PDSA Position Statement on Administration’s Importation Final Rule
The Pharmaceutical Distribution Security Alliance (PDSA) released the following statement on the Department of Health and Human Services’ (HHS) final rule permitting the establishment of programs to import prescription drugs from Canada.
PDSA has significant concerns with HHS’ final rule allowing for the importation of prescription drugs from Canada. PDSA and its members, which span the entirety of the pharmaceutical supply chain, believe the final rule, if implemented through the approval of Section 804 Importation Plans (SIPs), will undermine the safety and security of the U.S. drug supply chain and jeopardize patient safety. The pharmaceutical supply chain has expended incalculable time and resources over the past seven years to implement the important protections of the Drug Supply Chain Security Act (DSCSA) and enhance the security of the U.S. supply chain. Approval of a SIP will immediately undermine years of progress by impeding interoperability, creating gaps in critical data for the tracing of drugs, slowing investigation processes, and jeopardizing data integrity.
We urge FDA to fully consider the implications of any proposed SIP on supply chain security and the ongoing implementation of the DSCSA protections. We firmly believe that a SIP that does not fully and completely comply with all DSCSA obligations inherently poses additional risk to the public’s health and safety.