Prescription Drug Importation

Legislative and Regulatory Position Statement

AMCP has concerns with legislative and regulatory proposals that would allow the commercial importation of prescription drugs for sale in the United States. AMCP understands such proposals are being offered to address the growing inaccessibility to affordable prescription drugs; equalize global pricing disparities; and encourage the international community to share reasonably in the costs of pharmaceutical research and development. However, as an organization representing health care professionals, AMCP cannot support these proposals since they could create undue risks to our drug supply chain and to patients, with no guarantee of a meaningful reduction in drug costs.  

Generally, legislative and regulatory language related to importation would allow states, pharmacies and drug distributors to purchase FDA‐approved pharmaceuticals from other countries to sell in the United States. The rationale behind such proposals is to use the international pharmaceutical market as a source of low‐cost prescription drugs. AMCP supports the goals of improving access to prescription drugs at lower prices and reducing overall health care costs. However, the anticipated savings generated through importation programs is uncertain.  

Several factors may influence whether significant savings will be realized from the importation of prescription drugs. How the import price compares with domestic price will vary depending on the specific drug. For example, while certain brand‐name (innovator) products sold in Canada have been shown to be priced considerably lower than in the United States, price variability exists across brand-name products. There would be no anticipated financial gain in importation of generic products, as price variability across generic products is minimal.  

Foreign supplies of drugs may be inadequate to support large‐scale importation, thus limiting the potential savings available to American consumers. Moreover, how the importation might affect the exporting country’s pharmaceutical market, such as drug shortages or drug price increases, must be considered. Finally, savings may not be fully realized because of the additional costs assumed for significant importation, such as registration fees, the transporting of products, investments in technology to secure the supply chain, and resources needed for ensuring quality and safety.  

Legislation and regulations permitting prescription drug importation also presents potential patient safety issues. For instance, quality and integrity cannot be assured with reimported products and implementing any appropriate safeguards addressing these concerns is a challenge. Prudent importation legislation must ensure maintenance of quality assurance standards throughout the international drug distribution system. In order to guarantee patient safety, agencies such as the Food and Drug Administration, the U.S. Customs and Border Protection, and the U.S. Immigration and Customs Enforcement must have the technological and financial resources to address these safety concerns. As of January 5, 2024, the Food and Drug Administration (FDA) has issued a letter authorizing the state of Florida’s Section 804 Importation Programs (SIP) proposal. The Authorization Letter states that Florida’s SIP proposal meets the statutory and regulatory requirements and that the state demonstrated that importation would reduce the cost of covered products without posing additional health and safety risk. Several other states, including Vermont, Colorado, Maine, New Mexico, and New Hampshire have passed laws allowing importation programs for prescription drugs from Canada. ¹

AMCP is concerned that importation could create undue risks to our drug supply chain and patients, with no guarantee of a meaningful reduction in drug costs and will oppose legislation and regulation that would allow the importation of prescription drugs in the United States. 

See also:

AMCP Legislative and Regulatory Positions 

Revised by the AMCP Board of Directors, February 2024

Revised by the AMCP Board of Directors, November 2020 

Adopted by the AMCP Board of Directors, February 2013  

_{1. National Conference of State Legislature.  https://www.ncsl.org/health/state-drug-wholesale-importation-programs}

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