WASHINGTON — Healthcare Distribution Alliance (HDA) president and CEO Chip Davis released the following statement regarding the Food and Drug Administration’s (FDA) decision to authorize the Florida Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act.
“HDA and its pharmaceutical distributor members support efforts to address the high cost of prescription drugs. However, we remain concerned that importing medicines not intended for distribution in the United States will introduce additional challenges to the country’s secure and reliable closed distribution system. Importation programs significantly increase the likelihood of counterfeit or substandard drugs entering the U.S. supply chain.
“For more than 10 years, pharmaceutical trading partners have been hard at work implementing the federal traceability law, the Drug Supply Chain Security Act (DSCSA), and are preparing for the end of FDA’s stabilization policy in November 2024. The DSCSA, once finalized, will establish a uniform national framework for tracing prescription medicines. Importing prescription drugs — not intended or labeled for distribution in the U.S. and not supported by manufacturer verification systems — will threaten the significant progress made by the public and private sectors to create an even safer and more secure supply chain through the DSCSA.
“As the vital link in the healthcare ecosystem, HDA’s 37 healthcare distributor members work every day to deliver efficiencies across the supply chain and protect patients. Regulators and policymakers should be focused on workable solutions to our country’s access and affordability challenges — rather than quick fixes such as importing drugs not intended for distribution in the U.S. HDA and our members are committed to collaborating with the Biden administration, Congress, the states and industry partners to help ensure patient access to affordable medication.”