Weekly Policy Update: HHS and FDA Announce Plan to Allow Importation of Prescription Drugs
By: Colorado BioScience Association Date: 08/02/2019
This week the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) released a plan that describes the steps they will take to allow importation of certain drugs from foreign countries. The plan outlines two new pathways for prescription drug importation.
1. The first pathway would publish a notice of proposed rulemaking relying on the authority under Section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). If the rule is finalized, it would allow states, wholesalers, or pharmacists to submit plans for demonstration projects for HHS to review, outlining how they would import Health-Canada approved drugs that are in compliance with section 505 of the FD&C Act. The plan lays out several requirements that any demonstration project would need to include to ensure safety and cost conditions are being met.
This pathway is particularly noteworthy in light of Colorado Senate Bill 5, the prescription drug importation bill that was signed into law by Governor Polis in May. The state bill requires the Dept. of Health Care Policy and Financing to submit a request to the HHS Secretary by September 1, 2020 for a program to import prescription drugs from Canada.
2. Under the second pathway, the FDA would issue guidance providing recommendations on how manufacturers of FDA-approved products could import versions of those FDA-approved drugs that they sell in foreign countries into the United States. To use this route, the manufacturer would need to establish with the FDA that the foreign version of the drug is the same as the U.S. version. Then the FDA would allow the drug to be labeled for sale in the U.S. under a different NDC number. Unlike the first pathway, this could potentially include insulin and other biologics.
The recent announcement indicates that HHS may request comments on whether manufacturers would seek to lower costs under this pathway and what additional elements might be important to include.
It is not clear from the announcement when the proposed rule or the guidance would be released. More information about the drug importation plan can be found here.