Florida Becomes U.S. First State to Get FDA’s Approval to Import Cheaper Prescription Drug from Canada
On Friday, Florida achieved a landmark authorization from the U.S. Food and Drug Administration (FDA) to directly import prescription drugs from Canada, marking the first instance of such approval. This strategy is anticipated to pave the way for potential reductions in medication prices.
The approval comes in light of the stark contrast in drug costs between the United States and Canada, where government-run healthcare systems engage in negotiations for individual prescription drug prices. The move aims to leverage the lower costs in Canada to alleviate the financial burden on U.S. consumers.
While the initiative holds promise for cost savings, it is not without its share of challenges. Historically, Canada’s government has resisted U.S. attempts to purchase prescription medicines, citing concerns about threats to the country’s drug supply and potential increased costs for its citizens.
Health Minister Mark Holland of Canada reassured citizens about the robust regulations in place to protect the drug supply, stating, “Canadians can be confident that our government will continue to take all necessary measures to protect the drug supply in Canada.”
However, Innovative Medicines Canada, representing major drugmakers, expressed concerns that supplying drugs to U.S. states could heighten the risk and severity of drug shortages nationwide.
Drug pricing experts also noted the complexity of implementing the importation plan, emphasizing the significant difference in population sizes between the U.S. and Canada. Despite potential challenges, some believe that the mere prospect of a state importing drugs from Canada could strengthen negotiations for discounts and rebates.
For years, proponents of drug importation policies have argued that sourcing drugs from other countries could contribute to lowering costs in the U.S., where over half of Americans are covered by private health plans. The U.S. government has taken steps toward negotiating prices, with the Inflation Reduction Act authorizing Medicare to negotiate drug prices starting in 2026.
However, the pharmaceutical industry, represented by Pharmaceutical Research and Manufacturers of America (PhRMA), has expressed deep concerns. PhRMA CEO Stephen Ubl warned about the potential danger to public health, emphasizing the risks associated with importing unapproved medicines.
Florida, having gained FDA approval, is still required to submit drug-specific information for further review and approval. Additionally, evidence must be provided to demonstrate that the imported drugs comply with FDA standards through proper testing.
Former President Donald Trump initiated the plan allowing states to submit import proposals in 2020, and President Joe Biden continued the effort in 2021 by directing the FDA to collaborate with states on these plans. Florida submitted its proposal in November 2020, and FDA Commissioner Robert Califf emphasized that other states seeking similar approvals must demonstrate significant cost savings without compromising drug safety.
