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Ranjan Jindal
By Ranjan Jindal June 27, 2024

FDA permits Florida to import prescription drugs from Canada, but drugs unlikely to be brought in

After more than three years, the U.S. Food and Drug Administration in January authorized Florida to import select prescription drugs from Canada. 

Joe Biden made lowering the cost of prescription drugs a focal point of his 2020 presidential campaign, and promised to allow U.S. consumers to import drugs to decrease costs. The FDA finalized the first step in that process, but the state must clear several obstacles to realize its hopes of buying Canadian drugs. 

Florida submitted its request to the FDA in 2020, and a year later, President Joe Biden's administration issued an executive order allowing the FDA to work with states on drug importation programs. 

Florida's plan includes 14 drugs to treat HIV/AIDS, diabetes, hepatitis C, prostate cancer, mental illness and others. Only inmates, those covered under Medicaid, or patients served at facilities under the Florida Department of Health will have access. 

A KFF Health Poll showed 78% of people support allowing Americans to buy prescription medication from Canada. Other states including Maine, New Hampshire, New Mexico, North Dakota, Texas and Vermont have submitted similar importation requests to the FDA, but they have not yet been approved

Florida Gov. Ron DeSantis said the FDA-approved program will save his state up to $180 million this year. That does not necessarily mean Floridians will see a decrease in their out-of-pocket costs. KFF Senior Vice President Tricia Neuman said that even if importation proceeds, the savings would likely go to the state's Medicare budget, rather than lowering out-of-pocket costs for Floridians. 

Overall, experts concurred that the Canadian import movement is unlikely to bear fruit before his term ends; and, given opposition from Canada, it's unlikely to lower prescription drug costs.

"At this pace, and given opposition from Canada, I would be surprised to see [importation] happening soon," Neuman said. 

"Importation is still not underway, and I am doubtful that it will ever get off the ground," says Matthew Fiedler, a senior fellow with the Center on Health Policy at The Brookings Institution. 

Why does Canada oppose importation?

The FDA has to approve Florida's imported drugs individually to ensure they are tested and relabeled to U.S. standards before the state could start importing drugs. But the biggest hurdle will be the Canadian government.

"Canada is unlikely to ever be willing to allow drugs to be exported on a significant scale," Fielder said. "If Canada allowed drugs sold in Canada to be exported to the U.S., then drug manufacturers would demand higher prices in Canada to avoid undercutting their position in the U.S. market."

Currently, many foreign manufacturers sell prescription drugs directly to the U.S., but their manufacturing facilities are approved by the FDA and the drugs are not imported through other countries. 

Because Canada's drug prices are significantly lower than in the U.S., drug manufacturers would lose money if they sell goods to Canada, only to be imported to the U.S. These companies could instead just sell to the U.S. for higher prices, so there would be no incentive to sell in Canada. This could create a drug supply shortage for Canadians. 

"Canada's market is about the size of California. As a country, they don't have enough drugs to share with the U.S. market," said Erin R. Fox, an adjunct professor at the University of Utah College of Pharmacy. 

Health Canada issued a statement against the importation plan, prohibiting drugs from being sold outside the country if the sale could hurt Canadian drug supply. 

Fielder said the solution to cheaper prescription drugs must come within the U.S. drug market. He doubts importation is a realistic goal and doesn't believe there is much more Biden can do because countries or drug manufactures will oppose it. 

The Biden administration has taken action to domestically decrease costs. With the Inflation Reduction Act of 2022, the out-of-pocket cost of insulin covered under Medicare Part B and D plans is capped at $35 a month

The Inflation Reduction Act also forces drug companies to pay Medicare when certain drug prices increase faster than the inflation rate. As part of the Medicare Drug Price Negotiation Program, the Department of Health and Human Services selected 10 drugs for Medicare to negotiate with drug companies. The round of negotiations will end Aug. 1, and if there is an agreement, the new prices will be factored into Medicare in 2026. 

Neuman said that it's important to view the importation policy in context of the Biden administration's other actions, including "the popular proposals to allow the government to negotiate drug prices, the $35 insulin cap, the cap on out-of-pocket spending, and the inflation rebate."

Florida's case is the first time the FDA has approved importing prescription drugs for consumers.

However, none have been imported and experts expressed doubt that importation will occur anytime soon. With no movement expected soon on this promise, we rate it Stalled. 

RELATED: Biden Promise Tracker

RELATED:​ Joe Biden: Democrats' Inflation Reduction Act will allow Medicare to negotiate drug prices

Our Sources

U.S. Department of Health and Human Services HHS Announces Savings for 41 Prescription Drugs Thanks to Inflation Rebates from the Biden-Harris Administration's Lower Cost Prescription Drug Law, March 26, 2024

KFF, FAQs on Prescription Drug Importation, March 11, 2024

KFF Biden Administration Signals It's in No Rush to Allow Canadian Drug Imports, May 28, 2021

U.S. Food and Drug Administration, FDA Authorizes Florida's Drug Importation Program, January 5, 2024

Government of Canada Statement from Health Canada on FDA decision on Florida bulk drug importation plan, January 8, 2024

White House, FACT SHEET: Executive Order on Promoting Competition in the American Economy, July 9, 2021

KFF, What to Know About the FDA's Recent Decision to Allow Florida to Import Prescription Drugs from Canada, January 12, 2024

Healthline, Florida Can Now Import Prescription Drugs from Canada, Will That Lower Prices?, January 9, 2024

CNN Politics, FDA approves Florida to be first state to import drugs from Canada, January 5, 2024

Email interview with Matthew Fielder, Joseph A. Pechman Senior Fellow in Economic Studies and the Center for Health Policy, The Brookings Institution

Food and Drug Administration, statement to PolitiFact, June 20, 2024

Email interview with Tricia Neuman, Senior Vice President, KFF, June 

Email interview with Erin R. Fox, Adjunct Professor, University of Utah College of Pharmacy

Victoria Knight
By Victoria Knight July 13, 2021

Biden's executive order includes push for drug importation, but experts question feasibility

During the 2020 presidential election, one of the policy points of President Joe Biden's health care platform was that he would "stand up to abuse of power" by pharmaceutical companies. Specifically on Biden's campaign website, he promised that he would allow consumers to buy or import prescription drugs from other countries, as long as the Department of Health and Human Services deemed it safe to do so.  

Nearly six months into his term, Biden issued an executive order about promoting economic competition, which included his first move towards accomplishing his drug importation promise. 

The July 9 executive order directed that the Food and Drug Administration commissioner work with states to develop a drug importation program allowing prescription medications to be sent in from other countries, particularly Canada. 

However, multiple drug pricing experts told us that of all the policy ideas aimed at reducing the cost of prescription drugs, importation from other countries seems the most unlikely to happen. 

"Other countries are not interested in facilitating this," said Benedic Ippolito, a senior fellow in economic policy studies at the American Enterprise Institute. 

Matthew Fiedler, a fellow with the University of Southern California-Brookings Schaeffer Initiative for Health Policy, agreed. 

"This policy is unlikely to ever work as intended because Canada is unlikely to allow the export of drugs to the United States," Fiedler wrote in an email. 

That's because drug manufacturers would then probably demand higher prices in Canada, since those would become the de facto prices in the U.S., he said. "That would cause a big increase in prices in Canada that Canada likely wishes to avoid," said Fiedler. 

This is not the first time that a president has suggested importing drugs from other countries, notably Canada. Former President Donald Trump put forward the same idea during his time in office. Democrats and Republicans alike have also supported similar proposals. 

During the Trump administration, a rule was finalized allowing states to seek the FDA's permission to import drugs from other countries. Several states then passed laws to that end, but Florida is the only state to have formally applied to the FDA to request to import drugs from Canada. The agency has yet to make a decision on the request. 

The Pharmaceutical Research and Manufacturers of America, the trade industry group representing major pharmaceutical companies, sued HHS in 2020 in an attempt to get this drug importation rule overturned. The litigation is ongoing, though the Biden administration has asked for the case to be dismissed. 

In a May court filing, the Biden administration argued the case was pointless because it's unclear whether any drug importation plans from states were going to be approved anytime soon. 

Canada has also signaled its concern that enacting such a policy could trigger drug shortages within its borders, and after the Trump-era rule was finalized, the country moved to block the exportation of drugs to the U.S. that may be in short supply. 

Still, Rachel Sachs, a professor of law and drug pricing expert at Washington University in St. Louis, says the idea of Biden proposing a "rehabbed" policy isn't a bad thing.  

"Drug pricing has been a big problem for several years now, and there are many policy ideas on the table. We don't lack for policy ideas — we lack for actual implementation of those ideas," Sachs wrote in an email. "So I don't think it's concerning at all if the administration chooses to advance existing policy ideas rather than developing new ones from scratch." 

It's also important to remember that Biden has just released an executive order requesting for these things to happen. It is just a first step in a long line of steps, including issuing rules and allowing time for public comment. 

That means the details of how this drug importation policy would actually work are not yet available. The executive order calls for a report to be issued 45 days after the order with a plan that outlines the specific efforts that should be implemented to reduce prescription drug prices. 

"I assume we'll know more then," said Sachs. 

So it still remains to be seen whether drug importation under the Biden administration will become a reality or will go the way of other drug importation proposals thus far — all talk and no action. 

We rate this promise In the Works.

Our Sources

Email interview with Benedic Ippolito, senior fellow in economic policy studies at the American Enterprise Institute, July 9, 2021

Email interview with Matthew Fiedler, a fellow with the USC-Brookings Schaeffer Initiative for Health Policy, July 9, 2021

Email interview with Rachel Sachs, Treiman professor of law, Washington University of St. Louis, July 9, 2021 

Kaiser Family Foundation, 10 FAQs on Prescription Drug Importation, Oct. 8, 2021 

Kaiser Health News, Biden Administration Signals It's in No Rush to Allow Canadian Drug Imports, May 28, 2021

U.S. District Court for the District of Columbia, PhRMA vs. HHS Court Filing, May 28, 2021

NPR, Canada Blocks Export Of Medications In Short Supply In Response To Trump Plan, Nov. 29, 2020

The Wayback Machine, Joe - Health Care, accessed July 12, 2021 

The White House, Executive Order on Promoting Competition in the American Economy, July 9, 2021

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