A plan to allow Florida to import cheaper prescription drugs from Canada has already faced anger from Canadians who say it could worsen their own drug supply shortages. And U.S. experts question whether the program will help Floridians reduce the cost of medications for conditions such as heart disease and diabetes.
The federal government has been trying for years to lower prescription drug prices, but is a shaky plan to import prescription drugs from Canada the best the United States can do?
“The United States needs to solve its drug pricing problem domestically, and not by relying on other countries to solve it,” said Dr. Joel Lexin, professor emeritus at York University's School of Health Policy and Management in Toronto.
under new policy Last week's Food and Drug Administration approval will allow Florida's state government to buy large quantities of prescription drugs directly from wholesalers in Canada, where drug prices are often lower than in the United States.
Dr. Jacalyn Duffin, professor emeritus of medical history and medicine at Queen's University, said: “It's almost comical to think that the United States is trying to solve the price problem with Canada's already maxed-out drug supply.'' ” he says. Located in Kingston, Ontario.
Other states seeking bulk imports of pharmaceuticals
Efforts to allow states to buy bulk prescription drugs from Canada have been in the works since at least 2019, when the Trump administration launched a preliminary plan.
The Biden administration has taken its own steps to reduce health care and prescription drug costs, including signing the Control Inflation Act, which lowers insulin costs for Medicare enrollees. However, this is the first time the FDA has allowed large-scale imports of pharmaceutical products.
On Monday, the Biden administration Stacey Sanders appointed He will become the Department of Health and Human Services' first chief competition officer, making it a priority to eliminate what he calls “corporate greed” in the health care sector.
“This effort just builds on what we're already doing,” Sanders said of the FDA's move in an interview. “As an agency, we will continue to use every tool at our disposal to lower prices and increase competition.”
Sanders did not say whether Canada's import plan would have a significant impact on U.S. prescription drug prices, instead pointing out that anti-inflation legislation is a “central part” of the Biden administration's agenda.
“Our goal is to build and expand that effort as much as possible,” she said.
Asked about Canada's objections, Sanders referred the question to the FDA.
The FDA did not respond to requests for comment.
At least eight other states (Texas, Colorado, North Dakota, Vermont, Wisconsin, Maine, New Hampshire, and New Mexico) have passed similar laws, but many require FDA approval first.colorado submitted a proposal to the FDA in 2022, and said it will submit an updated proposal to the FDA early this year.
F.D.A. rejected the proposal From New Hampshire in 2022.
Although the United States only recently gained the authority to negotiate drug prices with pharmaceutical companies, the Canadian government has been engaged in such negotiations for many years, which has helped manage and limit drug price increases in the country. .
Since the FDA's decision, the Canadian government has taken steps to block the export of prescription drugs in short supply to the United States, said Ann Genia, a spokeswoman for Health Canada, the country's public health agency. mentioned in.
It requires that Canadian wholesalers, under the country's laws, have “reasonable grounds to believe that the distribution will not cause or exacerbate a shortage of the drug.” “We have an obligation not to distribute medicines to other groups unless there is an obligation to do so,” Guenier said. In Canada. “
“Large imports will not be an effective solution to America's high drug price problem,” she said.
according to global news“We cannot allow Florida or any other foreign jurisdiction to threaten Canada's medical supply,” Canadian Health Minister Mark Holland said at a news conference in Nova Scotia on Wednesday, according to The Canadian Press.
Currently, 10% to 15% of pharmaceuticals in the canadian market According to Leksin, there is a shortage.
How long will it take for my medicine to arrive from Canada?
Lawrence Gostin, director of Georgetown University's O'Neill National Institute for Global Health Law, said Canada may not need to worry for a while.
The reason is that in order for Florida to begin importing a drug, it must provide FDA with details of the drug being imported, verify its authenticity through testing to prevent counterfeiting, and obtain FDA-approved products. He said this is because certain criteria must be met, including adjusting the label to meet the standards.
Additionally, the FDA outlined that Florida will be required to submit quarterly reports to FDA on imported drugs. The agency said the report should include information on imported medicines, economic savings generated and safety and quality concerns that may arise from the new policy.
Florida Governor Ron DeSantis' office and the Florida Department of Health did not respond to requests for comment.
Canadian resistance and regulatory hurdles mean Floridians could wait years, if at all, to get the cheaper drug, said Stacey Dusetsina, a health policy professor at Vanderbilt University in Nashville, Tennessee. said.
“There are so many additional steps required at these stages by a necessary and unwilling partner that it seems very unlikely that this will actually lead to the importation of drugs in the near future or ever,” she said. said.
AARP has been urging the U.S. to allow states to import low-cost prescription drugs.
AARP Florida Director Jeff Johnson said Florida still needs to develop procedures for testing prescription drugs and a process for changing the labels of drugs it plans to import from Canada.
He noted that parallel to Florida's 2019 program allowing drug imports from Canada, there was another program that expanded its scope to include imports from a broader range of countries. That program was never implemented, he said.
“If this becomes a U.S. vs. Canada issue, what will likely happen is an expanded discussion to look broadly at other countries that also pay much lower prescription fees than Americans. I think so,” he said.
While Canada's options are limited and the Canadian government may not be able to directly influence U.S. policy, York University's Leksin said European countries have done much for coronavirus vaccines during the pandemic. Similar measures, he suggested Canada may impose export restrictions.
“I don't see a problem with imposing export restrictions,” he said. “And certainly the Canadian government has indicated that they will do that if necessary.”
