From time to time, we participate in the public policy process by submitting public comments to government agencies requesting them. In May of this year, after introducing the Trump administration’s blue print plan for lowering drug prices, the Department of Health and Human Services (HHS) asked the public to comment on the Trump administration plan and/or make recommendations for lowering drug prices and out-of-pocket prescription costs.
I submitted comments that were laser-focused on PharmacyChecker’s area of greatest expertise, personal drug importation and online pharmacies. My comments clarify why and how properly-verified, international online pharmacies are a lifeline of safe and affordable medicines for Americans.
PharmacyChecker Public Comments to HHS July 13, 2018
The basic recommendations offered in the comments are below:
Tagged with: Donald Trump, FDA, HHS, legalizing personal drug importation
- Under Section 804 (j) of the Food, Drug and Cosmetic Act, the Secretary of Health and Human Services should expressly permit medicine imports for personal use to empower patients seeking affordable medication.
- Per the above, implement the Australian model of making personal drug importation legal with caveats to prohibit personal use imports of controlled drugs, especially prescription narcotics.
- The FDA should end its blanket warning against ordering medicines online, imported for personal use from pharmacies in Canada and other countries, and instead provide guidance on best practices for those who choose to import.
- The FDA should stop seizing personal imports of non-controlled medicines arriving from pharmacies that the FDA knows are licensed and require valid prescriptions.
- The FDA should take no enforcement actions against international online pharmacies that it has reason to believe are the safest international options available to Americans and instead focus on those that represent the gravest threats, particularly ones that sell prescription narcotics.
The heat is rising on the pharmaceutical industry because of high drug prices. The politically and economically middle-of-the-road editors at Bloomberg published an opinion piece this week called “U.S Prescription Drug Costs Are a Crime.” The gist in the article is that policy tweaks are not enough, pointing out that President Trump’s rhetoric on drug prices is much stronger that the reality of his actions. Major changes are needed, such as drug price negotiations in Medicare and making importation of lower-cost medication legal (something one in ten Americans already do, according to Bloomberg).
I love this article, but it doesn’t state clearly why drug prices are a crime. The answer is tens of millions of Americans aren’t filling prescriptions because of them each year. Many get sick and some even die because of them. For some cancer patients, it’s extortion. “Give me the money,” pharma says. “Or die.” Your money or your life.
Still, we all know that a crime is an act that violates laws of a governing authority as proven through due process of those laws. And our laws allow the pharmaceutical industry to charge the prices referred to as a “crime” in Bloomberg.
That said, there is litigation targeting drug companies, pharmacies, and insurance companies/PBMs for violating laws to keep drug prices high. Examples include insulin price fixing, collusion between health insurers and pharmacies, and pharmacy kickbacks to PBMs. However, to an extent not found in Australia, Canada, New Zealand and the United Kingdom, U.S. laws permit—even encourage—increasing drug prices out of reach for patients who need them. Lawful but unjust.
It gets sicker and more unjust: technically, a patient who re-imports a medication from Canada because it’s her only affordable option is subject to jail and fines. No, that’s never happened, but it’s despicable that the law makes it a possibility while drug prices continue to climb.
Justice and law, when it comes to prescription drug prices in America, are fully out of whack.
Tagged with: bloomberg, collusion, crime, drug price negotiation, importation, kickbacks
PharmacyChecker.com is proud of the work we do to advocate for your access to affordable medication, and we welcome you, your sister, and your sister’s husband’s cousin to join us!
The greed of pharmaceutical companies has become overbearing: not only their price gouging, but rampant public relations and lobbying campaigns attempt to muzzle the majority of Americans who demand lower drug prices.
Tagged with: Advocacy, Drug Prices, Lower Drug Prices
Let’s get into semantics. The word “ensure” is defined as to secure or guarantee, to make sure or certain, or to make secure or safe, as from harm. I submit that the FDA cannot ensure the safety of Canadian OR U.S. drugs, but that doesn’t mean they are not safe and effective…
Pharmaceutical Regulation in Canada
The precise communications of the U.S. Food and Drug Administration have changed over the years on why it’s illegal for Americans to buy medications from Canada by personally importing them. Often the implication is that the agency cannot “ensure” or “guarantee” the safety of medications sold in Canadian pharmacies – and that’s why it’s illegal. Additionally, another reason used by the FDA is that the drugs sold in Canada may not be approved by the FDA. These are not good arguments against buying lower cost medications from Canada because the Therapeutic Products Directorate of Health Canada, the FDA’s counterpart, is responsible for regulating the prescription drugs sold in Canadian pharmacies. Like the U.S., Canada has very strict rules to help ensure drug safety.
Neither country can guarantee the safety, efficacy and quality of medications in the two countries. However, their regulatory mechanisms have proven more than adequate, if not superior, so that patients buying medications will almost always obtain a properly manufactured medication. (more…)
Tagged with: ensure, health canada, regulation
Getting the truth about Online Pharmacies
The economist and drug safety expert Roger Bate, PhD, affiliated with the American Enterprise Institute, published a short article this week, the title of which says it all: “Credentialed online pharmacies are so safe that peer review literature is no longer interested in results showing it.” The gist is that he and colleagues have been testing medications for several years, since 2008, as mystery shoppers ordering online domestically here in the U.S. and internationally for import. The research shreds the myths of the drug companies by presenting peer-reviewed data to derive what are called “facts” about the Internet and importation. The main fact proved is that importing medications, ones ordered online, can be equally safe as U.S. pharmacies.
In the studies from 2008-2016, 822 online medication orders were tested: 275 medications from 22 international online pharmacies verified by PharmacyChecker.com (12 of which are also verified by the Canadian International Pharmacy Association); 127 medications from eight U.S.-only online pharmacies verified by the National Association of Boards of Pharmacy and/or LegitScript.com, and the rest from websites with no verification.
Verified U.S. pharmacies sold zero counterfeits but one (out of 127) order of generic Cipro was substandard. Verified international pharmacies sold zero counterfeits but one (out of 275) order of generic Cipro was substandard. On a percentage basis, the PharmacyChecker.com-verified websites performed best (but that’s nitpicking). And for those of you thinking, well, one was substandard…that same medication is available at your local Walgreens or CVS. Read the research.
In contrast, online pharmacies with no verification (Dr. Bate calls it “credentialing”) sold eight counterfeits and 16 substandard drugs (out of 332 tested).
How about prices? When it came to brand name drug prices, the studies showed that credentialed international pharmacies were about 60% cheaper. (more…)
Tagged with: AEI, legatum institute, Roger Bate, searle freedom trust
Principles to guide the Internet community on ethical medication sales
A few months back, I wrote about a panel that I put together as part of my work with PharmacyChecker.com and Prescription Justice, a non-profit group dedicated to ending the crisis of high drug prices in America. The panel was one of hundreds of sessions at the RightsCon Conference in Brussels, an event that brings together Internet freedom, human rights and social justice activists. The panel discussed issues related to buying medication online, Internet freedom, importation and drug affordability – and the negative impact of the pharmaceutical industry on all of the above.
Essentially, drug companies have spent millions of dollars on funding “non-profit” groups, public relations efforts, lobbying Congress and international organizations, Interpol (I kid you not), etc., with the goal of making it hard, if not impossible, for people to buy safe and lower cost medication online from other countries, which include people in America, that can’t afford it locally. Their activities intentionally conflate the intentional sale of counterfeit and substandard drugs with safe international online pharmacies.
The panel was a great step forward in giving the consumer side of this issue a larger voice. The panelists discussed and edited a draft set of principles on medication sales and the Internet. It took a while, but, on June 15, 2017, Knowledge Ecology International and Prescription Justice finalized and endorsed what we’re calling the Brussels Principles, which are published below. (more…)
Tagged with: accessnow, brussels principles, KEI, Rightscon