The Food and Drug Administration announced plans on Friday to allow Florida to import medication from Canada at far lower prices than in the United States, marking a major shift in pharmaceutical policy.
“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” FDA Commissioner Robert Califf said in a press statement on Friday. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
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Congress passed a law two decades ago allowing for foreign drug importation, but federal health officials have delayed implementing the law for years due to supposed safety concerns. Then-President Donald Trump in 2020 allowed states to submit importation proposals to the FDA for review and authorization under the law, and President Joe Biden continued the policy the following year.
Under Gov. Ron DeSantis (R-FL), Florida enacted a law in 2019 allowing for the importation of drugs from Canada — a measure opposed by some conservatives and the industry. The state applied for eligibility and sued the FDA in August 2022 due to the agency’s delay in approving the request. A federal judge set Jan. 5 as the deadline for the FDA to act on the state’s application.
Lawsuit documents indicate that Florida estimates the program could save up to $150 million annually once fully implemented, with advocates of the initiative saying the funds could be used to improve Medicaid and disability programs in the Sunshine State.
Florida is the first of eight states that have applied to receive approval. Colorado’s application is still pending. New Hampshire’s was rejected in 2023, and Vermont’s was deemed incomplete by the FDA.
However, several hurdles remain in the way of widespread adoption of the cost-saving alternative.
Pharmaceutical Research and Manufacturers of America, or PhRMA, the industry’s leading lobbying organization, is expected to file suit against the measure to prevent it from taking effect.
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Other drug manufacturers have made agreements with Canadian wholesalers not to export medicines to the U.S. Canadian government officials also contend that the supply of medicine is too small to share with the U.S. and will not be a sustainable solution to ever-increasing drug costs for Canada’s neighbor to the south.
The Florida Department of Health did not respond to requests for comment.