countries with very strong pharmaceutical regulations and pharmacy standards would not be detained or refused. We also recommended continuing actions to shutdown dangerous rouge pharmacy sites but not obtusely conflating them with safe international online pharmacies.

See below to learn more and advocate.

Petition the Government!

Comments by Americans concerned with Section 708

Comments by PharmacyChecker.com to the FDA on Section 708

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Each year, FDA participates in Pangea, a global operation that identifies and shuts down rogue Internet pharmacies, seizes allegedly dangerous medication, and arrests those responsible. We like that Pangea takes actions against rogue online pharmacies that threaten the public health. However, media stories about Pangea can frighten the American public away from safe online sources of affordable prescription medication because they often assert that foreign online pharmacies are all dangerous, which is absurd.

Thankfully, Dan Mangan of CNBC News reminded Americans last week that there are safe international online pharmacies. His article, “Patients cross borders for online deals on medication” explains that PharmacyChecker.com was created to help consumers avoid fake online pharmacies and have peace of mind when shopping for medication internationally. Lee Graczyk, head of RxRights.org, let them know why this is so important: “For some folks, this is the most viable way for them to fill their prescription at a price they can afford.”

The article points out that despite Federal restrictions, Americans purchase medication from outside the United States for personal use. Though the FDA does advise against personal drug importation (wrongly in our opinion), its enforcement is focused on large scale drug importation of medication by doctors, providers, or wholesalers, not individuals. In fact, FDA has never prosecuted anyone for importing medication for personal use. The article also brings up Maine’s recent law that removed state restrictions on personal drug importation. A similar bill was introduced in the South Carolina legislature.

Residents of these states want to facilitate drug importation to help people like Bill. As Mr. Mangan reports, Bill, a resident of New York City, was prescribed Copaxone for macular degeneration. Because Copaxone is not FDA-approved for that condition, Medicare didn’t cover it, leaving him with a ridiculously high out-of-pocket cost. At the suggestion of his doctor, Bill used a Canadian pharmacy. Instead of paying about $5,000 for a 28-day supply, he paid $1,200.

We’re happy with Mr. Mangan’s reporting, as coverage of crackdowns against dangerous pharmacy websites should include balanced information. His coverage included information collected from both supporters for and against personal drug importation and international online pharmacies, and he should be applauded for doing so.

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Today, the New York Times published an Op-Ed by PharmacyChecker.com Vice President Gabriel Levitt entitled “Scare Tactics over Foreign Drugs” which explains that actions by our government and the pharmaceutical industry to frighten people risks leaving them without the medicines they need. I encourage you to read the article.

To learn more about the issues at play check out The International Online Pharmacy Report for 2013: The Good, the Bad, and The Ugly.

 

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So You Want to Buy Cheap Medicine From an Actual Canadian Pharmacy, Here’s The Deal…

(Click here to skip the explanations and view the steps to finding a Canadian online pharmacy)

If you’ve seen one of the latest FDA press releases regarding Canadian pharmacies, you might be a little confused on how to find one. The FDA seems to acknowledge that there are legitimate – and therefore safe – Canadian pharmacies accessible online. Here’s what they say (with one word italicized by us):

“Don’t order medicines from web sites that claim to be Canadian pharmacies. Most are not legitimate pharmacies, and the drugs they supply are illegal and potentially dangerous.

Claiming to be a Canadian pharmacy is one of the hallmarks of Internet sites that sell illegal prescription drugs which, in many cases, are not made in Canada at all, but in a number of other countries. (Even if an online Canadian pharmacy is legitimate, in general, U.S. citizens cannot legally import prescription drugs from other countries. But that’s a separate issue. We’re talking here about fraud).”

The FDA’s focus on protecting you from online pharmacy fraud is commendable because that’s where the real health and safety threats reside. Since they don’t tell you how to find a legitimate, real Canadian pharmacy, we’re providing you with facts and guidance to help you make the right decisions for your health and prescription savings.  Let’s remember, brand name medications sold in Canada and other non-U.S. pharmacies are often astronomically cheaper than ones here at home. (more…)

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An American Doctor’s Position on International Online Pharmacies

The Philadelphia Inquirer continues to cover the issue of high drug prices in the U.S. with an article about Americans purchasing medication from international online pharmacies. The “Ins, outs of getting meds overseas” provides useful information for consumers, most importantly that Americans ordering medication internationally should only do so from credentialed online pharmacies and that the FDA, despite technical prohibitions on personal drug importation, does not prosecute Americans for doing so.

I was particularly intrigued by the remarks of one physician when asked about his patients buying medication from international online pharmacies. He sheds a lot of light on two issues: 1) the serious health crisis surrounding Americans not adhering to prescriptions (not taking their meds) because of high drug costs, and 2) the fundamental difference between online pharmacies that require a prescription and those that don’t. In describing his conversation with cardiologist David Becker, journalist Paul Jablow writes:

When patients ask him to give them a written prescription rather than sending the scripts electronically to a pharmacy, he says he assumes they’re buying overseas from a reputable pharmacy, and “I have no problem with that.” What concerns him more, he says, are the patients who come to him and say they’ve been neglecting their medications for months.

While we would strongly caution a consumer against buying prescription drugs from an online pharmacy that was not verified by an experienced credentialing organization, the doctor’s assumption of safety is somewhat warranted. That’s because, unlike Americans risking their health by seeking medications online without a prescription from rouge online pharmacies, his patients have real prescriptions. Prescription requirement is a very strong indication of, but not necessarily a guarantee of, an online pharmacy’s safety. Dr. Becker is apparently aware of this and his greatest concern is where the focus of more healthcare professionals needs to be: drug affordability.

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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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Why You Should Tell Seniors to Get On the Net

The Internet offers almost everything, from news on sports and politics to forums and games. A new study from the Pew Research Center suggests that the Internet may even be useful in improving health outcomes. Make no mistake, the study doesn’t say that Internet access and use makes you healthier, but it does find that Americans with chronic conditions are more likely than regular Internet users to seek out information about their health. Specifically, that means gathering information online about medical issues, consulting online reviews about drugs and other treatments, and reading or watching something online about some else’s personal health experience.

The problem is that people with chronic conditions are less likely to be using the internet in the first place. Only 72% of adults with chronic conditions use the internet, compared to 89% of adults with no chronic conditions. Part of this gap is due to the fact that older Americans are more likely to have a chronic condition and also less likely to use the Internet. Only 53% (and growing) of seniors are online, compared to 85% of all Americans. It seems that the group who could make the best use of internet resources is those least likely to access them. One company’s newsletter suggests that getting Americans with chronic conditions online will help them get facts about their condition, prepare them to discuss data with their doctor, and also look for others who share their conditions.

Here at PharmacyChecker, we know that greater internet access will also help more consumers save money on their medication. We hope that Pew or other research organizations continue to study the effects of the internet and internet access on health, especially toward the goal of helping Americans find affordable healthcare, which has proven to improve health outcomes.

 

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Are Mail Order Pharmacies Good for Patient Health?

Mail order pharmacies, including online pharmacies, have their benefits; your medicine comes right to your doorstep, you have more privacy regarding your medication, and, usually, you don’t have to spend as much as you would in a brick-and-mortar pharmacy. A new study of diabetic patients, “Safety and Effectiveness of Mail Order Pharmacy Use in Diabetes,” finds that using mail-order pharmacies may actually prevent negative health outcomes more so than walk-in pharmacies.

The study focused on diabetics because they are at high risk of being prescribed contraindicated medications (ones that would interfere with their normal drug regimens) and often require laboratory work to monitor the effectiveness of their medications. Some may think that patients using mail order pharmacies will experience more negative health outcomes than those using walk-in pharmacies because they do not have face-to-face interactions with pharmacists.

The study found that use of mail order pharmacies “was not negatively associated with patient safety outcomes overall, suggesting that mail order use does not serve as a barrier to receiving primary and preventive care services for most patients.” In fact, the study showed that mail order pharmacy users under 65 were less likely than local pharmacy users to visit emergency rooms. However, mail order pharmacy users under 65 on a subset of diabetic medications were more likely to forego a recommended serum creatinine lab test within 30 days. Patients over 65 who used mail order pharmacies were also less likely than local pharmacy users to have preventable emergency room visits. Despite the health benefits of mail order pharmacy, the study cautions that preventive and primary care must be kept in mind when encouraging their use.

We’re pleased to see the health benefits of mail order pharmacies highlighted in this study; after all, reputable online pharmacies are mail order pharmacies that allow patients to access medication safely and affordably.

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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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