FDA approves Florida to be the first state to import drugs from Canada

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By journalsofus.com




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The Food and Drug Administration on Friday approved Florida’s request to import certain drugs from Canada, marking the first time a state has been authorized to purchase lower-cost bulk drugs from abroad.

Florida’s plan requires the importation of medications for several diseases for residents covered by certain public programs, including Medicaid enrollees and inmates.

The historic move is the latest salvo in the long battle to lower drug prices, one of Americans’ biggest health care headaches and an important element of President Joe Biden’s re-election campaign. Florida Gov. Ron DeSantis, who is seeking the Republican presidential nomination, is also highlighting his importation proposal as he seeks to reduce drug costs.

“After years of delays by federal bureaucrats, Florida will now be able to import low-cost, life-saving prescription medications,” DeSantis said in a statement Friday. “It’s time for the FDA to put patients above politics and the interests of Floridians above Big Pharma.”

While U.S. law allows the importation of drugs, it never gained traction due to federal health officials’ concerns about safety and actual savings, as well as fierce opposition from American drug makers and Republican lawmakers.

Former President Donald Trump, however, did the importation of drugs centerpiece of its effort to reduce drug costs and pushed for federal approval of Florida proposal. In 2020, the Department of Health and Human Services issued a final rule establishing a path for states and other entities to establish drug importation programs. The following year, Biden issued an executive order directing the FDA commissioner to work with states that wanted to develop importation programs.

Although Biden, Trump and DeSantis are likely to take credit during the election campaign for starting drug importation into the US, there are still major hurdles before Florida can begin importing certain drugs, and it could be a while before that the state and its residents see savings. The pharmaceutical industry is expected to continue its efforts to prevent the importation of medicines, and Canada has opposed the massive importation of their medicines.

Florida, which submitted its proposal to the FDA in 2020, initially wants to import drugs to treat chronic health conditions such as HIV/AIDS, mental illness and prostate cancer, the governor’s office said in a news release Friday.

The state would make the imported drugs available to patients in county health departments run by the state Department of Health, inmates in state correctional facilities and certain other people served by state agencies. The program would then expand to Medicaid enrollees.

Florida expects to save up to $180 million in the first year and about $183 million annually once the program is fully implemented, the state said.

“We’re creating a system with importers and suppliers where we as a state will import drugs from Canada, relabel them, bring them to Florida and send them through various state programs that way,” said Secretary of State Jason Jason. the Florida Agency for Health Care Administration. Weida told state lawmakers last month. “That guarantees safety. This guarantees cost savings.”

Seven other states, including Colorado, Maine and Texas, have passed laws that would allow them to create state drug importation programs. Some are in various stages of seeking FDA approval. New Hampshire’s application was rejected in 2022 because it did not identify a Canadian wholesaler.

Florida must meet certain FDA requirements before medications can be imported. You must submit additional drug-specific information for agency approval, ensure that the drugs have been tested and meet FDA standards, and relabel the drugs according to FDA rules. Additionally, the state must submit a quarterly report on imported drugs, cost savings, and potential safety and quality issues.

“These proposals must demonstrate that the programs would result in significant cost savings for consumers without adding risks of exposure to unsafe or ineffective drugs,” said FDA Commissioner Robert Califf.

The state plan is authorized for two years from the date the FDA is notified of the first shipment of the drug.

Pharmaceutical Research and Manufacturers of America, known as PhRMA, quickly issued a statement saying it is “considering all options to prevent this policy from harming patients.”

“We are deeply concerned by the FDA’s reckless decision to approve the state of Florida’s importation plan,” said Stephen Ubl, executive director of PhRMA, the main industry group. “It is essential to ensure that patients have access to the medicines they need, but the importation of unapproved medicines, whether from Canada or anywhere else in the world, represents a serious danger to public health. Politicians must stop standing between Americans and their health care.”

The Canadian government, which is concerned about its own drug shortages, and independent experts have questioned whether importation would do much to lower prices in the United States, since Canada’s drug market is relatively small. In 2020, Canada announced measures to protect its drug supply, including banning the distribution outside the country of certain drugs that could cause or worsen a shortage. This includes all drugs eligible for mass importation into the US, according to Health Canada, responsible for national health policy.

“The Government of Canada is taking all necessary measures to safeguard the drug supply and ensure that Canadians have access to the prescription medications they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the United States,” Health Canada said in a statement late Friday.

But others are more hopeful.

“This is a significant step toward wholesale drug importation and US residents’ access to the same drugs at a lower cost,” said Maureen Hensley-Quinn, senior director of coverage, cost and value at the National Academy of State Health Policies. , which developed model legislation on drug importation that states can use.

This story has been updated with additional information.

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