Healthcare Docket: Will Florida’s Plan to Import Drugs From Canada Open the Floodgates?

22 Jan 2024
Patent Infringement
On January 5, the U.S. Food and Drug Administration (FDA) authorized the state of Florida to import medications from Canada in a measure to lower prices for the state’s residents. To no one’s surprise, the pharmaceutical industry has greeted the news as though it were another sub-zero arctic blast sweeping down from the Canadian prairies. The American Society of Health-System Pharmacists (ASHSP) labeled the effort futile, saying that the “Canadian market cannot supply anywhere close to the amount of medication needed to bring down U.S. drug prices.” Further, the ASHSP said it has long objected to states’ drug importation because “it has the potential to disrupt the pharmacist-patient relationship….” The ASHSP may join other groups such as the Pharmaceutical Research and Manufacturers of America (PhRMA) seeking to legally block implementation of the plan. In 2020, the PhRMA filed a lawsuit challenging importation, which a federal judge dismissed due to a lack of standing. However, the organization reportedly is preparing another suit in response to the FDA approval. Other industry groups cite a number of U.S. experts and politicians opposing the plan due to unworkability and a threat to public health. North of the border, in fear of such a development, the Canadian government published a rule in 2020 prohibiting exportation of drugs in short supply. The Canadians are likely to impose further restrictions if citizens become significantly affected, said University of Ottawa law professor Amir Attaran, according to The New York Times. A country of nearly 40 million cannot realistically supply a state of 22 million residents, he said. But industry and Canadian resistance is unlikely to substantially change public opinion. Last August, a Kaiser Family Foundation poll found that 61% of Americans are currently taking prescription medications and about 8 in 10 adults say the costs are unreasonable. Those responding to the poll taking four or more medications struggle most to afford them, with 37% saying they have difficulties paying the expense and about three in ten adults reporting not taking prescribed medicines at some point due to the cost. A Florida government press release says the FDA approval should save Floridians up to $180 million in the first year. A key question is whether the FDA approval will open the floodgates to other states receiving approval. Eight other states (New Mexico, Colorado, Texas, North Dakota, Wisconsin, Vermont, Maine and New Hampshire) have laws allowing for drug imports and are or may also seek FDA approval. Colorado has filed an application with the FDA that is pending. In 2022, the FDA rejected New Hampshire’s application due to failure to identify a Canadian supplier. No matter the outcome, it’s certain that the cost of drugs will not be an issue easily resolved anytime soon. Editor’s Note: This article first appeared in the Healthcare Docket newsletter. Click here to subscribe and read the full newsletter.
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