CONTACT: Frank Fortin
202.223.7189; ffortin@aphanet.org

The American Pharmacists Association (APhA) issued the following statement today after the Food and Drug Administration (FDA) finalized the rule for the legal importation of drugs from Canada: 

APhA is disappointed that FDA would risk the safety and security of our nation’s drug supply by creating a complex and convoluted program allowing legal importation of certain drugs from Canada. We believe FDA’s new drug importation program is not a safe way to reduce drug prices—and puts patients at risk. 

FDA’s final rule jeopardizes patient safety by creating supply chain vulnerabilities that could potentially introduce counterfeit or unsafe drugs. It also undermines the Drug Supply Chain Security Act (DSCSA), which creates “track-and-trace” safeguards that do not exist in Canada. By commingling FDA-approved and imported versions in the marketplace, this program also creates pharmacy operation disruptions and product selection confusion and may limit patient access to medications by complicating insurance coverage and reimbursement at the pharmacy.  

Given the additional steps in the supply chain, such as relabeling and laboratory testing requirements, additional reporting systems, and the fact that most high-cost drugs are excluded from the program, it fails to produce significant cost savings to American consumers. 

“Today’s final rule threatens our drug supply by creating opportunities for mischief that could introduce unsafe drugs into the U.S. The lack of clarity around unknown, unproven cost savings does not justify jeopardizing U.S. supply chain integrity and patient safety,” said Ilisa Bernstein, PharmD, JD, FAPhA, APhA Senior Vice President of Pharmacy Practice and Government Affairs.  

APhA has long advocated against unsafe drug importation schemes that would allow the introduction of risky products into our secure U.S. drug supply chain. Together with colleague pharmacy organizations, countless concerned pharmacists, and consumers, we opposed the December 2019 proposed rule and emphasized to FDA that patient safety cannot be compromised. FDA failed to consider the thousands of comments that opposed finalizing this program. We will continue to explore ways to protect patients and the drug supply from the perils that importation may bring and to ensure patient safety is not compromised.