This week, I attended ASOP Foundation’s symposium titled: “Spotlight on Illegal Online Sales of Medicine.” ASOP is short for the Alliance for Safe Online Pharmacies. That organization, which started with funding from Eli Lilly and the National Association of Chain Drug Stores, has often received criticism on these blog pages. Like other Pharma-funded initiatives, its goals are aligned with the pharmaceutical industry and one of its main objectives is lobbying against personal drug importation. It often conflates, through its public education programs, safe international online pharmacies with dangerous rogue websites. However, a good part of its work is helping raise awareness and policy development to stop rogue sellers of counterfeit and substandard medicines from harming patients, and that’s something PharmacyChecker is 100% behind.
Much of ASOP’s work was the brainchild of LegitScript, a founder of ASOP. Truth be told, PharmacyChecker is the expert in safe international online pharmacies and providing consumers with useful guidance about them, but LegitScript/ASOP are the experts in rogue online pharmacies and pushing policies to shut them down. It’s disheartening that they seemingly refuse to separate safe importation from rogue online drug sellers. But I’ll put that aside for now.
I’m going to focus today’s post mostly on presentations by two high-ranking FDA officials. The first was the morning’s keynote speaker, Donald Ashley, JD, FDA’s Center for Drug Evaluation and Research Director of Compliance. His focus was the FDA’s efforts to combat illegal opioid sales online and those being imported through international mail facilities. I’ve written about how such actions can be used against safe personal drug imports. While that would be unfortunate, Mr. Ashley was meticulous in communicating that his efforts are strictly focused on opioids: shutting down fentanyl and other opioid-selling sites; detecting and stopping illegal opioid imports; and, through the Office of Criminal Investigations, charging and prosecuting these online opioid drug dealers.
Tagged with: ASOP, Donald Ashley, FDA, Michael Kopcha, Office of Pharmaceutical Quality
As reported in Kaiser Health News, the personal drug importation cause had a little victory recently. A bill focused on the opioid crisis, H.R. 6, slated for final passage, includes language that is protective of individuals who import medicines for their own use, even illegally.
While its focus is curbing opioid abuse, H.R. 6 reforms drug importation laws that have nothing to do with opioids but empowers the FDA to stop imports of prescription drugs considered by the FDA to be misbranded (which can mean prescription drugs that have a Canadian not U.S. label). Those reforms will make it more difficult on people and business engaged in illegal, wholesale prescription drug importation. An earlier version of H.R. 6, from the House, included language that exempted imports for personal use. That language was quietly removed in a Senate version, which passed in that chamber. Then, apparently there was some protest among certain members of Congress and the language was put back in during conference – and is now in the final law.
Now I’m getting a lot of questions about the law and personal drug importation. There are several parts of law, regulation and policy very favorable to personal (but not wholesale) importation, which have yet to be compiled and addressed in one article. I endeavor to do that here. The gist is that Congress doesn’t want the FDA to unnecessarily stop Americans from buying medication from Canada and many other countries – even if it’s technically illegal. The position of Congress is clear in law if you look comprehensively and closely.
(more…)Tagged with: Congress, enforcement discretion, FDA, personal importation policy
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?
Tagged with: Big Pharma, Censorship, FDA, Google, Instagram, SOPA