FAQs
- Isn’t it the FDA that forbids drugs from getting imported in the US?
The FDA forbids drugs that have not been authorized for use in the US from being imported. It does not limit the import of drugs that are FDA-approved. In fact, even for unapproved drugs, it has a limited exception, covering personal use and no more than a 3-month supply:
FDA FAQs on personal import of drugs into the US
- Can drug manufacturers forbid the import of drugs another way?
Drug manufacturers typically sell drugs through resellers, with whom they have contracts that prohibit the resale into territories that are not authorized (such as other countries). They can still use contract law to stop their resellers from selling in forbidden territories. This is a very common contract clause. When it is violated, the manufacturer will typically void the contract and change the preferred pricing into a worse pricing category. However, in the case of drugs, it is often retail outlets (who buy from resellers) that sell back into the US, making it much harder to enforce.
- All all plants manufacturing an FDA-approved drug inspected by the FDA?
It appears they are: FDA FAQ on plant inspection
- Does this apply to insulin?
It applies to all branded and patented insulin analogues that are FDA-approved in the US. The following is a list of drugs that are branded that are or were patented (in some cases, such as Lantus, patent has run out): Affrezza, Apidra, Basaglar, Humalog, Humulin, Lantus, Levemir, Novolin, Novolog, Toujeo, Tresiba, ). Fiasp is not FDA-approved, and is not covered by this decision.
- Does this mean that I am now allowed to buy my insulin in Canada or Mexico?
The Supreme Court decision appears to means that, if your insulin is FDA-approved in the US, you can buy it anywhere you want inside or outside the US, and it is not illegal for you to do so. However, there may be some catches, such as chain of custody or labeling requirements, that may still create issues for such purchases.
- What are the pharmaceutical companies going to do about this ruling?
It is difficult to predict what they will do, but most likely they won’t lay low. Lisa Ouellette and Daniel Hemel have started discussing some possible loopholes in the ruling. The ones they listed there don’t apply to pharma – but more than likely there will be attempts to skirt SCOTUS’ ruling.
The discussion thread for this post is here.
This article will continue to be updated throughout the day, as news develop.
Last update: 6/1/2017 at 1:10 AM PST