You may have heard that the US FDA recently approved Florida to start importing prescription drugs from Canada. So you may be asking yourself: What does that mean and why would they do that? When would it start? Should I be concerned about it? And what do I tell my patients? If those types of questions come to mind, then keep reading.

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What is the plan and why is this beneficial to Florida?

‌Back in January, the US FDA approved Florida’s drug importation program for a two year trial period, making Florida the first state to get this type of approval. The idea is by importing from Canada, it gets around the issue of the US’s extremely high prescription drug prices. Individual Americans have crossed the border for years to take advantage of our lower drug prices so why not do that through bulk importation as a state? This plan could serve as a significant cost savings to the state. As for when this could start happening, that’s unclear at the moment. 

When would it start happening?

Even though the plan itself is approved, the Florida government still needs to carry out quality testing to prove the safety and efficacy of each drug they wish to import, demonstrate cost savings to the state, as well as go through relabeling to meet US standards. In addition to that, the US FDA will need to approve each drug type that Florida intends to import. So there’s quite a few steps to get through first and bulk importation won’t suddenly start happening overnight.

What are the concerns?

There have been a lot of questions and concerns from Canadians over how this plan would affect the Canadian drug supply.  We deal with our own shortages everyday and just in the past year there’s been quite a few notable shortages such as children’s Advil and Tylenol, nitroglycerin sprays, and the ongoing Ozempic shortage. If the US started to bulk import prescription drugs originally meant for the Canadian market, it would be reasonable to think it would disrupt our drug supply. Florida’s population alone is about half of the entire Canadian population, so our supply simply can’t sustain the demands of this one state, nevermind other states also trying to gain similar approval.

What do I tell my patients?

Patients may have heard about this on the news and come into the pharmacy with questions. As we’ve experienced in the past, the common response to hearing of any potential shortage is to stockpile. However, we should be discouraging our patients from attempting to stockpile their medication as that increase in demand alone can lead to a shortage. Health Canada has released a statement that they will be “actively monitoring the Canadian drug supply and continues to ensure that Canadians have access to the drugs that they need”. To avoid causing or worsening a drug shortage, Health Canada has regulations in place to prevent certain at-risk drugs manufactured for Canadians to be sold outside of Canada. So the hope is that even if the US FDA has approved Florida to import a specific prescription medication, Health Canada won’t allow it if doing so could put our drug supply at risk of a shortage.

What to know about current personal drug importation practices

Even if there may not be bulk importation of prescription drugs to the US occurring anytime soon, this doesn’t prevent individual Americans from crossing the border to try getting their prescription drugs for cheaper. This is also known as personal drug importation and it’s important to acknowledge this practice and to be equipped with the knowledge on what’s allowed. Currently, Americans seeking to benefit from Canada's lower drug prices must obtain a prescription from a physician licensed in Canada. 

They can obtain a valid prescription by:

1. Visiting a Canadian physician at a walk-in clinic and pay out of pocket for their appointment.
2. Having a prescription written by a physician with a dual license. Some physicians in the US hold dual licenses which enables them to prescribe medications that can be filled in either the US or Canada.
3. Have their prescription co-signed by a Canadian physician. The practice of co-signing is an area of controversy as sometimes, these Canadian physicians sign off on prescriptions without directly assessing the patients.

Also keep in mind that there are some drugs that may require prescriptions in the US but don’t in Canada. These would be among our Schedule II or behind the counter drugs such as insulin or Epipens (two high cost drugs in the US). Americans would not require a prescription for these items for you to be able to sell to them.

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For more information on Florida’s drug information program and its potential impact, check out these podcasts: 

The Big Story - Is Florida coming for Canada's cheap drugs?

The Journal - Will Florida's Plan to get Cheap Drugs from Canada Work?

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References:

1. Canada H. Statement from Health Canada on FDA decision on Florida bulk drug importation plan. www.canada.ca. Published January 8, 2024. https://www.canada.ca/en/health-canada/news/2024/01/statement-from-health-canada-on-fda-decision-on-florida-bulk-drug-importation-plan.html

2. Dangerfield K. Canada issues warning as Florida plan to import drugs raises fears - National  Globalnews.ca. Global News. Accessed February 16, 2024. https://globalnews.ca/news/10210913/florida-generic-drugs-health-canada-warning/#:~:text=The%20warning%20comes%20days%20after 

3. Freed M, Cubanski J, Published TN. What to Know About the FDA’s Recent Decision to Allow Florida to Import Prescription Drugs from Canada. KFF. Published January 12, 2024. https://www.kff.org/policy-watch/what-to-know-about-the-fdas-recent-decision-to-allow-florida-to-import-prescription-drugs-from-canada/ 

4. Rawson NSB, Binder L. Importation of drugs into the United States from Canada. CMAJ. 2017;189(24):E817-E818. doi:10.1503/cmaj.170372

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