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:
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.”