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.
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:
- “Drug standards and regulations vary from country to country, and the FDA is responsible only for those marketed and sold inside the United States…Joe McCallion, a consumer safety officer in the FDA’s Office of Regulatory Affairs, sums it up this way: “If you buy drugs that come from outside the U.S., the FDA doesn’t know what you’re getting, which means safety can’t be assured.”
- Under the FD&C Act, the interstate shipment of any prescription drug that lacks required FDA approval is illegal. Interstate shipment includes importation–bringing drugs from a foreign country into the United States.
- The FD&C Act also states that prescription drugs made in the United States and exported to a foreign country can only be re-imported by the drug’s original manufacturer.
- The FDA recognizes that there may be circumstances in which the FDA can exercise discretion to not take action against the illegal importation:
- Product is not for treatment of a serious condition and there is no known significant health risk (Over the Counter, OTC); and
- Product is for the treatment of a serious condition (Prescription Drug Products):
- The product is for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.
- There is no known commercialization or promotion of the product to persons residing in the U.S.
- The product does not represent an unreasonable risk.
- The consumer affirms in writing that the product is for personal use.
- The quantity is generally not more than a three month supply and either:
- Provide the name and address of the doctor licensed in the U.S. responsible for your treatment with the product, or
- Provide evidence that the product is for the continuation of a treatment begun in a foreign country.
- Finally, and importantly, if a Canadian company is selling drugs only for export to the United States, and not to Canadian citizens, Health Canada may not regulate the drugs or the company at all. Drugs coming to the United States from Canada may be coming from some other country and simply passing through Canada. The drugs could also be counterfeit, contaminated, or subpotent, among other things (see “Potential Health Risks With Imported Drugs”).
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!
- As noted in the Valley News from Vermont and New Hampshire: “It’s the equivalent of Trump saying, ‘We’re going to build a wall and Mexico is going to pay for it,’ ” Andre Picard, a health columnist for Canada’s Globe and Mail newspaper, told the CBC. “It’s exactly the same thing. ‘We’re going to have cheaper drugs and Canada’s going to pay for that.’ ” See also the editorial in the Globe and Mail entitled “Donald Trump keep your hands off our drugs”.
- A fine summary of Canada’s possible actions can be found in STAT: The article notes that Canada could add drugs to the “export control list” which would require exporters to get Canadian government permission before exporting. This can be quickly set up by the government. Alternatively, new taxes or export duties could be applied to the drugs making them too expensive to import.The big fear is that there might be a shortage of drugs for Canadians if companies send too many drugs to the US. Canada is not in the business of supplying drugs to the US.
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.
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 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.
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?
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.