Erika Lietzan is Associate Professor of Law at the University of Missouri School of Law. She is an expert in drug and device regulation, the FDA, and intellectual property. We have been in contact with her over the past week. She just published a very significant analysis of the Impression Products vs. Lexmark SCOTUS decision, specifically focused on pharmaceuticals.
Her conclusions do not give much hope to the legality of immediate import, although they do leave a narrow door open. They confirm that, in general, personal importation is possible through the FDA’s tolerance only.
Here are some critical pieces of her analysis:
[…] it’s illegal to import the foreign version of a new drug that FDA has approved. Approval of a new drug is specific to that particular product, made and labeled exactly as described in the application that FDA reviewed. If a product is manufactured in a different facility from the facilities listed in the NDA, or if it is manufactured according to different specifications, it is considered an unapproved new drug […] In plain English: it’s illegal to import the foreign version of a company’s product, even if that same company sells an FDA-approved version to U.S. consumers.
So, if the drug is different in any way from the version approved by in the New Drug Application (NDA) the FDA, it is illegal. In particular, a drug would need the right US labeling information to conform to the NDA.
What happens if the drug circulating in a foreign country is EXACTLY conforming the FDA NDA? If it is made in the US, it still cannot be imported by anyone else than the original manufacturing company. If, however, it was manufactured outside the US:
Then, yes, that product can be imported by anyone.
Essentially, for that to happen, I think it would need to have been manufactured in one of the FDA-approved manufacturing facilities, followed all the appropriate chain-of-custody rules, and packaged with the required US labeling. The latter may possibly be taken care of by @MaryPat’s suggestion: send the pharmacy the US labeling info and ask them to put it into the package. As for the rest, I am not sure how it could be ascertained – possibly someone would be able to answer this question? [@Chris, do you know? Or do you know anyone who may be able to answer that?] That may be possible, since complex drugs such as insulin have very few manufacturing facilities. The caveat is what Professor Lietzan writes in a separate communication:
It would have to be exactly the same as the FDA approved drug – NDA approval is specific to the facility, the manufacturing process, the specifications, the formulation, and so forth. It doesn’t matter if it happens to be the same active ingredient and “probably” identical (though you never know with the in-actives), coming out of the same plant, if it’s not actually the product made in complete conformity with the U.S. new drug application (down to the batch records), then it isn’t the FDA approved drug.
What if you import the foreign version of an FDA-approved insulin? Nothing new here, but a confirmation of what we know: theoretically illegal, but there is some tolerance today.
[…] as drafted, the policy does not permit you to bring back a foreign version of a drug that is actually available in the United States. No Canadian Januvia, for instance. That said, in practice, FDA doesn’t have the resources (or, I suspect, inclination) to stop those packages.
What about non-FDA-approved drugs, such as, for instance, FIASP? It is illegal, but the FDA decides to give itself some latitude, for 3-month’s worth of product use, with some limitations:
it is a long-standing policy of enforcement discretion. […] This policy applies if the drug is clearly intended for personal use [3 month’s supply only] […] More importantly for our purposes, the drug has to be intended for treatment of a serious condition for which satisfactory treatment is not available in the United States, and the drug cannot be approved in the United States.
What this means for FIASP is that a letter of medical necessity would have to justify the medical need for the insulin speed for the specific user. That would not be hard: we all need faster insulin. So, in a way, importing FIASP might be easier than Basaglar or Novolog.
In the end, the way I read this analysis is:
Before the SCOTUS ruling, there were two hurdles to importing insulin. One was that the pharmaceutical manufacturer could sue you directly for violating the patent --that one is gone. The second is that FDA rules won’t allow it – that one is still there.
The big positive in the ruling is that FDA rules are directly subject to Congress, whereas patent law is a complex matter where the courts are part of the equation. If Congress decides to alter the FDA rules, it is a much faster and less difficult path than it used to be. It is a big IF.
It is possible today to import insulin – because of FDA’s decision not to strongly enforce its policies. This is still true. Given the pressure on Congress to lower drug prices (something that actually cannot rule by fiat), it is unlikely that this FDA position will change in the next few years. And, as Erika Lietzan writes, “it may be important to remember that only the government can enforce this. There is no private right of action under the FDCA.”
A commercial importer could take advantage of the SCOTUS ruling to import an NDA-conforming FDA-approved drug with the right labeling when manufactured outside the US. Pharmaceutical manufacturers would probably have an easy time defeating such import by playing with manufactured batches and chain-of-custody to make batches available in foreign countries non-conforming to the NDA – although I could be wrong there.
Erika Lietzan’s analysis is really worth reading. It is written in very colloquial English, and easy to follow. Have a look at it – what do YOU think?