A proposed rule issued by the Trump Administration, in conjunction with the US Department of Health and Human Services and the Food and Drug Administration (FDA), would allow for the importation of certain prescription drugs from Canada as part of an effort to reduce drug costs in the US.
If finalized, the rule would allow states or certain other non-federal governmental entities the ability to submit importation program proposals to the FDA for review and authorization; these programs can be co-sponsored by a pharmacist, a wholesaler, or another state or non-federal governmental entity.
In order to be approved, the sponsors would need to show that the program would not result in additional risks to public health and safety and would also lead to significant cost savings for American consumers. Prescription drugs that have been authorized for importation (products sold legally in either the Canadian or American market) would then need to undergo testing to prove that they meet established specifications and standards and would need to be relabeled with appropriate US labeling.
In addition, a draft guidance issued today describes the recommended procedures for drug manufacturers to obtain additional National Drug Codes (NDCs) for certain FDA-approved products (including biologics) that were originally manufactured in other countries. Specifically, drug manufacturers would need to include a statement on these products to indicate that they were manufactured outside of the US; this would allow for pharmacists to accurately bill for them as they would be offered at a lower price.
“The FDA continues to assess and act on multiple opportunities to promote competition that can, in turn, help reduce drug prices and improve access to medicines for Americans,” said Assistant Secretary for Health Brett Giroir. “We look forward to receiving public comment on these draft policies, and we will take timely comments into account as we work to finalize the rule and guidance.”
For more information visit fda.gov.