Just weeks after it gained FDA approval, pharmacy organizations have come forward to voice concerns about the safety and security of Florida’s drug importation program.
Nearly 75 pharmacy organizations across the nation have expressed concerns about Florida’s drug importation plan, which received landmark approval by the FDA on January 5.1
In a joint statement signed by more than 70 pharmacy groups and spearheaded by the American Society of Health-System Pharmacists (ASHP), the largest association of pharmacy professionals in the United States, pharmacy organizations commented on the haste with which Florida’s FDA approval was issued. Citing current law, the joint statement said that although the FDA reserves the right to authorize programs that will reduce costs without imposing additional risks to the health and safety of the American consumer, no evidence was released that proves Florida’s plan fits these criteria.
“While our organizations share concerns regarding the high cost of medicines in the United States, patient safety should not be compromised under any circumstance,” the joint statement read. “As pharmacists, we are on the front lines protecting our nation’s drug supply chain and ensuring the delivery of safe and effective medicines to our patients. State importation programs introduce several opportunities for mix-ups, mishandling, mislabeling, and other rogue activity that would place some of our most vulnerable patient communities at risk.”
Concerns regarding the practicality of drug importation programs are not new. In 2017—well before the FDA issued its approval of Florida’s program—ASHP wrote a letter to the US Senate expressing many of the same sentiments shared in the most recent joint statement.
“Canadian drugs, like all foreign drugs, are outside the realm of the United States regulatory system; there is no way to verify where they have been, the conditions in which they have been stored, and whether they have been tampered with or contaminated,” wrote Kasey K. Thompson, PharmD, MS, MBA, chief operating officer and senior vice president of ASHP in the 2017 letter.2 “This lack of regulation creates a problem for both consumers and pharmacists. Consumers do not know if the drug they are taking is safe and effective, and pharmacists cannot accurately check for drug interactions, since they are unaware of the true identity and origin of the drug.”
In both pieces, the pharmacy organizations mentioned how drug importation programs threaten the integrity of the Drug Supply Chain Security Act (DSCSA) passed in 2013. Championed by pharmacists, the DSCSA promotes the safety and security of the pharmaceutical supply chain and American consumer by tracing drugs, tracking transaction histories, enforcing saleable returns, and more.
“DSCSA imposes protections and requires documentation that follows the drug from the manufacturer to the pharmacy, so it is clear who owned the product, and that the product is legitimate,” pharmacy groups in the joint statement said.1 “Canada does not have a similar law, leaving our drug supply chain at risk under Florida’s program.”
For decades, Americans have struggled to afford necessary medications due to soaring drug costs. Highlighting the need for drug price reform, data released by the CDC in 2021 revealed that more than 8% of adults between the ages of 18 and 64 stopped taking prescribed medications because their regimens became too expensive.3 Although Florida’s program may seem like an easy fix to finally bring down out-of-pocket costs, pharmacy groups like ASHP warn it may be one that instead pulls the wool over the eyes of American consumers.
“This drug importation proposal is not a real solution,” Tom Kraus, vice president of government relations at ASHP, said in a press release.5 “The Canadian market cannot supply anywhere close to the amount of medication needed to bring down US drug prices. Patients also need to know that this approach undermines the protections that pharmacists and physicians rely on to keep our drug supply safe.”
Although Florida has estimated that its program could save upwards of $180 million once fully implemented, pharmacy organizations are demanding data that extends beyond financial projections.4 They want to know, empirically, how the state plans on keeping American consumers safe while participating in the program.
“We look forward to continuing to work with the FDA and other policymakers to implement meaningful solutions to lower the high cost of prescription drugs without compromising patient safety,” the joint statement concluded.