CNN
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The Food and Drug Administration on Friday approved Florida's request to import certain medicines from Canada, giving the state the authority to buy large quantities of low-cost drugs from overseas for the first time.
Florida's plan calls for importing drugs to treat some illnesses for residents covered by certain public programs, such as Medicaid enrollees and prisoners.
This historic move is the latest salvo in the long-running fight to lower drug prices, one of Americans' biggest health care issues and a key element of health care policy. President Joe Biden's re-election campaign. Florida Governor Ron DeSantis, who is seeking the Republican presidential nomination, has also emphasized the idea of importing drugs in an effort to reduce drug costs.
“After years of obstruction by federal bureaucrats, Florida can now import low-cost, lifesaving prescription drugs,” DeSantis said in a statement Friday. “It's time for the FDA to put patients over politics and the interests of Floridians over Big Pharma.”
U.S. law allows the importation of drugs, but this importation never gained traction due to safety and practical savings, as well as concerns from federal health officials. Fierce opposition from American drug companies and Republican lawmakers.
However, former President Donald Trump imported drugs is central to his efforts to reduce drug costs; Seeked federal approval for Florida's proposal. In 2020, the Department of Health and Human Services issued a final rule establishing a pathway for states and certain other entities to launch drug importation programs. The following year, Biden issued an executive order directing the FDA commissioner to work with states that want to develop import programs.
Mr. Biden, Mr. Trump, and Mr. DeSantis are likely to make a mark on their campaigns by starting drug imports in the United States, but there are major hurdles before Florida can actually begin importing certain medicines. It could be some time before the state and its residents realize the savings. The pharmaceutical industry is expected to continue its efforts to prevent the importation of medicines. Canada is against Large quantities of pharmaceuticals are imported.
Florida, which submitted a proposal to the FDA in 2020, originally wanted to import medicines to treat chronic diseases such as HIV/AIDS, mental illness and prostate cancer, the governor's office announced in a press release Friday. did.
The state will provide imported drugs to patients in county health departments managed by the state health department, inmates in state correctional facilities and some other populations served by state agencies. The program will then be expanded to Medicaid enrollees.
Once fully implemented, the program is expected to save Florida up to $180 million in the first year and about $183 million annually, the state said.
“We are working with importers and distributors to create a system where as a state we import pharmaceuticals from Canada, relabel them, deliver them to Florida, and ship them through various state programs.”Florida said Jason, director of the state Health Care Agency. Weeda told state lawmakers last month. “It guarantees safety. It guarantees cost savings.”
Seven other states, including Colorado, Maine, and Texas, have passed laws allowing for the creation of state drug importation programs. Some are in various stages of seeking FDA approval. New Hampshire's application was rejected in 2022 because it could not identify a Canadian wholesaler.
Florida must meet certain FDA requirements before importing drugs. Additional drug-specific information must be submitted for regulatory approval, the drug must be tested to ensure compliance with FDA standards, and the drug must be relabeled according to FDA regulations. Additionally, states will be required to submit quarterly reports on imported drugs, cost reductions, and potential safety and quality issues.
“These proposals must demonstrate that the program will provide significant cost savings to consumers without increasing the risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Robert Califf said in a statement. ” he said.
The state's plan would be approved for two years from the date the FDA is notified of the first drug shipment.
The Pharmaceutical Research Association of America, known as PhRMA, quickly issued a statement saying it was “considering all options to prevent this policy from harming patients.”
“We are deeply concerned about the FDA's reckless decision to approve Florida's import plan,” said Stephen Uble, CEO of PhRMA, a major industry group. “Ensuring patients have access to the medicines they need is important, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious risk to public health. Politicians need to stop getting between the American people and health care.”
Concerned about drug shortages at home, the Canadian government and independent experts question whether imports will do much to lower prices in the U.S., given Canada's relatively small drug market. In 2020, Canada announced measures to protect drug supplies, including banning the international distribution of certain medicines that could cause or exacerbate shortages. According to Health Canada, which is responsible for national health policy, this includes all medicines that are subject to bulk import into the United States.
“The Government of Canada is taking all necessary steps to protect the supply of medicines and ensure that Canadians have access to the prescription drugs they need, and bulk imports are an effective solution to Canada's problem of high drug prices. “We are clear that this is not a viable solution for the United States,” Health Canada said in a statement Friday night.
But some are more hopeful.
“This is an important step toward wholesale importation of drugs and making the same drugs available to U.S. residents at a lower cost,” said Senior Director of Coverage, Cost, and Value at the National Academy of State Health Policy. said Maureen Hensley Quinn. , has developed a model drug importation law that states can use.
This story has been updated with additional information.
