ARLINGTON, Va. — The Healthcare Distribution Alliance (HDA) released the following statement on the release of the “Safe Importation Action Plan” by the Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA):
“Americans are rightly concerned about the rising costs of medicines. But as solutions are proposed to address the issue of affordability, importation policies of any kind will have significant implications for the safety and security of the pharmaceutical supply chain and patient health.
“As a new HDA Research Foundation study indicates, federal proposals to permit prescription drug importation would result in significant costs due to patient risks, additional regulatory oversight and the operational challenges placed on the healthcare supply chain. Notably, the study highlights that even importation policies subject to specific and well-defined restrictions would likely result in a 5 percent increase in drug-related adverse events and patient costs of up to $1.4 billion due to counterfeits and other sources of unsafe product. Finally, the hard work already underway by supply chain stakeholders to implement the federal traceability law, the Drug Supply Chain Security Act, would be jeopardized.
“Pharmaceutical distributors support efforts to address the high cost of prescription drugs. But we firmly believe the administration should focus on policies that maintain the same high standards of safety that Americans have come to rely on. Importation runs directly counter to the efforts of many regulators, the pharmaceutical industry and congressional intent — and is simply not worth the risk.”
For more information on the effects of prescription drug importation policies on the pharmaceutical supply chain, visit the HDA website.