- The U.S. Food and Drug Administration (FDA) approved a plan this month by Florida to import certain lower-priced medications from Canada.
- The move is estimated to save the state around $150 million annually in medication costs once the program is fully running.
- The drugs will cover a variety of conditions and will be made available to Medicaid enrollees, inmates and others.
The Food and Drug Administration (FDA) approved Florida’s request to import certain prescription drugs from Canada, which will open the way for the state to obtain drugs at lower prices than in the United States.
The
Florida plans to import medications for HIV/AIDS, diabetes, hepatitis C, mental illness, and other conditions. The drugs would be made available to residents enrolled in the Medicaid program, inmates, patients at county health departments managed by the State Department of Health, and others.
The state estimates that it will save up to $150 million annually once the program is running. Florida Gov. Ron DeSantis said later in an interview that the plan would save the state $100 to $200 million a year.
The approval comes as the 2024 presidential election approaches, with many Americans still concerned about the high price of prescription drugs.
A KFF poll from last year found that about eight in 10 American adults said the cost of drugs is unreasonable. In addition, nearly 80% of people were in favor of Americans being able to buy prescription drugs imported from Canada, according to a separate KFF poll.
“There’s a lot of pressure from the general public to reduce the costs of medications,” said Dr. Paul Peak, vice president of clinical pharmacy at Sedgwick.
“Look at the Inflation Reduction Act as one step in that direction, where Medicare now has the ability to negotiate the price of 10 medications — something it couldn’t do before,” he told Healthline.
Since 2005, U.S. law has allowed wholesalers and pharmacists to import certain Canadian drugs, but only if the imported drugs were safe and significantly reduced the cost to American consumers.
Not much action occurred with this provision until 2020, when the Department of Health and Human Services published a final rule and final FDA guidance allowing states and Native American tribes to propose plans for the importation of drugs.
Florida and several other states — including Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont, and Wisconsin — have submitted plans or are planning to seek approval.
In 2021 the Biden Administration moved this process forward, directing the FDA commissioner to work with states and Native American tribes interested in developing an importation plan.
After applying to the program, Florida later sued the FDA, accusing the agency of “reckless delay” in approving its plan. A federal judge set Jan. 5 as the deadline for the agency to respond to the state’s application, reports The New York Times.
Dr. Robert M. Califf, the FDA commissioner, said in a
Several hurdles remain before Florida can start importing medications from Canada.
This includes meeting certain
In addition, the state must ensure that the drugs it intends to import have been tested to show they are authentic and comply with the FDA’s specifications and standards.
Once Florida’s importation program is running, the state must also submit a quarterly report to the FDA with information about the imported drugs, the cost savings, and any potential safety and quality issues.
“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” said the FDA’s Califf.
Florida’s plan is authorized for two years from the date the FDA is notified of the first shipment of imported drugs.
Melissa Tice, PhD, an adjunct professor of clinical research and leadership at the George Washington University School of Medicine and Health Sciences in Washington, D.C., said prescription drugs approved by Health Canada, which is responsible for the country’s health policy, require the same level of effectiveness and safety as the FDA.
“Therefore the quality, safety, and the efficacy of the product is no different [than] what is currently available in the U.S.,” she told Healthline.
The big difference is that the cost of prescription drugs in Canada is cheaper. Drug prices in Canada are 28% to 46% of the prices in the United States, according to KFF.
“If approved, [the importation plan] will significantly reduce the cost of the identified prescription drugs for patients in the respective states and Indian tribes,” said Tice.
However, Peak questions whether this will have a broad impact on Florida consumers.
“The list of medications submitted [by Florida] for approval by the FDA for import is very small, and are primarily for expensive HIV medications as well as other expensive medications that treat mental health issues or prostate cancer,” he said.
Instead, Florida’s plan is designed to reduce state costs by providing lower-priced medications through Medicaid or state-run programs or facilities, he said.
“It is also important to remember that a large number of [less expensive] generic drugs are already imported into the U.S. every day with the approval of the FDA,” said Peak. “This situation with Florida is unique in that the FDA has made a path to import U.S. branded medications, and has finally approved one of several state applications.”
One reason drug prices are lower in Canada is that its government has various mechanisms for lowering the cost of prescription drugs, including ordering the holder of the drug’s patent to lower the price.
The Inflation Reduction Act promoted by President Biden offers similar, although more limited, measures to control the cost of prescription medications in the United States.
This includes a $35 cap on a month’s supply of insulin, a limit on annual out-of-pocket drug costs, and allowing Medicare to negotiate the price of certain drugs.
Importing drugs from Canada will offer another potential way for Americans — or states — to save money on prescription medications. However, this route faces opposition.
The Pharmaceutical Research and Manufacturers of America, known as PhRMA, issued a statement saying it is “concerned” about the FDA’s decision to approve Florida’s importation plan, and that it “is considering all options for preventing this policy from harming patients.”
In addition, “Canada is limited in the amount of medications that it can export, not to mention the bigger question of whether it will even agree to do so,” said Peak.
With a population of around 40 million people, Canada’s drug market isn’t that much larger than Florida, which has a population of 22 million, not to mention other states that may want to import drugs from north of the border.
To protect its own citizens, Canada introduced a measure in 2020. banning the distribution of certain drugs outside of the country if it would cause or worsen a shortage of the medication.
“The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need,” Health Canada said Jan. 8 in a statement.
“[The Canadian government] has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the U.S.” the agency added.
Peak agreed: “This approval [of Florida’s drug importation plan] by the FDA is a small step to help a state reduce its own costs, but is not a panacea by any measure for the larger public.”
“The bigger picture is that the U.S. has a problem with providing affordable medications, compared with other countries,” he said, “and it’s going to take a larger effort within the U.S. to address the problem, as opposed to looking outside our country for the answers.”
The FDA approved Florida’s plan to import from Canada lower-priced medications for the treatment of medications for HIV/AIDS, diabetes, hepatitis C, mental illness and other conditions.
Before the drugs can be imported, the state must take several steps to ensure that the drugs are safe and effective, and that they comply with all FDA regulations.
The government of Canada may block the flow of certain drugs into the United States if it will lead to or worsen a drug shortage in Canada. The Pharmaceutical Research and Manufacturers of America, known as PhRMA, may also take steps to block Florida’s plan.