The U.S. Food and Drug Administration (FDA) approved a new policy in January 2024 to allow Florida to import prescription drugs from suppliers in Canada, where drugs are often less expensive than in the U.S. While the move received bipartisan support, it was met with less favorable reactions from Canadian health providers and pharmaceutical companies.
Florida’s plan to import drugs was signed into law in 2019 by Republican Gov. Ron DeSantis, but it required review and approval by the FDA, which stated that the state’s strategy demonstrates an ability to “significantly reduce the cost of covered products to the American consumer without posing additional risk to the public’s health and safety” in a letter authorizing the plan.
The DeSantis administration estimates that the drug importation plan will save Florida $180 million in the first year of implementation. “After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” DeSantis said in a statement. “It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma.”
On the other side of party lines, the Biden administration, which has made lowering the price of prescription drugs a key part of its agenda, touted the FDA’s approval as a success. “For too long, Americans have been forced to pay the highest prescription drug prices of any developed nation in the world,” White House Assistant Press Secretary Kelly Scully said. “Today’s FDA action is a step in the right direction that can help other states apply for importation plans.”
Why are prescription drugs cheaper across the border? Because Canada, unlike the U.S. government, negotiates with drug manufacturers to better control prices for brand name drugs.
While a potential boon to U.S. consumers, Canadian drug suppliers and health providers have long opposed the idea of importing drugs into the U.S., citing potential drug shortages. “Canada has 40 million people.
Florida has more than half of that, so 22 million people. We can’t supply Florida with the drugs that they may need without doing damage in Canada,” Joel Lexchin, a retired emergency physician who studies pharmaceutical policy, told the Canadian Broadcasting Company.
After the FDA’s approval was announced, Canadian Health Minister Mark Holland publicly assured Canadians that the country has regulations in place to protect its supply of prescription medications.
“I want to assure Canadians that they will continue to have access to medications they need when they need them,” Holland said in a statement. “Canadians can be confident that our government will continue to take all necessary measures to protect the drug supply in Canada.”
PhRMA, the trade group representing U.S. pharmaceutical companies, also came out in opposition to the import plan, arguing that there could be potential health risks. “We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” PhRMA CEO Stephen Ubl said in a statement. “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.”
Pharmaceutical companies are expected to sue the federal government to stop the implementation of drug import plans. They’ve also indicated that they will not allow for more product flow into Canada than is already allocated. “The likelihood of this actually materializing is negligible,” Eric Miller, a Washington-based trade consultant, told Politico. “[The FDA knows] that the pharmaceutical companies are not going to oversupply the Canadian market.”
Even if there are no legal or supply blocks, Florida will still need to submit pre-import requests to the FDA to approve each prescription drug that it wants to import.
Thus the timeline in which U.S. consumers would see an effect on their wallets is still a ways off. That hasn’t stopped other states from trying to follow in Florida’s footsteps, however.
Seven other states, including Colorado, Maine, New Hampshire, New Mexico, North Dakota, Vermont and Wisconsin, have enacted laws allowing for drug importation. Some of those states have indicated that they will continue to look to Florida as it implements its plan over the coming months to determine the feasibility of this type of approach.
For more background, see the November 2003 issue of Congressional Digest on “Importing Prescription Drugs.”
