On the heels of Tuesday night’s Democratic debate where presidential hopefuls pitched plans to lower health care costs, the Trump administration moved to fulfill one of the president’s own pledges: lowering pharmaceutical drug costs.
The U.S. Department of Health and Human Services on Wednesday unveiled a new plan that could lower prescription drug costs. The plan includes a proposal to import FDA-approved drugs from other countries like Canada.
“For the first time in HHS’s history, we are open to importation: We want to see proposals from states, distributors, and pharmacies that can help accomplish our shared goal of safe prescription drugs at lower prices,” HHS Secretary Alex Azar said Wednesday on a call with reporters.
According to HHS, the dual-pronged plan would establish a rule that would allow various entities, like states and pharmacists, to create proposals for the FDA. The FDA would then look at how “they would import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistent with the FDA approval,” according to HHS.
The second part of the plan would have the FDA create recommendations for drug manufacturers that sell FDA-approved drugs in foreign countries but want to import those drugs to the U.S.
“To use this pathway, the manufacturer or entity authorized by the manufacturer would establish with the 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 said.
HHS noted in its announcement that this part of the proposal could also potentially lower the price of medications for insulin and cancer, among others.
Azar also called on Congress to continue working on ways to lower drug costs.
“We’ve been very pleased to see Congress take significant interest on the issue of high drug prices and out-of-pocket costs,” he said. “Action from Congress would help secure lasting improvement on many of the areas for action that the President laid out in his drug-pricing blueprint last year,” a plan he and President Donald Trump laid out in May 2018 to lower health care costs.
Republicans were quick to support the announcement. Senate Health Committee Chairman Lamar Alexander, R-Tenn., said in a statement that he welcomes the move to potentially reduce prices.
“This is the first administration to take concrete steps to allow importation of prescription drugs to reduce their cost and I welcome it," he said. "The key for me is whether this plan preserves the Food and Drug Administration’s gold standard for safety and effectiveness. Millions of Americans every day buy prescription drugs relying on the FDA’s guarantee of quality."
But there was also pushback after the announcement. PhRMA president and CEO Stephen Ubl warned against importing drugs from Canada that “could have originated from anywhere in the world and may not have undergone stringent review by the FDA.” He also argued that “importation schemes could worsen the opioid crisis and jeopardize public safety.”
“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,” he said.