Something unexpected happened at a dog and pony show staged at the National Press Club on April 4, where the Partnership for Safe Medicines (PSM) gave its campaign against prescription drug importation and international online pharmacies the imprimatur of technocratic expertise. Former FDA Commissioner Dr. Andrew Von Eschenbach, in opposing importation as unsafe, and “frightening” said that 29 countries have regulatory systems for drug safety comparable to the U.S. Was that a mistake? No. We need to get that list of 29 countries and create standards for distribution and refine guidance for consumers to help more Americans import lower cost medications from those countries.
I derived the number 29 because Dr. Eschenbach said: “of the 96 countries around the world that can supply drugs only 30% have a functional regulatory infrastructure that’s comparable to the one that we have at the Food and Drug Administration.” Simple math showed 30% of 96 is 28.8. I rounded to 29!
Granted, Dr. Eschenbach would say that I was taking his words out of context. (more…)
Yes. Last week, the four most recent commissioners of the U.S. Food and Drug Administration sent an open letter to Congress declaring that an importation bill, The Affordable and Safe Prescription Drug Importation Act, introduced by Senators Bernie Sanders, Cory Booker, and Bob Casey, if passed, would jeopardize consumer safety. The bill, as described here, provides for an extensive oversight role for the FDA to help individuals and pharmacies import lower cost medications from Canada.
Don’t get me wrong: the former FDA leaders make pertinent points about regulatory issues implicated in reforming our importation laws, which should be noted – and then used to implement new regulations to expand importation from Canada – not used to pretend safe importation is impossible.
Thankfully, when the Washington Post covered this last week, they included something I said to the reporter: “The Internet has been a lifeline of affordable medicines, imported for personal use by using safe international online pharmacies that require valid prescriptions…” And if I had more to say… (more…)
Personal drug importation works! This week, drug company Marathon announced it is postponing the launch of Emflaza, its recently FDA-approved version of an off-patent drug called deflazacort, in the face of heavy scrutiny by Senator Bernie Sanders and Congressman Elijah Cummings over its price tag – $89,000 a year. This drug, which treats Duchenne Muscular Dystrophy (DMD), is available under the brand name Calcort in the United Kingdom at about 99% less (about $750) than the current U.S. “postponed” price. Generic versions of deflazacort are also available internationally among verified online pharmacies at an annual price tag of about $650.
For some background on the disease and treatment: DMD is a “genetic disorder characterized by progressive muscle degeneration and weakness.” It mostly afflicts boys, with onset ranging from ages 3-5. It’s caused by the absence of a protein called dystrophin. For more, see the Muscular Dystrophy Association’s (MDA) website. According to the MDA, corticosteroids, including deflazacort, help slow the disease’s progression.
For a critique of the Emflaza price read Sanders and Cummings’ letter. No one could do better than that. Marathon CEO Jeff Aronin attempts to rationalize the price here but it almost reads like an apology. They argue that no consumer will deal with the $89,000 price tag because health insurers only charge a $20 co-pay and they have patient assistance programs to help the uninsured. It’s never that perfect, at all: people always slip through the cracks and we’re not forcing people to go without needed medication or go into bankruptcy to get it. Right?
So now a fist full of truth about this medication and safe online access to affordable medicines to shine a bright light on the lifeline that is personal drug importation… (more…)
I’ve been around the consumer health world for long enough to have a good idea of which groups and individuals really want to find and spread the truth to Americans. Joe and Terry Graedon of the People’s Pharmacy are high on the list. So I was honored to read what they wrote about us (as people, the CEO and me, and as a company) in the latest edition of The Graedon’s Guide to Saving Money On Medicines:
“We have met the founders (Tod Cooperman, MD and Gabriel Levitt, MA). They have impressed us with their commitment to helping U.S. citizens obtain affordable and reliable medications. Even more helpful than the list of pharmacies are the PharmacyChecker.com price comparisons.”
“I represent safe and affordable imported medication. This bathwater is dangerous rogue pharmacy websites!”
Earlier this month, the U.S. Food and Drug Administration published a press release about Operation Pangea, an annual global initiative led by INTERPOL “to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products on the internet.” This is the ninth annual operation, and each year I wonder if FDA will throw the baby out with the bathwater.
There are, according to FDA’s own sources, tens of thousands of drug-selling websites. Most of them are considered “rogue” by PharmacyChecker.com. Where the FDA and Operation Pangea successfully shut down sites (whether lawful or not) that intentionally sell counterfeit medications, or even online pharmacies that sell real medications but without the qualifications or pharmacy safety protocols to do so, we applaud their actions. Shutting down dangerous online pharmacies – throwing out the bathwater – is noble.
In February of last year we submitted a policy paper that I wrote to congressional committees with jurisdiction over laws and regulations that affect access to safe and affordable medications. Entitled “Online Pharmacies, Persona Drug Importation, and Public Health,” I argued that safe international online pharmacies are a boon to public health because they enable consumers to afford prescribed medications, and that overzealous enforcement of drug importation regulation could negatively affect access to those sites. Actions taken by FDA and through Operation Pangea would seem to cross the line from public health to Big Pharma profit protection where they curtail access to the safest international online pharmacies, which is throwing out the baby.
I’m pleased to announce that the Prescription Justice Action Group (PJAG) has a new and improved website; and for those of you that follow PharmacyChecker.com’s advocacy efforts on these blog pages I believe you’ll like it! The site just looks a lot better, it’s easier to use and therefore more helpful.
As a reminder, last November we announced the formation of PJAG, a non-profit organization dedicated to defending Americans if the FDA refuses and threatens to destroy their personal drug imports and advocating for policies to lower domestic drug prices. The motivation to start PJAG was the passage of legislation back in 2012 giving new, potentially harmful regulatory powers to the FDA. Often referred to as Section 708, the law allows FDA to more easily destroy personally imported medication. The new rules went into effect on October 15th of 2015.
FDA may be seizing medications in larger numbers ordered from rogue online pharmacies but to date they have not greatly increased refusals of medication ordered internationally from PharmacyChecker-approved online pharmacies. I write “greatly” because I’ve heard that there have been some increases. Historically, over 99% of prescription drug imports ordered from international online pharmacies that require a prescription have reached the patient.
PJAG’s website provides guidance to show consumers how to submit a letter to the FDA to defend a medication they have ordered from an international pharmacy, if they get a letter that it’s being held by the FDA and subject to destruction. It’s not easy and it takes patience but following PJAGs guidance could be helpful: at a maximum to get your medication back in the unlikely event it’s taken, and at minimum to send a message to the FDA that they took medication from you and now you can’t afford it. PJAG blogs that it’s working to create a web form portal to make the submission process easier. We’ll report back when that’s up and running.