WASHINGTON, Jan. 17, 2024 /PRNewswire/ -- 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.
Print Page
Email to a Friend