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The US Department of Health and Human Services proposed on July 31, 2019 the “Safe Importation Plan” which would allow the importation of foreign drugs into the US with the aim of allowing consumers to get safe and cheaper drugs.

Current Situation

The current situation in regard to importing approved drugs from outside the US is summarized in several publications from the FDA and others described below. See: https://www.fda.gov/drugs/drug-information-consumers/imported-drugs-raise-safety-concerns which has a detailed description of the current status. See also: https://www.fda.gov/industry/import-basics/personal-importation . Highlights include:







There are several issues involved in actually setting this up this proposed import plan on a large scale to cover the US.  The issues are political, logistic, regulatory, corporate and financial.


Firstly, as noted above the personal importation of drugs is largely illegal. Companies may import drugs but this is tightly regulated by federal law. FDA and other agencies regulated this and companies often manufacture drugs in a facility outside the US and the drugs are imported to the US. In order to put the Trump proposals into place there will need to be a change in the federal law and regulations. Whether Congress can get a consensus on this matter remains to be seen. It is not clear if it is a high priority nor is it clear that the proposed new system will be agreed upon by both political parties, particularly with a presidential election coming up next year. States are going in their own direction legalizing import even though federal law forbids it. This is similar to the situation today with marijuana.


The Canadians are not happy with this!



In the US and Canada, many if not most contracts between wholesalers and drug companies forbid imports by the wholesalers unless it is specifically stated in the contract that specific imports or exports can be done.  If US wholesalers started to import at lower prices they would likely be in violation of their contract.  Drug companies could bring them to court.  It is possible in the future, wholesalers would be able, when negotiating new contracts, to import the product rather than buying from the US drug company. This remains to be seen.  It would possibly impose liability on the wholesaler if they should import problematic products.


Not totally clear how this will play out. Insurance providers would certainly prefer to pay and reimburse less than they do now for the same drugs. But it is possible  that one might see US-sourced and Canadian-sourced drugs reimbursed at different rates clearly favoring the imports.

Quality Assurance

How FDA, the post office and other deliverers of drugs from Canada (or wherever) to the US can ensure that these are legitimate products of high quality (at least equal to the US-sourced) product is going to be difficult if not impossible.  This is particularly true if the product is small tablets delivered in a plain brown envelope not labeled as drugs.

Drug Companies

Drug companies certainly do not want to compete against themselves and it is entirely possible that the companies would provide to Canadian pharmacies only enough medications for Canadians and not enough for Americans.  Keep in mind that the US has about ten times the population of Canada.  The Canadians will not react well if shortages occur in Canada because of exports to the US.

Other Issues

If the plan is put in place at the state or local level rather than the federal level, there will be a very large number of different systems and permutations making a very complicated system. Could the Canadian supplier send a generic instead of a prescribed branded product especially if the generic is not approved in the US?


Pharmacovigilance Issues

So where does this leave us in regard to PV issues? Since the proposal is by no means in place, the issues raised here are those that have been present for some years. Namely, the fact is that some/many patients living near the US borders purchase drugs physically by traveling to Mexico or Canada and that some/many patients order on-line from Canadian and other ex-US pharmacies.

Even now it is possible that patients or others are reporting adverse events from drugs sourced from outside the US. It is important that the PV specialist attempt to obtain the sourcing information. That is, did the patient get it from one of the standard channels in the US (pharmacy, pharmacy benefit manager) or from another place. Patients may be reluctant to admit this as they may feel it violates the law or is something that should not be admitted to. Perhaps the best one could do is to ask the patient to read the name of the manufacturer if it is listed on the prescription bottle.

If this plays out by allowing some imports, there’s little doubt that the PV system both for the FDA and companies will become a lot more complex.


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