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FDA allows Florida to import drugs from ;Canada

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The FDA will allow Florida to import drugs, but under certain conditions. (Archives)


US authorities on Friday authorized Florida to import prescription drugs from Canada, making it the first state to win approval for a plan to bring cheaper drugs to Americans.

Republican Governor Ron DeSantis signed the plan into law in 2019, but it required federal review and approval from the Food and Drug Administration [FDA, Food and Drug Agency, which controls imports of prescription drugs.

President Joe Biden supports such programs as a way to lower prices. He signed an executive order in 2021 that directed the FDA to work with states that want to import drugs.

In the past, Mr. DeSantis has said he estimates that the state could save $150 million per year by importing its drugs from Canada.

In a press release sent to the media, representatives of the Canadian government wants to be reassuring in the face of possible drug shortages.

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For its part, the American pharmaceutical lobby says it is outraged by this decision.

In a media statement, federal Health Minister Mark Holland said Friday that Canada has regulations in place to protect its supply. I want to assure Canadians that they will continue to have access to the medications they need when they need them, he said.

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Canada's Minister of Health, Mark Holland, wanted to be reassuring in the press release sent on Friday. (Archives)

Canadians can be assured that our government will continue to take all necessary measures to protect Canada's drug supply.

In 2019, the President Trump introduced executive orders to allow bulk imports of prescription drugs, promising it would be a game-changer for America's seniors.

A few months later, the Canadian government restricted bulk exports of certain prescription drugs to avoid the risk of shortages in the country.

Our health system is a symbol of our national identity and we are determined to defend it, declared the Minister of Health at the time, Patty Hajdu.

Since 2017, 10% to 15% of drugs marketed in Canada have been in shortage at some point and nearly half (44%) of drugs marketed in Canada have experienced at least one shortage, reads a publication from Health Canada 2021.

President Joe Biden continued in the same vein as the Trump administration, albeit too slowly, according to Mr. DeSantis . Florida filed a lawsuit in 2022 accusing the FDA of delaying approval of the importation program.

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MM. Trump and DeSantis in November 2019. Mr. DeSantis today faces Mr. Trump in the race for the Republican nomination for the US presidential election. (Archives)

Several other states – including Colorado, Maine and Texas – are also awaiting such federal approval.

Pharmaceutical industry lobby group Pharmaceutical Research and Manufacturers of America released a statement Friday. We are deeply concerned by the FDA's ill-considered decision to approve the State of Florida's importation plan, it reads.

Importing unapproved drugs, whether from Canada or elsewhere in the world, poses a serious health hazard public, said Stephen Ubl, CEO of the group, in an email sent to Reuters.

For his part, David Renwick, interim president of Innovative Medicines Canada, which represents Canada's innovative pharmaceutical industry, clarified in a press release that the American market is almost 10 times larger than the Canadian market and that the fact of x27;allowing the export to the United States of drugs intended for the Canadian population would harm our patients and disrupt our health care system.

The FDA said Florida's program would be authorized for two years. Imports won't begin immediately: Under federal requirements, state authorities must first test drugs to ensure they are authentic and relabel them so that #x27;they comply with American standards.

The Florida Department of Health must also provide a quarterly report to the FDA on the types of drugs imported, savings, and safety and quality issues encountered. /p>

These proposals must demonstrate that the programs would provide significant savings to consumers without increasing the risk of exposure to unsafe or ineffective drugs, a FDA Commissioner Dr. Robert Califf said in a statement.

In a press release published in 2021, Mr. DeSantis said he estimated that taxpayers could save up to $150 million per year thanks to this program.

Like most developed countries, Canada sets limits on the prices drug manufacturers can charge if they wish to enter the market.

For a long time, prescription drug prices in the United States have been the highest in the world.

In 2022, Congress passed a law allowing the federal government to negotiate prices for a small number of drugs used by seniors in the Medicare program . The first negotiations of this type are expected to take place later in 2024.

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Prescription drug prices in the United States are the highest in the world. (Archive)

With information from the Associated Press,Reuters and deCBC

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