The Trump administration announced plans to allow the importation of drugs from other countries, a major part of President Trump’s agenda for lowering the cost of prescriptions.
“This is the next important step in the Administration’s work to end foreign freeloading and put American patients first,” Health and Human Services Secretary Alex Azar said Wednesday.
The proposal, the Safe Importation Action Plan, calls for a rulemaking to authorize state, wholesaler, or pharmacy plans to try to set up drug importation programs that abide by FDA safety standards. The FDA would also work with manufacturers to assure that the drugs sold to foreign countries abide by FDA regulations to be sold in the U.S.
“We are open, there is a pathway,” Azar said. “We will lay out the criteria for states, wholesale retailers, and pharmacies to see that they have a workable plan to lower costs and protect American consumers. But they must work with us and convince us that you have a plan that works.”
Azar said he has spoken with Canada’s health minister, as Canada has been the country most frequently referenced for drug importation, about how the plan will be carried out. He reiterated that execution will rely on state-made plans.
“Those will be issues for states, pharmacies, and wholesale distributors to work out,” Azar said. “How to get tracing and tracking, get relabeling, maintain the supply chain. That is for them to work out.”
Florida Gov. Ron DeSantis announced a plan to begin drug importation in February, and said he has the president’s full support.
The powerful drug lobbying group PhRMA has resisted drug importation, citing safety risks to American consumers. The Canadian government has also been reluctant to sign on to importation proposals, saying importation would deplete the country’s own supply of prescription drugs.
GOP legislators have traditionally opposed drug importation on grounds of safety risks to patients.
Azar said that Health and Human Services and the FDA have not yet spoken to big pharmaceutical companies about the two proposals yet.