Increasing Drug Importation To Lower Prices for American Patients

In simple terms

This executive order directs the Secretary of Health and Human Services to expand safe importation of lower-cost prescription drugs, including facilitating waivers for individual drug importation, authorizing insulin re-importation for emergencies, and completing a rulemaking process to allow importation of certain drugs from Canada.

Federal Register Open PDF 85 FR 45757

Record & deadlines

Jul 24, 2020Signed
Signed by the President
Jul 29, 2020FR published
Published in the Federal Register · 85 FR 45757
Federal Register PDF
Date TBD
Complete rulemaking process for proposed rule implementing section 804(b)-(h) of FDCA for Canadian drug importation

Key directives

HHS shall facilitate grants of waivers for individual prescription drug importation under FDCA section 804(j)(2)
HHS shall authorize re-importation of insulin products upon finding of emergency medical care need under FDCA section 801(d)
HHS shall complete rulemaking to implement FDCA section 804(b)-(h) for Canadian drug importation

Who is ordered

Secretary of Health and Human Services · Department of Health and Human Services

What to expect

Immediate

EO directs HHS to take action to expand drug importation

Near term (90d)

Completion of rulemaking process for Canadian drug importation (proposed rule already in progress)

Long term

Potential structural changes to U.S. pharmaceutical pricing if importation programs are successfully implemented and expanded

Risks & tensions

EO uses permissive language ('as appropriate and consistent with applicable law') which may limit binding force
Section 804(j)(2) waivers are narrow and individual-specific; unclear how much volume this can achieve
Canadian supply constraints may limit practical scale of importation program
Pharmaceutical industry legal challenges to final rule likely
Rulemaking completion timeline is vague—no specific deadline stated