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Helping Americans Get The Truth About Prescription Drug Savings
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Senator Mike Enzi

In my blog post about the Senate Finance Committee hearing on drug prices, I noted my surprise at Senator Mike Enzi’s (R-WY) comment that he knew about a foundation that helps people import lower-cost insulin from Canada. Sen. Enzi stated that a person referred to as his diabetes advisor had “found a way to work through a foundation to import insulin for a number of people at lower-cost. And I think he worked for a foundation so that it would be legal.” I had endeavored to look into it, but fortunately Jay Hancock from Kaiser Health News beat me to it and found, sadly, no such insulin import program exists. I think we can all agree that it should!

In researching the story, Jay asked me if I knew of such a program.

Nope.

Now, Senator Enzi’s heart was clearly in the right place, but I told Jay I hadn’t a clue what he was referring to. Recall, in front of him was Kathy Sego, a mother of a young adult son with type 1 diabetes, that had testified that her son, Hunter, was hospitalized from rationing insulin due to the cost. Sen. Enzi offered to help by saying he would give Ms. Sego the name of a person who could help. I have a feeling he knows someone who imports insulin from Canada for personal use because it’s much cheaper – but the part about “the foundation” so that “it would be legal” seemed far-fetched.

Ms. Sego never got that name from Sen. Enzi.

A foundation to help Americans import insulin is a great idea

But now that Sen. Enzi mentioned it, a foundation dedicated to helping Americans import more affordable insulin from Canada is a great idea. How would it work? Basically, the foundation would identify licensed pharmacies in Canada that are able and willing to send insulin to patients in the U.S. using proper shipping protocols, ones in line with the manufacturers’ requirements for mailing temperature-sensitive products. It’s legal in Canada for pharmacies to export medicines.

The key is that private express mail couriers, such as FedEx and UPS, would have to be willing to ship the insulin overnight. That will involve pressure from the patient and activist communities. It’s my belief that the FDA has told express couriers not to do so, but it might take a Freedom of Information Act request to prove it.

Are the savings on insulin worth patients importing from Canada?

Yes, in some cases.

For people forced to pay out-of-pocket for insulin, buying from a pharmacy in Canada is often 50% cheaper on many insulin products. According to one U.S. doctor, who recommends Canadian pharmacies to his patients, for some insulin products, the prices can be ten times less in Canada.

Is it legal to import insulin from Canada?

No, but you can’t be stopped if you’re carrying it, according to U.S. law, strange as that sounds.

Americans with diabetes and their family members travel to Canada in person now to buy lower-cost insulin. Federal law prohibits Customs and Border Protection to use its funds to stop Americans from bringing back FDA-approved medicines from Canada for personal use. That’s a good start!

How about ordering insulin from Canadian mail order pharmacies?

That’s a bit trickier.

One position is that in some cases it is legal: where the drug is imported but not reimported. Those cases are when the medicine is a foreign-made, FDA-approved drug: meaning manufactured outside the U.S. in an FDA-registered establishment and is the exact same product as sold here in the U.S. (but with different labeling). Those products can be brought into compliance if the patient can show a prescription and possesses the U.S. label, which can be found here https://dailymed.nlm.nih.gov/dailymed/. FDA-approved drugs for personal import are usually deemed misbranded by the FDA but that’s not an insurmountable obstacle.

See: A Drug Importation Vocabulary Lesson: Misbranded and Unapproved Drugs

How is it that the foreign-made drug could be legal, but one made here can’t be?

Remember, there’s a ban on reimportation, except by the drug’s manufacturer or in the case of a public health crisis (21 U.S. Code § 381 (d)). Reimportation means the drug was made in the U.S., exported and then brought back. Importation (without the “re”) means it was made outside the U.S. The reimportation ban does not apply to drugs not made here but people seem to forget that.

An insulin product that could be imported for personal use and brought into compliance is Lantus Solostar. It’s made in Germany and then shipped to wholesalers in the U.S. and Canada with labeling for those countries. That drug is not subject to the ban on reimportation.

In contrast, Humalog is made in the U.S. so importing it would violate the reimportation ban. Even in this case, however, the language of the law allows the Secretary of Health and Human Services to permit otherwise unlawful prescription drug imports for personal use as long as it doesn’t present an unreasonable risk. (U.S. Code §384). The law also states that a drug could be reimported by someone other than the manufacturer if there’s a public health emergency.

Insulin costs are a public health emergency

These avenues for personal importation are not a long-term solution. We’ve got to bring insulin prices down here at home.

But give me a break!

There’s no exaggeration in the following statement: Americans are dying because insulin prices are too high. Insulin was discovered almost 100 years ago, so you’d think generic versions would be widely available and affordable. Not the case at all.

For example, Eli Lilly’s Humalog has increased in price by over 1000% since 1996.

Maybe a properly-funded foundation could help rally the forces necessary, as described above, to finally give Ms. Sego and her son and many other American families some relief. Now Senator Enzi is known to be pretty friendly to Big Pharma. But you can bet, all things considered, he’d have to applaud the establishment of a foundation that helps people legally import lower-cost insulin from Canada. Then Ms. Sego would finally get that name he promised.

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