More than 50 health professionals signed a letter addressed to President Donald Trump, members of Congress and the U.S. Food and Drug Administration (FDA) asking that we expressly permit personal prescription drug importation. The letter comes along the ever-swelling wave of patient and provider outrage against Congress’ and the president’s failure to act on drug prices, a result of the Big Pharma/U.S. politician relationship, which is only growing cozier.
The letter states:
“Our patients, who have purchased medications through the help of pharmacy storefronts or international online pharmacies verified by PharmacyChecker.com, have received safe and effective medications from legitimate pharmacies in Canada and several other countries. We respect that the FDA is charged with protecting our nation’s medicine supply from counterfeit and otherwise substandard drugs. However, there is no logical reason why the FDA should interfere with the delivery of safe and effective medications to our patients.”
Tagged with: doctors, FDA, Florida, healthcare providers, pharmacychecker recommended, prescription justice
The future of your ability to buy lower-cost medicine online from another country was indirectly discussed recently during congressional hearings with Facebook Chief Operating Officer, Sheryl Sandberg, and CEO and founder of Twitter, Jack Dorsey.
The issues on the table were much more grandiose-sounding than importation from Canada or buying medication internationally using the Internet. Russian meddling in our elections; political bias on Twitter against conservative and Republican ideas; personal privacy protection; and lots of discussions that affect 1st Amendment protections.
The takeaway by some experts is that Congress is getting ready to regulate the Internet.
As it applies to online access to safe and affordable medicine, Internet regulation could lead to access protections or access denied. In short, the pharmaceutical industry is actively engaged in driving safe international online pharmacies offline. The industry can often get what it wants from Congress and so the dangers of Internet censorship to block access to or shutdown international online pharmacies are real.
For a variety of posts on this, see our section on Internet Freedom.
Google’s top executives were invited to the hearings yesterday, but they declined to attend. Some accused them of being arrogant. But the company itself noted that search engines, like Google and Bing, are not the same as social media networks, like Facebook, Twitter, and Instagram. Google’s search engine was not used by bad actors in the way that occurred on Facebook, for example.
Google’s absence reminded me of Ms. Sandberg’s appearance at another Congressional hearing when she was vice president of global sales for Google in 2004. That hearing of the Committee on Governmental Affairs; Permanent Subcommittee on Investigations focused on Internet access to medication and importation. In prepared remarks, Ms. Sandberg stated Google’s position on importation and online pharmacies:
“As a provider of Internet-based information tools, Google has no position on the broader merits of the drug importation debate, or on the optimal mechanisms for regulation of online pharmacies; rather, our interest is to preserve the ability of Internet users to find useful and relevant information, including information about licensed pharmacies.”
That was then; this is now. Fast forward to last spring: Google has made a deal with the FDA that undermines its earliest and best principles as articulated by Ms. Sandberg. That deal is not about blocking Canadian pharmacy ads on Google. That’s old news in bad policy-making. The new deal is that Google will remove search results if asked by the FDA, based on its administrative decisions, without a court order. These are so called “organic” searches, not paid results.
To date, the FDA has yet to use this new permission from Google to censor safe international online pharmacies. And it continues to use due process through warning letters to rogue online pharmacies, as it did to combat sites selling tramadol without a prescription. I agreed with the FDA on that action because those sites have proven to harm people who are addicted to opioids.
But, you know, pharmaceutical companies have spent four billion dollars lobbying Congress over the last 20 years or so. And if Congress is legislating new regulations to control behavior on the Internet, Pharma won’t be far behind with its goal to stop Americans from buying more affordable meds online.
Tagged with: congressional hearings, facebook, Google, jack Dorsey, Sheryl Sandberg, twitter
The 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:
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.
Tagged with: fentanyl, opioids, tarbell, tramadol, warning letters
Generic 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.
Tagged with: article 60, intellectual property rights, patent, TRIPS, WTO
EpiPen, 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.
Tagged with: EpiPen, mylan, Pfizer, shortages
The 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.
Tagged with: fentanyl, Freedom of Information Act, Obama, The New York Times, trump
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.
Tagged with: CIPA, fentanyl, PSM, Purdue