Activists with diabetes, organized through advocacy group T1International, are trekking or “caravanning” to Canada to buy lower cost insulin. Why wouldn’t they? According to reporting in the Washington Post, they ended up paying $1,200 for products that would have cost $12,000 in the United States. One vial of Humalog in the U.S. can cost $300 compared to $30 in Canada.
According to the Post, the activists “see buying in Canada as a short-term emergency measure and a way to call attention to U.S. pricing — not the answer.”
I fully agree that personal imports of more affordable medicine are an emergency measure, and I’d be happy if it were a short-term one. A recent T1International survey found that 26% of Americans who take insulin rationed their medication at least once last year because of cost. That’s higher than the worldwide rate of 18%. People with diabetes should not be forced to travel to Canada to get affordable insulin when it can be mailed.
Under most circumstances, personal imports are technically illegal. However, interestingly, U.S. law prevents Customs and Border Protection from stopping Americans importing FDA-approved drugs for personal use from Canada (See: Section 206 of Public Law H.R. 244). The protection does not extend to prescription drugs that are mailed from pharmacies in Canada to the U.S., yet it’s well known that Americans order prescription drugs through the mail and most orders get through. About 20 million people say they have imported medication to save money or even to just afford it.
It’s a question of safety when it comes to mailing temperature sensitive drugs like insulin. Once dispensed from the pharmacy, insulin can be kept at room temperature for a certain number of days, but it’s best refrigerated. And if it’s mailed, the package’s temperature should not go below 2 or above 8 degrees Celsius. Insulin could be easily packaged with appropriate temperature controls and sent internationally through overnight express mail carriers like Fed Ex and UPS. Unfortunately, I believe the FDA has warned Fed Ex and UPS not to work with pharmacies in Canada that serve patients in the U.S.
The PharmacyChecker Verification Program has a very strict policy when it comes to international mailing of insulin from Canada due to its temperature sensitivity. We do not ban Canadian pharmacies willing to ship insulin to patients in the U.S. from our program but currently none are verified to do so because they do not meet our packaging standards, which are put in place for patient safety.
For a while, on drug information and price pages relating to insulin, PharmacyChecker simply explained why we have our current policy, in addition to the regulatory and mail carrier roadblocks faced. But we realize that people are still going to try and order insulin online, despite lack of verification – and the consequences can be seriously dangerous. For those people that do try to get lower cost refrigerated medicines from Canada, we strongly urge them to speak with a pharmacy in Canada directly – not order refrigerated medicines online, or any medicine, from a website that is not verified in the PharmacyChecker Verification Program or another comparable program.
The caravans to Canada are amazing because people can get affordable insulin while bringing attention to the desperation faced by millions of Americans who need insulin to live and are struggling to afford it. And, yes, perhaps importation is merely a short-term solution. Whether it is or not: people should not have to drive or fly to a different country to get medication they can afford when it could be mailed safely.
Here are some ideas for the insulin activist community to help more people get insulin at lower cost from Canada.
Ideas for Action on Affordable Insulin
1. T1International and other groups can come up with an ideal insulin shipping policy and publicly promote it.
T1International, in consultation with public health and drug safety experts, could articulate a highly defensible policy on shipping insulin safely. In doing so, they may be able to interest and work with pharmacies in Canada to safely ship FDA-approved insulin to U.S. patients.
2. Call on Federal Express to honor its publicly stated policy: “Importation of prescription drugs by an individual U.S. consumer for personal use is prohibited unless FDA approved.” Use flexibility within the law to import medicine by mail.
The reason Fed Ex has this policy is very simple but perhaps surprising: It’s not illegal to import an FDA-approved drug.
In short, many drugs sold in Canada are FDA-approved but are packaged with different labels than in the U.S. Those labels make the drugs “misbranded” upon import. Other drugs might be Canadian versions of the same drug sold here. Those are harder to defend as lawful imports, but good arguments are available. Furthermore, people have the right to due process to defend personal imports of medication when they are refused by the FDA (Title 21 USC 301) and have done so successfully.
There is flexibility within the law that can help people with diabetes import insulin. A non-profit organization dedicated to this goal cold be successful.
3. FDA Citizen Petition Process
Someone should submit a Citizen Petition to the FDA.
“Citizen petitions are a vehicle that stakeholders outside of the Food and Drug Administration (FDA or the agency) can use to ask FDA to take (or refrain from taking) an action. Citizen petitions can pertain to any products regulated by FDA.”
These petitions, ironically, are often misused by drug companies to delay generics from coming to market. Fortunately, the FDA has taken recent, long overdue actions to push back.
In 2004, Vermont submitted a citizen petition to conduct a personal drug importation program. FDA said no. Vermont sued and lost in federal court. But I believe that a citizen petition from an individual, a “citizen patient,” who needs insulin could be successful. Such a petition would request a waiver from the Secretary of Health and Human Services to specifically procure insulin from a licensed pharmacy in Canada via overnight mail.
4. Affordable Insulin Act of 2019, HR 1478
H.R. 1478, introduced by Congressman Peter Welch (D-VT), would make it expressly lawful to import insulin for personal use from Canada. I recommend supporting this bill. It would essentially force the hand of the FDA to identify qualified pharmacies in Canada from which people could import insulin.
From a press release by Rep. Welch:
“BURLINGTON – At a press conference today at Community Health Centers of Burlington, Rep. Peter Welch (D-Vt.) unveiled legislation he has authored to provide relief from skyrocketing insulin prices to diabetes patients in Vermont and across the country. Welch’s initiative authorizes the importation of safe, low-cost insulin from Canada and other qualified countries.”
The insulin activists caravanning to Canada are an incredible inspiration to the country. I salute them.
Their efforts give voice to the American peoples’ longstanding struggle with drug prices – and healthcare costs overall. Now, I strongly recommend that they push forward—from the glove compartment of a car to the mailbox—to import insulin with express permission from the FDA or by using flexibility in the law where possible.Tagged with: caravan, Insulin, T1 International