On Friday, the Food and Drug Administration (FDA) granted approval for Florida’s groundbreaking plan to import prescription drugs from Canada. Governor Ron DeSantis, a Republican, had signed the plan into law in 2019, and its implementation awaited federal clearance from the FDA, which oversees prescription drug imports.
President Joe Biden, a Democrat, has endorsed such initiatives to address the longstanding issue of high drug prices in the United States. In 2021, he issued an executive order directing the FDA to collaborate with states on drug imports.
This policy shift signifies a departure from years of resistance by the pharmaceutical industry, which had argued that importing drugs posed risks of counterfeit or adulterated products. The FDA had previously expressed concerns about ensuring the safety of drugs originating outside the U.S.
However, the political landscape surrounding this issue has evolved, with both parties, including former President Donald Trump, increasingly supporting the importation approach.
The FDA specified that Florida’s program would be authorized for a two-year period, with the actual importation yet to commence. Before imports can begin, state officials must adhere to federal requirements, including testing the drugs for authenticity and relabeling them to meet U.S. standards.
Florida’s health department is obligated to provide the FDA with quarterly reports detailing the imported drugs, cost savings, and any potential safety or quality issues.
FDA Commissioner Dr. Robert Califf emphasized that these proposals must demonstrate significant cost savings for consumers without compromising drug safety or effectiveness.
Governor DeSantis, currently vying for the Republican presidential nomination against Trump, had previously sued the Biden administration, alleging a delay in approving the import program. Several other states are also awaiting federal approval.
The FDA’s decision is likely to face legal challenges, with the pharmaceutical industry’s trade group deeming it a “serious danger to public health.”
The White House welcomed the FDA’s decision as “a step in the right direction” and encouraged more states to pursue drug importation. The statement emphasized President Biden’s commitment to reducing the exorbitant costs of prescription medicine in the U.S.
While many individuals already purchase some medications from Canadian or Mexican pharmacies, it is technically illegal to import them. Efforts to allow state imports began under Trump, who strongly criticized industry pricing.
Florida’s proposal encompasses various drug classes, including those for asthma, chronic obstructive pulmonary disease (COPD), diabetes, HIV/AIDS, and mental illness. The initiative aims to provide cost savings for specific groups, such as foster children, inmates, select elderly patients, and eventually Medicaid recipients.
The White House and Governor DeSantis view the FDA’s approval as progress toward addressing the longstanding issue of high drug prices in the U.S. The pharmaceutical industry, however, strongly opposes the decision, expressing concerns about potential risks to public health.
