March 9, 2020
ARLINGTON, Va. — In response to the Food and Drug Administration’s (FDA) proposed rule on prescription drug importation, Healthcare Distribution Alliance (HDA) President and CEO Chester “Chip” Davis, Jr. released the following statement:
“As the vital link within the healthcare ecosystem, HDA’s pharmaceutical distributor members share FDA’s commitment to ensuring that Americans have access to safe, effective and affordable medicines. However, our industry has long held concerns regarding the cost and safety issues importation would pose for our nation’s healthcare system. In fact, a 2019 HDA Research Foundation analysis examining several federal importation proposals found that importation from Canada and Europe could likely result in a 5 percent increase in drug-related adverse events and patient costs of up to $1.4 billion due to increased risk in the supply chain.
“Importantly, the FDA’s drug importation proposal would undermine efforts of distributors and its supply chain partners to implement the Drug Supply Chain Security Act (DSCSA), which enables traceability of medicines from manufacturer to dispenser. As our public comments note, the DSCSA is a sophisticated and modern statute, reflecting more than 10 years of discussion and collaboration among stakeholders, all with the goal of further securing the pharmaceutical supply chain. The FDA’s proposal is fundamentally inconsistent with the DSCSA’s goals — it would not only jeopardize this work and investment, but threaten patient safety without any meaningful cost reductions.
“As an industry that works around-the-clock with trading partners to ensure a secure and efficient supply chain, HDA looks forward to engaging with the FDA to advance collaborative efforts to maintain a safe pathway for all medicines and healthcare products to reach the patients who need them.”
To read HDA’s full comment letter, click here.
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.