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Consumers have long benefitted from drugs imported from Canada. In fact, surveys have found that Americans who personally imported drugs from Canada saved an average of $4,920 in 2023 alone. However, the Food and Drug Administration (FDA) has never allowed the bulk import of medications from Canada – that is, until January of 2024, when the FDA issued an approval letter to the State of Florida, allowing it to import millions of dollars worth of drugs from Canada, over major objections by the pharmaceutical lobbies. Consumers in Florida can now benefit from drugs imported from Canada en masse. The goals of this program include consumer cost savings without adding any additional health risks. Other states like Maine and Texas have also applied to the FDA to offer similar benefits.
Why Is Florida Importing Drugs from Canada?
Florida is importing drugs from Canada for one simple reason: money. Unlike the US, the Canadian government negotiates with drug manufacturers to control drug prices, making medications less expensive. Florida estimates that it can save up to $180 million in the first year of Canadian medication importation.
Florida’s program would import medications to treat chronic illnesses like HIV, AIDS, diabetes, hepatitis C, and psychiatric conditions for use by government agencies and prisons. Medications listed for import include drugs like enzalutamide (Xtandi) and darunavir (Prezista), among others.
Governor of Florida, Ron DeSantis, said:
“We have a warehouse ready to go and the state will save hundreds of millions of dollars because I can buy the same drug there [in Canada] at a fraction of the cost, then it gets re-labeled in Florida, and then it goes out from there.”
Are Medications Imported from Canada Safe?
Medications in Canada are many times identical and, indeed, are often manufactured by exactly the same companies as those in the United States. This means there is no additional health risk to the American consumer. According to the FDA, the importation of certain prescription drugs from Canada does not impose additional risk to public health and safety.
Pharmaceutical industry lobbies such as the Pharmaceutical Research and Manufacturers of America (PhRMA) disagree, stating that:
“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan. Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health.”
It is worth noting, however, that personal importation of prescription medications from Canada has been happening for years with no evidence of a risk to health and safety. Additionally, in the case of bulk imports by the State of Florida, the Florida Agency for Health Care Administration must ensure the drugs are as potent as the equivalent drugs in the United States and are not counterfeit, adding additional layers of security to public health.
According to Mary Mayhew, president and CEO of the Florida Hospital Association, this means there will be no difference in quality between the imported drugs and those sold in the United States.
What Roadblocks Does Florida Face When Importing Drugs from Canada?
While the approval letter from the FDA was the first major hurdle Florida faced, it’s not the only one. Not all medications will be available for importation from Canada, as some drug manufacturers have agreements with Canadian wholesalers not to export their medications. Additionally, the Canadian government has put the kibosh on importing drugs that are in short supply in Canada.
According to The New York Times, “The Canadian government is likely to further restrict exports if they begin to affect Canadians, said Amir Attaran, a law professor at the University of Ottawa. He said the numbers don’t work out for a nation of nearly 40 million to supply medications for a state with 22 million people, much less for 49 other U.S. states.”
While it’s understood that the quality of drugs in Canada is the same as in the United States, the FDA is keeping a close eye on shipments. The Florida Agency for Health Care Administration must send drug information to the FDA for approval, test the drugs, and relabel them to comply with FDA standards, representing another roadblock Florida faces before offering benefits to American citizens.
The FDA will also be watching to ensure that Florida upholds strict safety rules, such as the reporting of drug side effects. Florida has two years of approval to show that its bulk importation plan offers significant cost savings to consumers.
Which Consumers Will Benefit from Drugs Imported from Canada?
Unfortunately, right now, bulk importation of drugs from Canada is only in the works in Florida, meaning only Floridians will be able to benefit in the near future.
Additionally, Mayhew notes that:
“It is currently limited to benefit individuals for certain diagnoses who are receiving their supports through the Florida Department of Children and Families, through the Department of Health, through the Department of Corrections. Now, the state is also interested in expanding that to those individuals enrolled in Medicaid.”
People eligible under the care of the Agency for Persons with Disabilities can access the drugs as well.
However, because many of the imported drugs will be used by government agencies, all Florida taxpayers will indirectly benefit from the lower drug costs.
The Benefits of Bulk Drug Imports from Canada Are Limited
Even if other States obtain FDA approval to import drugs from Canada in bulk, the benefits are still limited to the drugs the States are approved to import and the exports allowed by Canada. According to The New York Times, importing drugs from Canada does not address the root cause of high drug prices in the United States: the ability of pharmaceutical makers to fend off generic competition by gaming the patent system and the federal government’s broad failure to negotiate directly with drugmakers over cost.
It’s worth noting that Medicare will be negotiating with drugmakers for the first time over a limited number of high-cost drugs thanks to the Biden administration’s Inflation Reduction Act. Unfortunately, this, too, will only benefit a small number of people in the future, and drugmakers are suing to block these negotiations from happening.
Nicholas Bagley, a health law expert at the University of Michigan Law School, said there was a simpler solution to high drug prices than patchwork state importation programs: Having the United States government negotiate with drug companies over all drug prices, just as many other nations do.
According to Bagley:
“This whole thing is a jerry-rigged, complicated approach to a problem that’s amenable to a pretty straightforward solution, which is that you empower the government to bargain over the price for drugs. So instead, we’re sort of trying to exploit the machinery that Canada has created and that we were too timid to create.”
How to Lower Your Drug Costs If Florida’s Drug Import Plan Doesn’t Help You
Drugs in the United States cost more than 300% more than the median global price. This is likely because the United States does not place the same kind of guardrails on drug prices that countries like Canada do. For example, the Canadian government negotiates with drug companies over prices, keeping the cost of medications in their country down. The lack of similar negotiation in the United States results in Americans often not being able to fill the prescriptions they need.
While Florida is working through a bulk importation plan, this won’t address the needs of many individuals. These people may be able to benefit from the personal importation of medications from pharmacies in Canada. Americans can often save thousands of dollars a year by personally importing their medications.
For example, these medications are considerably less expensive when purchased in Canada,
• Vortioxetine (Trintellix) – An antidepressant sold by GoodRx for $439.16 and Amazon Pharmacy for $388.40. Get it from Canada for $182.59 – a 63% savings.
• Efinaconazole (Jublia) – An antifungal sold by GoodRx for $1537 (not offered by Amazon Pharmacy). Get it from Canada for $143.88 – a 91% savings.
• Sitagliptin (Januvia) – A type 2 diabetes medication sold by GoodRx for $533.41 and Amazon Pharmacy for $537.50. Get it from Canada for $136.49 – a 74% savings.
For information on saving money on medications through personal importation and how to choose a trusted online pharmacy, see here.
References
1. Canadian online pharmacies provide relief for Americans feeling the pinch in their wallet. (2023, December 4). https://www.canadianpharmacyking.com/KingsBlog/canadian-online-pharmacies-provide-relief-for-americans-feeling-the-pinch-in-their-wallet/
2. Congressional Digest » Pros and cons of importing prescription drugs. (2024, March 1). https://congressionaldigest.com/pros-and-cons-of-importing-prescription-drugs/
3. Florida becomes first in the nation to have Canadian drug importation program approved by FDA. (2024, January 5). https://www.flgov.com/2024/01/05/florida-becomes-first-in-the-nation-to-have-canadian-drug-importation-program-approved-by-fda/
4. Jewett, C., & Gay Stolberg, S. (2024, January 5). F.D.A. Issues First Approval for Mass Drug Imports to States From Canada. The New York Times. Retrieved April 17, 2024, from https://www.nytimes.com/2024/01/05/health/drug-imports-canada-florida.html
5. Office of the Commissioner. (2024, January 5). Importation Program under Section 804 of the FD&C Act. U.S. Food And Drug Administration. https://www.fda.gov/about-fda/reports/importation-program-under-section-804-fdc-act
6. PHRMA statement on FDA authorizing Florida’s importation plan. (2024, January 5). PhRMA. https://phrma.org/resource-center/Topics/Access-to-Medicines/PhRMA-Statement-on-FDA-Authorizing-Floridas-Importation-Plan
7. Pinos, G. (2024, January 15). What to know about Florida’s plan to import prescription drugs from Canada. WLRN. https://www.wlrn.org/health/2024-01-15/what-to-know-about-floridas-plan-to-import-prescription-drugs-from-canada
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