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FDA Warns 21 Online Pharmacies to Stop Selling Unapproved Opioids

FDA Crackdown on Illegal Online PharmacyThe FDA is warning 21 online pharmacies to stop selling certain prescription opioid drugs to people in the U.S.

According to the FDA, the 21 websites at issue are operated by four separate networks:

CoinRx,

PharmacyAffiliates.org,

PharmaMedics,

and MedInc.biz.

Each network received a similar warning letter from the FDA, which singles out their alleged illegal sales of unapproved and misbranded tramadol, also noting that a prescription was not required.

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Intellectual Property & Personal Drug Importation – Fun Facts in International Law

Intellectual PropertyGeneric drugs often become available earlier in other countries and that means greater affordability. Generally, it’s a violation of a drug companies’ intellectual property rights when a company sells a generic in a country before the patent has expired. But what happens if you import a generic version of a drug, one that is lawfully-made and sold in a country where it is available but still on patent here, to fill a prescription? Are you committing an intellectual property violation?

According to a side agreement (of the General Agreement on Tariffs and Trade) among countries party to the World Trade Organization, called TRIPS (Trade-Related Aspects of Intellectual Property Rights), countries are not obligated to enforce IP laws for small importations of goods, which include pharmaceuticals.

You can find this in Part III, Enforcement of Intellectual Property Rights, Article 60:

De Minimis Imports

Members may exclude from the application of the above provisions small quantities of goods of a non-commercial nature contained in travelers’ personal luggage or sent in small consignments.

The “above provisions” refer to enforcement actions against intellectual property violations that involve goods crossing borders (in person, by plane, sea, through the mail, etc.). If you read closely, it includes the word “may.” That means, in theory, you could be accused of an IP violation, but I know of not a single instance of that happening to an individual importing a medicine for personal use.

What is clear is that there’s general agreement (no pun intended) that individuals should not be subject to IP enforcement actions for importing a product for personal use. When it comes to a life-saving medicine, this seems like common decency – even natural law.

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Warning About Buying EpiPen Online to Deal with Shortages

EpiPen ShortageEpiPen, the emergency epinephrine auto-injector medicine, is in short supply in the U.S. and other countries, such as the U.K. and Canada. Now, parents of kids who need to carry around EpiPen Jr. are not just worried about the cost of EpiPen but if they can get it at all. If you are considering buying EpiPen online, here’s my warning:

Only Buy EpiPen from Verified Online Pharmacies

When it comes to fast-acting, life-saving products, buying online from a rogue online pharmacy can turn out to be deadly. If you get a fake or expired product, then it might not work. Enough said. The message is clear: do NOT buy from an online pharmacy that isn’t one associated with your neighborhood pharmacy. If you decide to buy online, stick to online pharmacies that are verified. That includes online pharmacies verified by us, PharmacyChecker, or LegitScript, the National Association of Boards of Pharmacy VIPPS program, or the Canadian International Pharmacy Association.

You can buy brand-name EpiPen online from Canada using verified online pharmacies: a two pack for about $230.

Buy Generic EpiPen at U.S. Pharmacies

When it comes to cost and availability, you may not have to look internationally for savings. In the U.S., there’s a generic version made by the same company that makes the brand version, and it’s much less expensive. According to GoodRx, you can buy the generic with a discount coupon for almost half the price of the brand-name sold at Canadian online pharmacies: $125. The brand version in the U.S. is over $600!

Where are all the EpiPens?

According to Market Watch, manufacturing problems are causing EpiPen supply problems. The generic drug company, Mylan, has the license to market and sell EpiPen in the U.S. and Canada, but the brand-name drug company, Pfizer, owns and runs the plant that makes the drug. To make a very long story short, the FDA has cited problems with Pfizer’s protocols for assembling the drug. Pfizer is trying to up its game, but the process is taking some time.

There are epinephrine alternatives to EpiPen, brand and generic. They include Adrenally and Auvi-Q, which might be more affordable. Consumer Reports has a good article on these products, although I’m not sure about their current availability.

The Market Watch article suggests that you can still get the product, but they make it seem a lot more challenging than it should be. If you choose to buy it online, whether for availability or cost, stick to verified sites.

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FDA Focuses on Illegal Fentanyl Imports, Neglects Off-Label Prescribing

FentanylThe FDA has made it it’s business to shine a bright light on the evils of illegal fentanyl imports, which are sometimes sold online. That focus seems like it’s a good one. Illegal fentanyl imports get into the hands of drug dealers who use the ingredients to make counterfeit, opioid-based drugs. They sell them to addicts who too often overdose and die. I’ve written a lot about the FDA’s crackdown on illegal fentanyl imports being misused to stop imports of prescription medicines on their way to American patients from Canada and other countries. However, something much more troubling actually has gone down over the past few years.

According to documents obtained through a Freedom of Information Act request by the John’s Hopkins Bloomberg School of Public Health, the FDA ignored information about off-label prescribing of the most dangerous prescription opioid drugs: fast-acting fentanyl or transmucosal immediate release fentanyl (TIRF). Those drugs were approved to treat the most serious pain experienced by cancer patients. Instead, drug companies encouraged off-label prescribing for patients experiencing lower levels of pain and certainly did not have terminal illnesses.

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Real Opioid Online Drug Dealers Indictment Unrelated to Rx Import Savings

Indictment of Evelin Bracy and Jorge Rodriguez Lopez Here’s a real story about online opioid drug dealers getting indicted and how pharma front groups conflate the opioid crisis with prescription drug importation. I write “real” to juxtapose rogue online pharmacies—that illegally sell addictive drugs—and safe international online pharmacies that don’t sell addictive drugs at all.

On July 9th, the U.S. Department of Justice for the Southern State of New York announced the indictment of Evelin Bracy and Jorge Rodriguez Lopez for illegal distribution of controlled drugs, including an analog of the opioid pharmaceutical Fentanyl – called U-47700. They are also accused of selling these drugs on the Internet from what the DOJ refers to as a website “purporting to be an online pharmacy.” The indicted parties were also alleged to have sold drugs under pharmaceutical names, oxycodone and alprazolam, that were found to have other ingredients, implying that the products were counterfeit. These counts can technically land a person in jail for 40 years.

If the allegations are true, then we’re dealing with bona fide drug pushers. The Partnership for Safe Medicines (PSM), a Pharma-funded non-profit group that seeks to conflate such drug dealing and counterfeiting with pharmacies in other countries that sell affordable prescription medicines to people here in the U.S. PSM is keeping a web diary of law enforcement busts that help stop the deadly fentanyl trade, which is taking the lives of thousands of Americans each year. We applaud law enforcement for disrupting these opioid dealing operations and bringing their orchestrators to justice.

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Did Instagram Shut Down our Account as Part of its Crackdown on Opioid Drugs: Protecting Patients or Big Pharma Censorship of Lower Drug Prices?

Instagram shut down our account

The pharmaceutical industry, generally, does not like our company. 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 it for personal use.

But is that a reason for Instagram to shutdown our account!? That action is nothing less than corporate-inspired, government-encouraged censorship. Mike Masnick of TechDirt refers to this as the soft underbelly of Internet censorship. Also, please read this background from the Electronic Frontier Foundation calling out Big Pharma on this issue.

Congress and the FDA are banging on the door of Facebook, Google, Instagram, etc. about stopping people from selling opioids on their platforms. We can debate until the cows come home about what content should be self-censored — meaning removed without a court order — but please hear me out on why Instagram’s dissing PharmacyChecker doesn’t even come close to acceptable and let us know if you agree or disagree.

First of all, PharmacyChecker.com does not sell or facilitate the sale of medication. Medications are not purchased on our site and we have no role in the processing of prescription orders. We verify credentials and publish information about online pharmacies and drug prices. That information is globally accessible on the Internet.

By the way, our Verification Program bans online pharmacies that ship controlled drugs of any kind into the U.S. This includes not only prescription opioids, but also Valium, Xanax, and Adderall. We’re with the DEA on strict controls and highly attuned to and concerned about the opioid crisis. I have friends who view our policy as too conservative. You get the picture.

We agree with cracking down against dealers of opioids, with Fentanyl being the greatest concern. On the other hand, we have seen Pharma and the government use a crackdown against addictive prescription drug sales online to veer into a crackdown against imports from Canada of decidedly regular meds that treat asthma, diabetes, depression, high cholesterol and blood pressure, etc.

We launched PharmacyChecker in 2003 to help people searching the Internet for lower medicine prices from real pharmacies, domestic and international. Our verification program is run by a licensed PharmD from Massachusetts, Dr. Shivam Patel. Pharmacies listed in our program must require valid prescriptions, sell only personal-use quantities, have a pharmacy license, and cannot sell controlled drugs of any kind internationally, into the U.S.

Feel free to read about our extensive protocols for verifying international online pharmacies.

In 2012, I was asked to write a chapter in a book called Hacking Politics, which is now published as an anthology about the battle to kill the Stop Online Piracy Act. My chapter was called the “Online Pharmacy Story.” In short, due to lobbying by the pharmaceutical industry, SOPA contained language that would have potentially made PharmacyChecker.com illegal at a maximum; at minimum, it would have increased our intermediary liability exposure. I strongly opposed it. And yet we see big industries moving SOPA by a thousand cuts.

I believe there’s some chance that Instagram dissed our account accidentally, based on a sweep of sites having to do with drugs, medicines, pharmacies, etc. But there’s also a small chance that Pharma’s influence led to the direct shutdown of our account as a slap in the face to PharmacyChecker advocacy efforts. I’m constantly criticizing Pharma’s propaganda about importation and online pharmacies our blog, in the New York Times, RightsCon, and directly to members of Congress in my testimony.

In fact, last year I caught PhRMA, meaning the big pharma trade association, placing Google ads using our name to dissuade people against importation of lower-cost medicines. As I wrote in our blog, that was a badge of honor but kind of disconcerting as well.

Late last month, the FDA called Instagram, Google, Reddit, and many others, to what was called the FDA Opioid Online Summit. I blogged about it beforehand mostly to note that groups funded by Pharma were well represented, ones that focus on opposing importation of lower-cost medicines and use the opioid crisis for that goal. Initially, the summit was billed as a public event, but it turns out that journalists were locked out and those that covered the public part did conclude that opioids were not the sole target, but cheaper meds were open season, too.

We want our Instagram account reinstated on principle, yet no one has responded to our multiple attempts at contacting Instagram’s customer support.

Anyone willing to weigh in on this?

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