FDA, HHS Drug Importation Plan Out
FDA and HHS have published a Safe Importation Action Plan outlining two potential pathways to lay the foundation for the safe importation of certain drugs originally intended for foreign markets. An HHS statement says the plan outlines the pathways the Trump administration “intends to explore to allow safe importation of certain prescription drugs to lower prices and reduce out-of-pocket costs for American patients.”
Pathway 1 would use a notice of proposed rulemaking to authorize pilot or demonstration projects developed by states, wholesalers, or pharmacists and submitted for HHS review, outlining how they would import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistent with FDA approval. The statement says the notice would include conditions to ensure the importation poses no additional risk to the public’s health and safety and that the demonstration projects would achieve significant consumer cost savings.
Under Pathway 2, FDA would issue guidance with recommendations to manufacturers of FDA-approved drugs who seek to import into the U.S. versions of those drugs they sell in foreign countries. Under the proposal, the manufacturer or entity authorized by the manufacturer would establish with FDA that the foreign version is the same as the U.S. version and appropriately label the drug for sale in the U.S. HHS says that pathway “could be particularly helpful to patients with significantly high-cost prescription drugs. This would potentially include medications like insulin used to treat diabetes, as well as those used to treat rheumatoid arthritis, cardiovascular disorders, and cancer.”
Opposition in the U.S. and Canada was quickly announced. Pharmaceutical Research and Manufacturers of America issued a statement that the proposal “is far too dangerous for American patients. There is no way to guarantee the safety of drugs that come into the country from outside the United States’ gold standard supply chain. Drugs coming through Canada could have originated from anywhere in the world and may not have undergone stringent review by FDA.”
The statement quotes HHS secretary Alex Azar from 2018 that drug importation is a “gimmick” and “the last thing we need is open borders for unsafe drugs.”
Public Citizen said “Importing medicine is no national solution to our crisis of unaffordable medicine at home. Our government needs to challenge the power of drugmakers head on, beginning by negotiating prices directly on behalf of Medicare, as candidate Donald Trump promised but President Trump has failed to do. It is not clear whether the Trump administration can develop adequate safeguards to assure medicine quality and protect patients under its plan-to-make-a-plan. It may take years to design and implement the proposal, which the Trump administration must know already.”
Meanwhile, 15 Canadian healthcare organizations representing patients, health professionals, hospitals, and pharmacists signed a letter to the country’s health minister warning that the drug supply “simply does not, and will not, exist within Canada to meet such demands” (from the U.S.).
The groups cautioned that Canadian hospital and community pharmacies are resourced to serve that country’s citizens and are not equipped to serve the needs of a country 10 times its size without creating important access or quality issues. They said U.S. action could exacerbate drug shortages that have become an increasingly serious concern in the Canadian healthcare system in recent years.