“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,” according to a statement from the American Pharmacists Association, the Academy of Managed Care Pharmacy, the American Association of Colleges of Pharmacy, the American Association of Psychiatric Pharmacists, the American College of Clinical Pharmacy, the American Society of Health-System Pharmacists, the Hematology/Oncology Pharmacy Association, the National Alliance of State Pharmacy Associations, the National Association of Boards of Pharmacy, the National Community Pharmacists Association, the Society of Infectious Disease Pharmacists, and dozens of state and territorial pharmacy groups.
In early January, the FDA authorized Florida’s Agency for Health Care Administration to import certain drugs under specific conditions. Under current law, the 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. The pharmacy groups pointed out that FDA’s announcement did not contain any data or information that assure that the standard has been met.
The authorization came under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). “This is the first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada,” the FDA said, adding that it might authorize section 804 importation program (SIP) proposals from states or Indian tribes to import certain prescription drugs from Canada if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety.
President Joe Biden’s Executive Order on Promoting Competition in the American Economy directed the FDA to work with states and Indian tribes on these plans to reduce costs to American consumers while supporting public health and safety.
Florida’s SIP is authorized for 2 years from the date the FDA is notified of the first shipment of drugs to be imported.
The FDA pointed out that, before drugs can be imported, Florida’s Agency for Health Care Administration must:
• Submit additional drug-specific information for the FDA’s review and approval
• Ensure that the drugs Florida seeks to import have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards
• Relabel the drugs to be consistent with the FDA-approved labeling.
In addition, the state group must submit a quarterly report to the FDA that includes information about the imported drugs, cost savings, and any potential safety and quality issues.
“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” FDA Commissioner Robert M. Califf, MD, said in a press release. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
The pharmacy organizations suggested that the program has too many potential pitfalls, explaining, “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.”
The statement notes that Canada does not have a law similar to the Drug Supply Chain and Security Act (DSCSA), which 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,” according to the pharmacy associations.
The groups said they want to work with the FDA and other policymakers “to implement meaningful solutions to lower the high cost of prescription drugs without compromising patient safety.”
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