Increasing Drug Importation To Lower Prices for American Patients
This executive order, signed by President Trump in July 2020, directs federal agencies to pursue expanded, safe importation of prescription drugs to help lower prices for American patients. The central idea is that allowing importation from countries with lower prices—and making safe pathways for individual importation—could reduce what Americans pay for drugs, drawing on examples like parallel trade seen in the European Union. The order specifically directs actions to (1) create safe avenues for importing lower-cost drugs, (2) authorize re-importation of insulin for emergency medical care, and (3) complete rulemaking to allow importation of certain drugs from Canada. It emphasizes that any importation must be safe and consistent with existing law, and it does not create new rights or money for individuals.
Key Points
- 1Facilitate waivers to permit individual importation of prescription drugs if it poses no greater public safety risk and lowers costs, under FDCA section 804(j)(2).
- 2Authorize re-importation of insulin products when it is required for emergency medical care, under FDCA section 801(d).
- 3Complete the rulemaking process to implement sections 804(b) through (h) of the FDCA to allow importation of certain prescription drugs from Canada.
- 4Promote the broader goal of reducing price disparities by increasing cross-border drug trade and parallel importation, with the potential for price reductions similar to those observed in other regions (e.g., EU).
- 5Preserve existing statutory authorities and budget processes; the order does not create enforceable new rights or alter agency powers outside of implementing these importation goals.