The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA) has released a final rule that would help provide safe, effective, and more affordable drugs to American patients by allowing importation of certain prescription drugs from Canada.

The agencies also issued final guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.

The final rule will now allow states or certain other non-federal governmental entities to be able to submit importation program proposals to the FDA for review and authorization. It also requires states or entities to explain why their program would be expected to result in significant reduction in the cost of covered products to the American consumer and prove importation would not compromise patient safety.

Your ACC submitted comments supporting the concept of drug importation giving patient access to affordable prescription drugs consistent with ACC principles in response to the proposed rule in early March. Drug pricing and patient access issues are a key part of the College's policy priorities and the ACC continues to advocate for affordable access for all patients.

Keywords: ACC Advocacy, Prescription Drugs, Patient Safety, United States Food and Drug Administration, Canada, Drug Costs, Costs and Cost Analysis

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