The U.S. Department of Health and Human Services (HHS) announced this week that it and the FDA are publishing a Safe Importation Action Plan with two pathways for drug importation of certain drugs from foreign markets. HHS Secretary Alex Azar stated that this “announcement outlines the pathways the Administration intends to explore to allow safe importation of certain prescription drugs to lower prices and reduce out of pocket costs for American patients. This is the next important step in the Administration’s work to end foreign freeloading and put American patients first.”
In response to this announcement, Partnership for Safe Medicines Executive Director Shabbir Safdar released a statement criticizing this “reckless and politically-motivated” proposal: “Today’s gimmick by Secretary Azar and Commissioner Sharpless doesn’t equate to responsible governing. It’s regulatory surrender that is unsafe and will not bring down prices in any meaningful way. Voters, pharmacists, patients, law enforcement officers and other stakeholders are watching in full view, likely with one question in mind: Why on earth would our government seek to put lives at risk to pursue a policy that doesn’t work?”
PhRMA’s CEO Stephen J. Ubl also released a statement in opposition: “The Administration’s importation scheme 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 the FDA. Law enforcement has repeatedly warned that importation schemes could worsen the opioid crisis and jeopardize public safety. Moreover, Canadian officials have said that the policy is unworkable, and they will not risk shortages by diverting their medicine supply to the United States.