Can State-Run Canadian Drug Importation Programs Lower Drug Costs? | Simplefill

In 2024, the Food & Drug Administration gave the state of Florida permission to import certain medications from Canada. This is part of the fight to help Americans obtain the type of drug prices that other countries pay. The decision from the FDA took many by surprise because it was the first time that the FDA had made such a decision. 

Which States Have Approval from The FDA to Import from Canada?

Currently, the only state with this approval from the FDA is Florida. Six other states have put plans into place to make these importations happen, but the process has been slow-moving. Recently, Illinois, New York, and Mississippi have joined that list by filing legislation. 

How Did Florida Get FDA Approval to Import Drugs from Canada?

The process became official in 2020 via a final rule, and it was reinforced by one of President Biden’s executive orders, which directed the FDA to work with states to get the importation plans in place. 

How Long Did it Take Florida to Get Approval?

It took Florida three years to obtain approval, and the FDA has imposed a strict timeline. The state will be able to import medications from Canada for two years. To obtain the approval, the state had to show that the importation would offer substantial savings for consumers without jeopardizing health and safety. 

What Challenges Could Delay State-Run Drug Importation Programs?

Despite having obtained FDA approval, Florida is still facing an uphill battle. It will need to meet further requirements and overcome a number of other challenges. One of these challenges is the paperwork involved with each importation. 

FDA Approvals

Before the state can import medications from Canada, it has to submit a request to the FDA. That must be done for each drug. If the FDA doesn’t approve the request, Florida can’t import it. If the FDA does approve it, Florida will still need to perform rigorous quality and safety tests. 

FDA and Canadian Standards

The state must ensure the label meets FDA standards, too. It’s not only the United States that could make the process difficult. Canada could put up its own roadblocks. Canadian laws are strict when it comes to limiting the drugs sold outside of the country. There could also be fears that the exportation to the United States could reduce the amount of available medications for Canadians. 

Canada has gone so far as to make official statements that say mass importations from the country will not help the United States but could hurt Canada. 

The Pharmaceutical Research and Manufacturers of America

Another party that could cause issues for Florida and any other states that attempt the importations is the Pharmaceutical Research and Manufacturers of America, which has already filed lawsuits and even a citizens’ petition to challenge the importation plans. The group cites health and safety concerns for why it doesn’t agree with the plans. 

Will Other States Follow Florida’s Drug Importation Plan?

Whether Florida can manage these challenges will play a role in how other states pursue the plans. It may turn out not to be a feasible option for states with fewer resources, leaving patients to continue to struggle with affording their medications. 

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Frequently Asked Questions

Learn more about Canadian drug importation plans.

Who Would Benefit From These State-Run Importation Programs?

For the Florida program, those who would benefit are people who receive services via certain government and state agencies. These could include people in state-run facilities, those on Medicaid, and those served through county health departments. 

Those who are not insured or who have employer-provided insurance would not have access to the drugs. 

What Medications Would Be Eligible for Importation?

Not all medications would be eligible. For now, it appears that Florida will import drugs for HIV/AIDs, prostate cancer, and mental health conditions. 

One serious issue is that biological products will be excluded. That includes insulin, which is one of the most costly medications in the country. Not offering insulin would exclude many people from receiving the assistance they need. 

Is Canadian Importation Part of the Most Favored Nation Plan?

These importation strategies began under President Biden, but President Trump is looking closely at them as part of his administration’s Most-Favored-Nation Plan. This plan strives to offer Americans the chance to obtain medications at the same rates that other comparable countries pay.