FDA Testing Lower-Cost Imported Medications
Tens of millions of people have bought medications from foreign pharmacies – despite the technical illegality of importing those medications. According to reporting by Kaiser Health News last month, the FDA tested imported medications, apparently to see if what Americans are doing is safe. All medications the FDA tested “contain[ed] the ingredients matching the medicines ordered.”
The Kaiser Health News reporting was focused on international pharmacy options offered by local governments and school. While that’s interesting, it’s not breaking news (I mentioned it here). The FDA testing imports and saying the medications are safe, albeit begrudgingly, is breaking news. (more…)
Tagged with: public education, testing, transparency
Standing up for his constituents on drug prices
Last month, I blogged about the FDA Office of Criminal Investigations’ sending agents with search warrants to pharmacy storefronts in Florida that help older people buy more affordable medications from Canada and other countries. The FDA tried unsuccessfully to get one of the stores’ owners, Bill Hepscher, who runs Canadian MedStore, to sign a statement acknowledging that reimportation of prescription drugs is illegal. The Florida pharmacy storefront story was first reported in Kaiser Health News.
Yesterday, Senator Bill Nelson (D-FL) sent a letter to FDA Commissioner Scott Gottlieb demanding to know why some prescription orders coming from Canada and other countries were seized, and inquiring why the FDA raided the storefront offices.
Clearly, Sen. Nelson understands the technical illegality of personal drug imports and the need to protect people from counterfeit drugs and Fentanyl. However, his letter underscores his confusion about why the FDA is stopping people from getting non-controlled, regular prescription drugs now. He wants to know specifically if there is a change in FDA’s overall enforcement policy.
I’ve been warning about the serious public health ramifications of overzealous FDA enforcement on access to affordable medication for a long time. In 2015, I wrote a report about online pharmacies and personal drug importation, and sent it to the Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce.
Back in 2006, Senator Nelson played the leading role in ending stepped-up enforcement efforts by U.S. Customs and Border Patrol (more…)
Tagged with: Bill Hepscher, Enforcement, OCI, Scott Gottlieb, Storefront
November 20, 2017 — Kaiser Health News reported that the FDA Office of Criminal Investigations sent agents and search warrants to several companies in Florida — often referred to as pharmacy storefronts — because they help Americans place orders and fill prescriptions with pharmacies located in Canada in addition to other countries.
Read the full story here: FDA Raids Florida Stores That Consumers Use to Buy Drugs from Canada
The FDA has a lot of regulatory latitude to shape its enforcement agenda. Its efforts against counterfeit drug sales, opioid pushers (including drug companies), and rogue websites can greatly protect public health. However, we know that FDA/OCI has a history of actions more focused on protecting the profits of pharmaceutical companies.
PharmacyChecker.com opposes enforcement actions that target the safest international pharmacy options, whether via online pharmacies or storefronts, on which many Americans have come to rely because they can’t afford medications locally.
FDA has informed storefront operators that prescription drug importation is illegal and that they could face fines or jailtime for helping Americans buy lower-cost medication. (more…)
Tagged with: Enforcement, Florida, opioids, storefronts
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