Medical Society to Study, Comment

THE CHICAGO Medical Society is monitoring the Trump administration’s Safe Importation Action Plan that would allow the importation of certain drugs into the United States originally intended for foreign markets, utilizing two potential pathways.

Under Pathway 1, states, wholesalers, or pharmacists could submit plans for demonstration projects for HHS review that describe how they will comply with the statutory safety and cost conditions as well as additional requirements that would be imposed to approve a demonstration.

The demonstrations would be time limited and require reporting and renewal and could be revoked if conditions are not met. Applications from states would need to propose an arrangement with a wholesaler or pharmacist that meets the conditions set forth in a Notice of Proposed Rulemaking.

Under Pathway 2, manufacturers could import FDA-approved drugs they sell in foreign countries, as long as the drugs are the same as the U.S. versions. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require.

The administration plans to release a Notice of Proposed Rulemaking, as well as draft guidance to begin implementation of the new plan in the coming months.

Chicago Medical Society policy supports the safe importation of drugs from Canada by individuals. However, the Safe Importation Action Plan raises several important questions. These include concerns in Canada about the potential impact on Canadian drug supplies and the exacerbation of drug shortages.

Another concern involves Pathway 2, which some believe could allow drug manufacturers to avoid the current rebate system and work around current pharmacy benefit manager contracts without significantly lowering drug prices for American patients.

Your CMS is watching the development of Pathway 2 and continues to work with legislators to lower drug prices and out-of-pocket costs for patients.