Pharmacy Organizations Raise Concerns about Florida’s Drug Importation Program

January 17, 2024

WASHINGTON – Our pharmacy organizations are deeply concerned about FDA’s recent
authorization of a state drug importation program, which could open the door for harmful and
counterfeit drugs to enter our nation’s drug supply, with no evidence that this will result in cost
savings for our patients.

FDA recently authorized Florida’s Agency for Health Care Administration to import certain drugs
under specific conditions. Under current law, FDA can only authorize importation if the program
will significantly reduce the cost to the American consumer without imposing additional risk to
public health and safety. FDA’s announcement did not contain any data or information that
assure that this standard has been met.
While our organizations share concerns regarding the high cost of medicines in the United
States, patient safety should not be compromised under any circumstance. 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.

Pharmacists have been working with manufacturers and wholesalers for over ten years to
implement the Drug Supply Chain and Security Act (DSCSA), a law that requires tracing of drugs
through the supply chain by creating a closed drug distribution system in the U.S. to protect
patients from receiving harmful drugs. 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. Canada does not have a similar law, leaving our drug
supply chain at risk under Florida’s program.

We look forward to continuing to work with FDA and other policymakers to implement
meaningful solutions to lower the high cost of prescription drugs without compromising patient