August 1, 2019 – On Wednesday, HHS and the FDA released a plan to lay the foundation to import certain low-cost drugs from Canada. Insulin, biological drugs, controlled substances, and intravenous drugs would not be included. According to HHS Secretary Alex Azar, who alluded to working on a proposal with President Trump just a day earlier, the plan represents a shift in agency thinking regarding importation from foreign countries.
Congress granted states the ability to import cheaper drugs from Canada under the 2003 Medicare Modernization Act. However, the law stipulates that the HHS secretary must first verify the safety of the drug(s) – to date the secretary has never approved any proposals.
The plan has two parts:
- A notice of proposed rulemaking that creates a pilot project for states, wholesalers, and pharmacists. State governments would be tasked with developing a proposal for safe importation and submitting it to the federal government for approval. The pilots would also be time-limited and could be terminated by HHS at any time if the agency deems the project unsafe. The states, along with wholesaler who import the drugs, would also be responsible for the overall program’s success.
- Guidance from the FDA outlining safety measures for drug manufacturers who want to bring the drugs they sell in foreign countries to the U.S. The press release notes that the second pathway “would potentially include medications like insulin used to treat diabetes, as well as those used to treat rheumatoid arthritis, cardiovascular disorders, and cancer.”
Stephen J. Ubl, president and CEO of PhRMA, quickly reacted to the plan. “There is no way to guarantee the safety of drugs that come into the country from outside the United States’ gold-standard supply chain,” he said in a statement. “Drugs coming through Canada could have originated from anywhere in the world and may not have undergone stringent review by the FDA.”