FDA Commissioner Scott Gottlieb, MD
This week, FDA Commissioner Scott Gottlieb said something revolutionary about the role of the FDA. For many years, the agency has maintained that its sole focus when it comes to regulating drugs is to ensure their safety and efficacy, but that drug prices are beyond its purview. In remarks pertaining to the FDA’s new initiative to speed up generic drug approvals of complex pharmaceuticals, Gottlieb stated that “if consumers are priced out of the drugs they need, that’s a public health concern that FDA should address.”
To those who support safe importation of lower-cost medications, that statement was the shot heard around the world. Indeed, drug prices are a public health concern. If we’re using logic, reason, and commonsense, it becomes untenable from a public policy and health perspective, grounded in basic medical ethics, to prohibit or even discourage importation of lawfully-manufactured medication by individuals who can’t afford it locally. (more…)
Tagged with: FDA, FDA Commissioner, Gottlieb
When it comes to the topic of pain medication these days, we usually read about prescription opioid abuse, which tragically claims tens of thousands of lives each year. According to a recent article in the New York Times, while the landscape of dangers is different, we should also be concerned about every day, over-the-counter pain medication. NSAIDs (nonsteroidal anti-inflammatory drugs) are common pain relievers you may keep around the house to relieve an occasional headache, toothache or post-workout soreness. They are also used to treat fever, arthritis, menstrual pain, migraines and inflammation. Aspirin, ibuprofen, and naproxen are among the over-the-counter NSAIDs you’re probably most familiar with.
Particularly for those with a history of coronary artery disease, NSAIDs can cause serious health issues because they can clog your blood vessels. For others, NSAIDs can do harm to your digestive tracts. Other side effects, according to the article, include, “ulcers, bleeding, kidney failure and, in rare cases, liver failure.”
It appears that topical formulations, such as ointments, perhaps have minimal or fewer side effects. Here’s the rub…(pun absolutely intended)
Tagged with: Aspirin, Diclofenac, Ibuprofen, New York Times, NSAIDs, Opioid Abuse
With insulin prices skyrocketing, no wonder the diabetic community is taking to social media to network and share their experiences as they swap tips and tricks not only for moral support, but also financial.
This month, we received an interesting consumer comment via our Facebook page asking if we knew that Americans are driving to Canada to buy insulin without a prescription. Well, no. As our primary focus is mail-order pharmacy, it wasn’t on our radar. Nevertheless, it sparked our interest and we’d like to share our findings with the PharmacyChecker community.
After calling 20 pharmacies across Canada (specifically in the following cities: Québec City, Toronto, Alberta, Victoria, Winnipeg and Regina) the answer is clear: Americans can obtain insulin without a prescription in Canada. All pharmacists that I called reported—rather matter-of-factly—that you do not need a prescription for any insulin product, which would include Lantus Solostar, Humalog and Levemir. We specifically talked about Lantus Solostar, a popular, long-acting insulin. The price in Canada for a three-month supply of Lantus Solostar (3 ml) is currently around $447.00 while the average retail price in the U.S. is a staggering $1,160.39. Apparently, they practice what they preach: all patients—including Americans—do not need a prescription to obtain insulin in Canada. While a prescription is not needed, the drugs are available only from the pharmacist and must be retained within an area of the pharmacy where there is no public access and no opportunity for patient self-selection (also known in the U.S. as Behind the Counter (BTC).
There are some important nuances about insulin sales in Canada that might interest you. To start, insulin is not on the Health Canada Prescription Drug List. Health Canada—the regulatory agency in Canada that is comparable to the FDA in the United States—lists insulin as a Schedule II drug. The word “schedule” in the U.S. is used to identify those medications associated with greater potential for addiction, such as Ambien or Vicodin (a prescription opiate) and other controlled substnaces. The lexicon is confusingly different in Canada and important to explain here! In Canada, Schedule II drugs, while not as strictly regulated, do still require professional intervention from the pharmacist at the point of sale and possibly a referral to a practitioner. Click here for the drug schedules regulations in British Columbia.
And did you know that when you’re crossing the border, the U.S. Customs Border Patrol (CBP) is not allowed to stop the importation of FDA-approved medication from Canada for personal use – even though it’s technically prohibited? See: Public Law 115-31. Now you know!
Something to keep in mind for those Americans ordering medications from Canada (or from any other country) through a PharmacyChecker-verified online pharmacy: you must have a prescription if a prescription is required in the United States even if one is not required elsewhere!
So, in practice, insulin products can be sold in Canada without a prescription after consultation with a pharmacist. Sound great? It is! Nevertheless, be sure to give that friendly Canadian pharmacist a call to make sure they can help you before filling up your tank for that road trip to Toronto.
Tagged with: Canada Pharmacy, diabetes, Drive to Canada, Insulin, Type 1 Diabetes, Type 2 Diabates
By way of the craftiest of PR snakes, pharmaceutical companies infest the media, politicians, and consumers with the idea that if we expressly permit people to buy lower-cost medications from other countries, we break the “closed” pharmaceutical distribution system. This concept of a “closed” system is sadly overplayed and misleading.
The U.S. Food and Drug Administration (FDA) is one of the leading drug regulatory authorities, but as the pharmaceutical industry continues its propagandistic efforts against legalizing importation of lower-cost medication, the myth making has got to be called out. You’ll have to forgive me for the lengthy post: I’ve chosen to include long quotes from experts—perhaps to offset my frustrated tone—but mostly to properly inform you what we’re up against.
The fact is, you can trust the safety and efficacy of medications sold in the U.S., but NOT more so than Canada or many other countries. People are not paying attention to the perpetual lies Big Pharma regurgitates on this issue. In a follow-up post, I’m going to discuss myriad ways that the FDA is doing a much better job, but, for the moment, excuse me while I blow off sufficient “What-the-hell-is-going-on?!” steam. (more…)
Tagged with: closed, coukell, drug distribution, FDA inspections, GAO
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
American medications are usually imported. Now you know.
Yesterday, PharmacyChecker released the findings of our new research that shows 70% of brand name medications sold in U.S. pharmacies are not made in America. Those same medications can be purchased at 70% less in Canada – and even less in other countries. As I’ve written before, there’s a troubling aspect of the public policy debate about drug importation: in many news stories, both policy-oriented and those dedicated to consumers, it seems as if drug importation is currently illegal, which is simply not true. Our data indicates that when Americans walk into their local Walgreens or CVS to fill a prescription, the pharmacist will mostly likely dispense an imported drug – that’s if the patient can actually afford it: 45 million did not fill their prescription last year because of cost.
Our findings come in the wake of an announcement from the Congressional Budget Office about The Affordable and Safe Prescription Drug Importation Act of 2017 (S.469), which aims to make it expressly legal to import lower-cost medications from Canada. CBO’s report shows that if S.469 becomes law, it would shave almost $7 billion off the deficit by 2027. We believe the savings would be much greater. The CBO report reflected deficit savings, but did not include the savings that individuals would also realize from buying lower cost medications from Canada. (more…)
Tagged with: affordable and safe prescription drug importation act, CBO, foreign made, S.469