What’s New/Significant

The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) published a joint proposal, the Safe Importation Action Plan, to allow the safe importation of certain drugs originally intended for foreign markets.

Rationale

The Proposal is intended to support lower drug prices by removing importation barriers.

Scope

The Proposal provides two pathways for importing drug products: Pathway 1: States, wholesalers or pharmacists would submit demonstration plans outlining how they would import Health-Canada approved drugs that are in compliance with Section 505 of the FD&C Act. They would be required to certify that the importation of Canadian drugs poses no additional risk to the U.S. public health or safety and would result in significant cost reductions for covered products.

This pathway restricts the types of drugs that may be imported from Canada, as the drugs must already be approved by FDA and must be made with active pharmaceutical ingredients (API) manufactured at facilities that also produce API for FDA-approved versions of the drugs. In addition, the imported drugs cannot be controlled substances, biological products, infused drugs, intravenously injected drugs, drugs inhaled during surgery, certain parenteral drugs, or any drugs subject to an FDA-mandated risk evaluation and mitigation strategy (REMS).

This pathway is subject to federal rulemaking, and HHS and FDA will first need to publish a Notice of Proposed Rulemaking to authorize importation from Canada under Sections 804(b)-(h) of the Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 384(b)-(h)). The Notice of Proposed Rulemaking will seek comments on how states, wholesalers, and pharmacists will be able to demonstrate that the drug importation programs will result in significant cost reductions for the covered drug product.

Pathway 2: Manufacturers would be able to import into the U.S. similar versions of FDA-approved drugs that they sell in foreign countries. The manufacturer will need to demonstrate that the foreign version of the drug is identical to the version sold in the U.S., and will be permitted to label the foreign version for sale in the U.S. under a different NDC number.

The Proposal suggests that FDA would authorize manufacturers to utilize this importation pathway through Section 801(d) of the FDCA (21 U.S.C. § 381(d)) and subject to additional guidance from the agency.

Public Comments

The Proposal indicates that HHS may seek comments on whether manufacturers would seek to lower costs under Pathway 2, what additional elements might be important to include, and whether this pathway could more effectively be implemented by using authority under section 804. If HHS believes that costs can be lowered significantly through this pathway, there may be reduced need for the demonstration projects outlined in Pathway 1.